Double-blind Comparative Study Research Articles

Efficacy of Two Different Doses of Inj Labetalol Hydrochloride for Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation in Controlled Hypertensive Patients: Prospective Randomized Double Blind Comparative Study

Background and Aim: The hemodynamic changes stemming from direct laryngoscopy and tracheal intubation represent sympathoadrenal response, which is more exaggerated in hypertensive patients. Present study was done with an aim to compare the efficacy of two different doses of Labetalol Hydrochloride in attenuation of hemodynamic response [Heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP)] to laryngoscopy and endotracheal intubation in controlled hypertensive patient and to document the side effects of the drug. Material and Method: This is prospective randomized double blind comparative study. Sixty ASA grade II controlled hypertensive patients of either sex, comprising age group of 30-65 years, undergoing elective surgeries under general anesthesia were randomly distributed in two equal groups. Inj Labetalol Hydrochloride 0.15 mg/kg in the group L0.15.so. and Inj Labetalol Hydrochloride 0.30 mg/kg in the group L0.30.so. respectively were given intravenously 5 min prior to intubation. HR, SBP and DBP were recorded at different time intervals before and after intubation. Results: There was statistically significant difference in SBP and DBP between both the group at 3,5,7,10 and 15 minute. At 5 min and 7 min post intubation, there was significant difference in HR between the group L0.15 and L0.30.so. Conclusion: Both doses of labetalol attenuate hemodynamic response to laryngoscopy and intubation in dose dependent manner. Keyword: Labetalol; Hemodynamic response; Laryngoscopy; Tracheal intubation.

English

BACKGROUND Regional anaesthesia is an armamentarium in the hands of the anaesthesiologist to provide swift, effective and safe condition for surgery. However, local anaesthetics are characterised by slower onset and shorter duration of action, when used in larger doses can cause systemic toxicity. Hence, adjuvants are used to better the quality of blocks. Here, I have used dexmedetomidine as an adjuvant in transversus abdominis plane (TAP) block to assess duration of action, hemodynamic effects and side-effects. METHODS Our study is randomised double blinded comparative study, in which we have compared two groups, one received ropivacaine alone and another received ropivacaine with dexmedetomidine as an adjuvant. Assessment was done for duration of action, visual analog scale (VAS) scores, analgesic drug usage, sedation scoring and incidence of side-effects and complications. This study was conducted on 94 parturients with 47 patients in each group. RESULTS Dexmedetomidine has a statistically significant prolonged action and has given excellent analgesia post-operatively. Additional analgesics were required in a lesser number than the control group. There were no hemodynamic disturbances and complications. CONCLUSIONS Dexmedetomidine added to ropivacaine for ultra-sound guided TAP block is associated with prolonged and excellent analgesia with lesser requirement for additional analgesic usage, lower VAS scores, hemodynamic stability, and minimal sedation. KEYWORDS Caesarean Section, Dexmedetomidine, Analgesia, Post-Operative, Ropivacaine, Transversus Abdominis Plane Block

English

BACKGROUND Postoperative pain is the most challenging task in patients undergoing knee joint surgeries under spinal anaesthesia. Spinal anaesthesia with bupivacaine provides adequate intraoperative conditions but falls short in providing prolonged postoperative pain relief. Intrathecal opioids are synergistic with local anaesthetics and intensify the sensory block without affecting the sympathetic block. This study intends to compare three different doses of intrathecal nalbuphine as an adjuvant to 0.5 % hyperbaric bupivacaine and determine the optimal dose in knee joint surgeries. METHODS A double-blind comparative study was conducted in one hundred and twenty American Society of Anaesthesiologists (ASA) I and II patients undergoing knee joint surgeries in a randomised prospective way. The patients were randomly allocated to A, B, and C groups who received 0.4, 0.8 and 1.2 mg nalbuphine respectively added to 12.5 mg of 0.5 % hyperbaric bupivacaine. The onset, duration of block, duration of effective analgesia, Visual Analogue Scale (VAS) score, and the incidence of adverse effects were studied and compared between the groups. RESULTS The mean onset time of sensory and motor block of group B and C was significantly faster as compared to the onset in group A. The duration of sensory, motor blockade and duration of analgesia were highest with 1.2 mg of nalbuphine followed by 0.8 and 0.4 mg (P < 0.05). VAS readings were comparable in all the groups. Hemodynamic variability among the three groups was comparable. Incidence of adverse effects was highest in group C when compared with others, although it was statistically insignificant (P > 0.05). CONCLUSIONS Nalbuphine in a dose of 0.8 mg when added to 0.5 % hyperbaric bupivacaine for subarachnoid block in patients undergoing knee joint surgeries provides excellent analgesia, prolonged duration of sensory block and motor block, with minimal adverse effects. KEYWORDS Local Anaesthesia, Opioid, Postoperative Pain, Orthopaedic Surgeries

Comparative study of caudal tramadol and caudal dexmedetomidine as an adjuvant with ropivacaine in paediatric infraumbilical surgeries

Background and Aims: Caudal anaesthesia is one of the most commonly used regional anaesthetic technique in providing peri- and post-operative analgesia. It can serve as the sole anesthetic or can be an adjuvant to general anaesthesia. The aim of this study was to compare the clinical efficacy of the caudal block of 0.25% Ropivacaine with Tramadol or Dexmedetomidine as an adjuvant in paediatric infraumbilical surgeries. Methods: In this prospective, randomised, double-blinded comparative study, sixty children of either gender, in the age group of 1-8 years and scheduled for elective infra umbilical surgeries were randomly divided into two groups of thirty each. Children in Group D received a caudal epidural injection of 1ml/kg 0.25% ropivacaine with 2µg/kg dexmedetomidine while Group T received a caudal epidural injection of 1ml/kg ropivacaine with 2mg/kg tramadol. The primary outcome variable was the duration of time to rescue analgesia. The secondary outcome variables were onset of action, residual motor block, sedation score and adverse effects. Results: Results were statistically analysed using student’s t- test. Mean time of rescue analgesia in group D was 718.00 ± 100.06 min i.e. 11 hours 58 minutes and in group T was 467.33± 68.94 min i.e. 7 hours 47 minutes. (P<0.001). Pain scores measured at regular intervals post operatively were lower in D group as compared to T group. Rescue analgesia requirement was more in group T as compared to group D. Haemodynamic changes and side effects were comparable between the groups Conclusion: Caudal dexmedetomidine with Ropivacaine provides longer duration of post-operative analgesia as compared to caudal Tramadol with Ropivacaine.

Effectiveness of Fentanyl in Facilitating Cannulation of Ampulla of Vater during Endoscopic Retrograde Cholangiopancreatography.

Endoscopic retrograde cholangiopancreatography is carried out under moderate sedation mostly by use of propofol, opioids and benzodizepines. The aim of study is to assess difficulty in cannulation of ampulla of vater with the use of fentanyl. A prospective randomized double blind comparative study was conducted at Bharatpur Hospital from August 2019 to August 2020 among patients undergoing Endoscopic retrograde cholangiopancreatography. Total 100 patients were enrolled in study and were divided in two groups - Group P (propofol and midazolam) and Group FP (propofol, midazolam and fentanyl). Ease of cannulation was determined using Freeman scale. Independent sample t-test was used to compare mean between two groups and Chi Square test was used to compare categorical variables. Mean age (51.36±17.750 years versus 56.74±16.995 years), weight (58.88±8.151 kg versus 57.32±8.431 kg) and gender distribution (14 versus 12 male patients and 36 versus 38 female patients) were comparable in both groups-Group P and Group FP. There were 34 patients in Group P and 37 patients in Group FP with easy cannulation and 16 patients in Group P and 13 patients in Group FP with difficult cannulation, which was comparable (p value=0.509) Conclusions: Cannulation of ampulla of vater is not affected by the use of fentanyl in combination with propofol when compared to propofol alone and can be routinely used during endoscopic retrograde cholangiopancreatography.

English

BACKGROUND The present study was done to compare the cardiovascular responses of etomidate and propofol as induction agents of general anaesthesia under Bispectral index (BIS) guidance and evaluate the effect of intravenous induction agent etomidate and propofol on the variation in heart rate and blood pressure during induction of general anaesthesia. METHODS This is a prospective randomized and double blinded comparative study done in Assam Medical College and Hospital on patients scheduled for elective surgeries under general anaesthesia from June 2019 to May 2020. 80 patients were randomly allocated to group E (etomidate group) and group P (propofol group) of 40 each. All patients were pre-medicated with fentanyl 2 microgram / kg intravenously. Group E received etomidate infusion at 0.05 mg / kg / min and group P received propofol infusion at 0.5 mg / kg / min until Bispectral index value dropped to 60. Patients were intubated with vecuronium 0.1 mg / kg and maintenance of anaesthesia was continued according to institutional protocol. At the end of anaesthetic period, extubation was done after acceptable recovery. Haemodynamic parameters were recorded in both the groups until 10 minutes of induction. RESULTS Statistically significant fall in heart rate was seen in group P than that of group E starting from 3 minutes of induction up to 10 minutes with P value &lt; 0.05 and statistically significant fall in systolic, diastolic, and mean arterial pressure (MAP) was seen in propofol group from that of etomidate group starting from 1 minute of induction up to 10 minutes was seen. CONCLUSIONS We conclude that etomidate is haemodynamically more stable than propofol during the time of induction of anaesthesia. KEY WORDS Etomidate, Propofol, Bispectral Index

Comparative study of magnesium sulphate and dexmedetomidine in the attenuation of pressor response to intubation and on intraoperative haemodynamic parameters in laparoscopic cholecystectomy

Background: Laryngoscopy and intubation incur a reflex sympathetic discharge. Laparoscopic pneumoperitoneum usually causes a hemodynamic response characterized by tachycardia and a rise in blood pressure (BP). The main aim of this study was to compare the beneficial effects of preoperative administration of magnesium sulphate (MgSo4) and dexmedetomidine on the hemodynamic changes of intubation and laparoscopic surgery. Methodology: A randomized, prospective, double-blinded interventional comparative study was conducted on 60 patients undergoing laparoscopic cholecystectomy. Patients were randomized into 2groups, of 30 each to receive magnesium sulphate (50mg/kg(Group A)) or dexmedetomidine(1mcg/kg(Group B)) before induction. Baseline readings of systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), electrocardiography (ECG), and peripheral arterial oxygen saturation (SPO2) were recorded. Results: Among 60 patients, the percentage of patients belonging to the American society of anesthesiologists (ASA) I and II category were in group A (66.67%, 33.33%) and group B (63.33%,36.67%) respectively. Patients of both the groups were comparable on all demographic variables. Conclusion: Magnesium sulphate was better in controlling the stress response of intubation and of laparoscopic surgery. Also, it had extended analgesic effect on immediate post-operative pain which makes it better choice than dexmedetomidine to use as anesthetic adjuvant in general anesthesia in laparoscopic surgery. hemodynamic parameters (except Heart Rate). Visual analog, scale (VAS) was also lower in this group.

Comparative Evaluation of Analgesic Efficacy of Adductor Canal Block Versus Intravenous Diclofenac in Patients Undergoing Knee Arthroscopic Surgery.

Background:Adductor canal block is a new and promising approach for providing postoperative pain relief in arthroscopic knee surgery.Aim:The aim is to compare the postoperative analgesic efficacy of adductor canal block and intravenous (i.v.) diclofenac in patients undergoing knee arthroscopic surgeries.Set and Design:This was a prospective, randomized double-blinded comparative study comprising 60 American Society of Anesthesiologists Physical status Classes I and II patients posted for unilateral knee arthroscopic surgery.Materials and Methods:Patients were randomized into two groups of 30 patients each. Patients were given general anaesthesia with fentanyl, propofol, and vecuronium. Ultrasound (USG) guided adductor canal block with 30 ml of 0.5% ropivacaine was given in Group A patients and patients in Group B received i.v. diclofenac before extubation. After adequate recovery, patients were shifted to postanesthetic care unit. Visual Analogue Scale score was assessed at rest, on standing and on walking 3 m.Statistical Analysis:Student's independent t-test was employed for comparing continuous variables. Chi-square test or Fisher's exact test, whichever is appropriate, was applied for comparing categorical variables.Results:The mean duration of analgesia was longer in Group A as compared to Group B and mean consumption of rescue analgesic was lower in Group A. Both were statistically significant. No significant postoperative complications or local side effects related to the block were noted.Conclusions:Adductor canal block provides a longer duration of postoperative analgesia promotes early mobilization and has a good safety profile in unilateral knee arthroscopic surgeries.

A randomized, double-blinded comparative study of phenylephrine infusion and norepinephrine infusion for the prevention and treatment of spinal anesthesia-induced hypotension in elective and emergency cesarean deliveries

Context and Aims: Among vasopressors used to treat postspinal hypotension (PSH) in cesarean sections (CS), phenylephrine (PE) is the preferred drug at present but reflex bradycardia and thus reduction in cardiac output still pose a concern. Norepinephrine (NE), with its better pharmacological properties, may be a better alternative to overcome this risk. Hence, we did this study intending to compare both the drugs. Materials and Methods: A double-blinded, randomized, controlled trial (RCT) was carried out on 70 patients, 35 in each group-group P (PE) and group N (NE) undergoing CS, to compare and evaluate the efficacy of both drugs for preventing and treating PSH. Patients in Group P and Group N were given intravenous infusion of PE at the rate of 50 μg/min and NE at the rate of 2.5 μg/min, respectively, after the intrathecal injection of bupivacaine. The number of intermittent bolus doses required, heart rate, and mean arterial pressure (MAP) at predefined intervals were noted. Results: The incidence of hypotension calculated from the number of bolus doses required was lower in Group N than in Group P for the initial 15 min (P Conclusion: This study suggests that NE infusion is superior to PE infusion when used in the potency ratio of 20:1, to prevent and treat PSH in CS, with a lesser number of side effects.

Fentanyl versus nalbuphine for intubating conditions during awake fiberoptic bronchoscopy: A randomized double-blind comparative study.

Background and Aims:Patient cooperation, sedation, anxiolysis, and topicalization are important prerequisites for the successful and safe conduct of awake intubation. Because of the pharmacological properties, opioids can facilitate this process. Fentanyl is an opioid agonist and nalbuphine is an agonist-antagonist. This study aims to compare these two opioids for their effect on sedation and intubating conditions during awake fiberoptic intubation.Material and Methods:This randomized double-blind controlled study was conducted on 62 ASA I/II patients of either sex between the age of 20 and 60 years, weight between 40 and 80 kg, with MP class I/II airways requiring general anesthesia with endotracheal intubation. All patients received standard airway topicalization and nebulization. Patients were randomly allocated to one of the two groups according to a computer-generated random number table. Group F (n = 31) received fentanyl 2 μg/kg i.v. and group N (n = 31) received nalbuphine 0.2 mg/kg i.v. over 10 min before intubation. Fiberoptic intubation was attempted and lignocaine spray and propofol boluses were administered as and when required. Hemodynamic responses and intubating conditions were recorded. Repeated measure ANOVA, McNemar test, and Chi-square test or Fischer's exact test were used for data analysis. A P < 0.05 was considered significant.Results:Cough score (P = 0.458), post-intubation score (P = 1.000), and sedation score (P = 1.000) were comparable among the two groups. Hemodynamic responses and propofol and lignocaine requirements were also comparable.Conclusion:Both fentanyl and nalbuphine provide comparable intubating conditions when used before awake fiberoptic intubation with minimal adverse effects on hemodynamic profile.

Postoperative analgesia with epidural butorphanol or tramadol in lower abdominal surgeries– A double blind comparative study

Introduction: Post-operative analgesia in patients undergoing lower abdominal surgery is very essential for immediate postoperative pain relief which can be provided by oral or parenteral medication, epidural analgesia, local blocks etc. The combined spinal–epidural technique (CSE) has become increasingly popular in recent years. The study was designed to evaluate the efficacy of epidural butorphanol and tramadol for postoperative pain relief. After the surgical procedure and regression of spinal analgesia, the epidural catheter can be used to provide postoperative pain relief. Materials and Methods: After permission from hospital ethics committee, study was conducted on 60 patients undergoing lower abdominal surgeries. Combined spinal epidural anaesthesia was planned in all these 60 patients using two segment technique.18 G epidural catheter was placed in L2-L3 space and spinal anaesthesia was given at L3-L4 space using 26 G Quincke’s needle and 0.5% bupivacaine 3ml.Sensory, motor block and hemodynamic parameters were monitored intraoperatively. Postoperatively along with hemodynamic parameters visual analogue score (VAS) was observed and at VAS > 4, study drug (either butorphanol 1mg or tramadol 50mg) was given through epidural catheter. Onset of analgesia, quality of analgesia, duration of analgesia, cardio-respiratory parameters and any side effects were monitored and documented. Statistical Analysis: Data analysis was done using the SPSS (Statistical Package for the Social Science) Version 17 for window. Discussion: Mean onset of analgesia in Butorphanol group (10.03 ± 1.85 min) was significantly faster than Tramadol group (12.17 ± 2.19 min) [Z = 4.07, p Conclusion: Epidural butorphanol provides a rapid, excellent but shorter duration of analgesia when compared to epidural tramadol. Keywords: Butorphanol, Tramadol, Postoperative analgesia, Epidural analgesia.

A Randomized Double Blinded Comparative Study on Efficacy of Intraoperative Dexmedetomedine versus Tramadol Intravenous Infusion in Prevention of Postoperative Shivering Following Spinal Anaesthesia

Introduction: Shivering is a frequent complication reported in 30 to 40% of patients undergoing surgery under regional anaesthesia. It increases oxygen consumption, hypercarbia and minute ventilation. It induces arterial hypoxemia, lactic acidosis, increased intra-ocular pressure, and interferes with patient monitoring and comfort. Most of the studies done in the past have been in the treatment of shivering rather than prevention. This study compared intravenous dexmedetomidine versus intravenous tramadol for prevention of shivering in patients who received spinal anaesthesia for various surgical procedures. Aims and objectives: The aim of this study was to study and compare the efficacy of intravenous infusion of low dose dexmedetomidine (0.25mcg/kg) vs Tramadol (0.5mg/kg) in the prevention of postoperative shivering. Primary objective was prevention of shivering and Secondary objectives were sedation, hemodynamic changes and nausea and vomiting. Materials and Methods: Prospective randomised double blinded comparative study was done on patients scheduled for elective surgery during June 2018-March 2019 in GKNM Hospital, Coimbatore. Patients were included as per criteria. Informed and written consent was obtained and randomized by computer. Group D received IV Dexmedetomidine of 0.25mcg/Kg dose and Group T received IV Tramadol of 0.5mg/kg. Data was collected and analyzed. Patients were evaluated post operatively by the investigator who was blinded to the group assigned. Results: The mean age of the total population was 39.55 ± 11.73 years with male predominance in tramadol group. Dexmedetomedine was more effective in preventing shivering, 16 patients (40%) of group D had shivering compared to 24 patients (60%) of tramadol group. This difference though was not statistically significant, numerically showed that dexmedetomedine was better in prevention of shivering. The tramadol group had early onset of shivering in comparison to Dexmedetomedine group (p&lt;0.05). Dexmedetomedine group had higher grades of sedation and incidence of nausea and vomiting was higher in tramadol group. Conclusion: Dexmedetomedine even at a lower dose is comparatively a more effective drug for prevention of shivering with fewer side effects than tramadol in patients undergoing surgery under spinal anaesthesia.

Prospective randomized double blinded comparative study on the effects of ephedrine and phenylephrine on fetal outcome and their effects on hypotension during elective cesarean section

Introduction: Hemodynamic instability during pregnancy may compromise the blood flow to the uteroplacental bed which may lead fetal acidosis. We compared ephedrine and phenylephrine on fetal outcome and hypotension during elective cesarean section. Aim: To compare the effectiveness of ephedrine versus phenylephrine in fetal outcome and the treatment of fall in blood pressure during subarachnoid block for elective cesarean section. Materials and Methods: Study Design: Prospective, randomized, double blind. Based on inclusion and exclusion criteria 50 patients were selected and divided into two equal groups. All patients were done under subarachnoid block as per routine in our hospital. Group E received Ephedrine 6mg if >20% fall in the heart rate and systolic blood pressure from the baseline. Group P received phenylephrine 20mcg as increments if>20% fall in the heart rate and systolic blood pressure from the baseline. Results: Both the groups were comparable with regard to the fetal outcome (Apgar score and fetal umbilical vein ABG). Nylephrine group showed statistically significant fall in heart rate and systolic blood pressure when compared to the Ephedrine group during the first 20minutes. After 25th minute both the drugs were comparable. Conclusion: Both the drugs were comparable with respect to the fetal outcome and maternal hemodynamics in patients undergoing elective cesarean section under subarachnoid block. Keywords: Ephedrine, Phenylephrine, Hypotension, Subarachnoid block, Cesarean section.

Thrombopoietin Receptor Agonists: Clinical Use and Evaluation of Treatment Efficacy

Idiopathic thrombocytopenic purpura (ITP), or primary immune thrombocytopenia, is an orphan disease associated with thrombocytopenia. One of the most recent and promising approaches to ITP treatment is the use of thrombopoietin receptor agonists (TPO-RAs). The scope of TPO-RA use is expanding rapidly, which stimulates the development of both innovator and generic (or biosimilar) medicines. The aim of the paper was to assess TPO-RA role in ITP treatment, methodological approaches to TPO-RA development, and feasibility of using the platelet count as a pharmacodynamic marker in bioequivalence studies of peptide TPO-RAs in healthy volunteers. Clinical development of new medicines for the treatment of thrombocytopenia includes comparative, parallel-group trials lasting about a year. The standard approach to bioequivalence studies, which is based on the results of comparative pharmacokinetic studies, can be used in marketing authorisation applications for generic non-peptide TPO agonists, while peptide TPO agonists have to comply with specific requirements for biosimilar products. The orphan status of ITP does not affect the development strategy and study design, but it limits the number of patients that could be included into the study. In the absence of valid surrogate biomarkers of efficacy, demonstration of comparable clinical efficacy of the biosimilar and reference drug is usually required in a randomised, parallel, preferably double-blind comparative study. On the other hand, clinical comparability of the biosimilar and reference drug can also be demonstrated in comparative pharmacodynamic studies, if the selected biomarker is a well-established and valid surrogate marker which correlates with patient clinical outcome. Platelet count is a key parameter in both diagnosis of diseases associated with low platelet levels and assessment of treatment efficacy. Therefore, it can be used as a pharmacodynamic marker in bioequivalence studies of biosimilar peptide TPO-RAs. It was concluded that such studies could be performed in healthy volunteers, and not in patients, whose participation in clinical trials is limited due to the orphan status of ITP.

Treatment of established status epilepticus in the elderly - a study protocol for a prospective multicenter double-blind comparative effectiveness trial (ToSEE)

BackgroundStatus epilepticus (SE) is a common neurological emergency condition that especially affects the elderly and old population. Older people with SE frequently have non-convulsive SE (NCSE) and are also at special risk of suffering a poor outcome. The application of benzodiazepines fails to control SE in about one third of the cases. For benzodiazepine refractory SE (BRSE) in elderly, there is little evidence that would justify the choice of one of the commonly used antiepileptic drugs. The present study aims to generate evidence for the treatment of BRSE in this age group.MethodsWe will conduct a prospective, randomized, double-blind comparative effectiveness study in more than twenty hospitals in Germany over a four-year period. Four hundred and seventy-seven elderly patients (≥ 65 years old) diagnosed with BRSE will be allocated by 1:1 randomization to receive either levetiracetam or valproate. All types of SE will be considered. For the diagnosis NCSE a verification by EEG is required. Levetiracetam or valproate will be administered in one single infusion. The primary endpoint is the stable cessation of ictal activity 15 min after the start of infusion persisting for the following 45 min of observation. EEG recording is maintained over the whole observation period, clinical examinations are conducted in predefined intervals. In case of treatment success patients and study staff remain blinded until 60 min after the start of the infusion. Adverse events will be recorded until the end of the study. EEG data will be reviewed by two external independent experts. To obtain data about the further treatment of SE, intrahospital complications and the functional outcome in the short term the study participants will be observed until the day of discharge or day 30 whichever is earliest.DiscussionToSEE is the first study which shall deliver evidence for the SE-therapy in the elderly and old population in a controlled prospective comparator study. By design it also shall collect information about therapy regimes and outcome aspects of this disease.Trial registrationThe trial has been registered at the German Clinical Trials Register on 3 July, 2020 (DRKS00022308, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022308).

Study protocol for SPARED trial: randomised non-inferiority phase III trial comparing dexamethasone on day 1 with dexamethasone on days 1–4, combined with neurokinin-1 receptor antagonist, palonosetron and olanzapine (5 mg) in patients receiving cisplatin-based chemotherapy

IntroductionDexamethasone (DEX) is administered for multiple days to prevent chemotherapy-induced nausea and vomiting for patients receiving highly emetogenic chemotherapy (HEC); however, its notorious side effects have been widely reported. Although...

The Effect of Dutasteride in Peri-Operative Blood Loss During Transurethral Resection of Prostate (Turp)

This prospective double blind comparative study was designed to compare the effect of Dutasteride on the perioperative blood loss in Transurethral Resection of Prostate (TURP).Sixty patients with BPH underwent TURP were divided into 2 groups. Patients belong to the group B (Control) and group A (Experimental). Experimental group patients were given Cap. A (dutasteride 0.5 mg) before two weeks of TURP and group B (control) were given Cap. B (placebo). Postoperative comparison between two groups showed that there were no significant difference between the weight of resected prostatic tissue (control =22.41±6.83 gm, and experimental = 25.38±7.22 gm; p=0.107). Postoperative hemoglobin level of both group (Control group = 10.78±0.64 gm/dL and experimental group = 10.83±.51 gm/dL) revealed no significant difference (p=0.774). The mean hemoglobin loss per gram of prostate tissue in both groups (control = 1.81±0.81 gm/gm and experimental = 1.79±0.88 gm/gm) did not show any statistical difference (p=0.938). In this the study it was found that if the BPH patients are subjected with dutasteride 0.5mg before 2 weeks of TURP, bleeding decrease slightly (Control group = 20.35±7.99 ml/gm and Experimental groups = 17.41±7.70 ml/gm). However, these data of bleeding loss did not show any statistical significance.&#x0D; Bangladesh Journal of Urology, Vol. 22, No. 2, July 2019 p.177-181

A double blinded comparative study between omega 3 fatty acid infusion versus octreotide infusion in acute pancreatitis

Background: Over decades the treatment of acute pancreatitis remains debatable with no common consensus on treatment guidelines, with some workers using octreotide infusion and some workers only relying on fluid therapy and symptomatic management. This double blinded comparative trial between omega 3 fatty acid infusion versus octreotide infusion and its response in cases of acute pancreatitis. Methods: This is a study where a double blinded randomised control trial was undertaken in proven cases of acute pancreatitis and patients were given omega 3 fatty acid infusion and octreotide infusion and the observations were documented and followed upon. 50 cases were given omega 3 fatty acid infusion and other 50 were given octreotide infusion and the clinical response, symptomatic improvement was assessed and compared using BISAP and Marshal scoring systems and lipase levels.Results: Omega 3 fatty acid infusion was found to be highly significant as compared to octreotide in cases of acute pancreatitis in terms of clinical improvement, reduced hospital stay, and SIRS.Conclusions: Omega 3 fatty acid infusion is the future in cases of acute pancreatitis which is cheap and easily available with no side effects and reduces the morbidity and mortality in acute pancreatitis with reduced hospital stay in turn resulting in overall reduced medical expenditure.

Optimal dose of topical tranexamic acid considering efficacy and safety in total knee arthroplasty: a randomized controlled study.

This study aimed to evaluate the optimal dosage of topical tranexamic acid (TXA) considering the efficacy and safety for controlling bleeding after total knee arthroplasty (TKA). This prospective randomized double-blinded placebo-controlled comparative study included 325 patients scheduled to undergo TKA, who were randomly assigned to five groups based on the topical TXA injection (n = 65 per group): control; group 1, 0.5g TXA; group 2, 1.0g TXA; group 3, 2.0g TXA; and group 4, 3.0g TXA. The primary outcome was decrease in postoperative hemoglobin levels. The secondary outcomes were blood loss calculated using Good's method, drainage volume, frequency of transfusion, and range of motion (ROM). Plasma TXA levels and complications were also evaluated. Significant differences were noted in the decrease in hemoglobin levels between the control group and groups 2 (p = 0.0027), 3 (p = 0.005), and 4 (p = 0.001). No significant differences were shown among the experimental groups. Significant differences in total blood loss and frequency of transfusion were noted between the control group and groups 2 (p = 0.004, 0.002, respectively), 3 (p = 0.007, 0.001, respectively), and 4 (p = 0.001, 0.009, respectively) without showing significant differences among the experimental groups. With respect to drainage volume, no significant differences were observed among the groups. The serum TXA levels increased proportionally with the applied dose of topical TXA immediately and at 3 and 6h postoperatively. Symptomatic deep vein thrombosis or pulmonary embolism was not observed in any group. Other complications related to TXA administration were not detected. Topical application of 1.0g or more of TXA shows significant bleeding control without a dose-response relationship. Blood TXA levels increase with the TXA dose following topical TXA application. Therefore, to prevent overdosing and reduce potential complications with ensuring the effectiveness, 1.0g of TXA is recommended as a topical application. I.

Comparison of efficacy between combined periarticular and incisional injections versus periarticular injection alone of bupivacaine for pain control after total knee arthroplasty: A prospective randomized controlled trial.

The aim of this study was to compare the efficacy of combined periarticular and incisional injections versus periarticular injection alone of bupivacaine in reducing post-operative pain after total knee arthroplasty (TKA). In this prospective, randomized, double-blind comparative study, 90 patients with primary osteoarthritis who underwent TKA were enrolled. The patients were then randomly divided into 3 groups (30 in each): group 1, without injection; group 2, with periarticular injection of 20 mL 0.5% bupivacaine hydrogen chloride (HCl) (100 mg) after implantation; and group 3, periarticular injection of 20 mL 0.5% bupivacaine HCl (100 mg) after implantation and incisional injection of 10 mL 0.5% bupivacaine HCl (50 mg) before wound closure. Post-operative pain levels were measured using a 100-mm visual analogue scale (VAS) (0 mm: no pain and 100 mm: worst pain) at 30 min and 1, 2, 4, and 6 h, post-operatively. The mean VAS score in group 3 (the combined group-periarticular and incisional injections) within the first 4 h was lower than that in group 1 and group 2 (p<0.001). The mean VAS scores at the first 30 min were 65.21±9.46 in group 1, 51.86±5.96 in group 2, and 29.33±8.55 in group 3 (p<0.001). The mean VAS scores at the first 1 h were 64.43±9.32 in group 1, 47.26±4.77 in group 2, and 31.66±7.37 in group 3 (p<0.001). The mean scores at the 2 h were 61.46±8.62 in group 1, 48.33±4.66 in group 2, and 30.83±6.76 in group 3 (p<0.001). The mean scores at the 4 h were 64.72±8.91 in group 1, 47.53±4.35 in group 2, and 34.36±6.64 in group 3 (p<0.001). The differences were not significant at 6 h between group 2 (44.91±4.12) and group 3 (41.83±6.71) (p>0.001). However, the values were significantly lower than those of the control group (63.56±9.73) (p<0.001). In addition, VAS scores at all follow-up times were significantly higher in the control group compared with the other groups (p<0.001). Evidence from this study revealed that the combined injection of bupivacaine is more effective than its periarticular injection alone and provides effective post-operative pain management after TKA. Level I, Therapeutic study.