Double-blind Comparative Study Research Articles

Role of stress in dynamic single-photon emission computed tomography with myocardial perfusion reserve determination in assessing the severity of coronary artery stenosis

Aim. To assess the role of global and selected scintigraphic scores of myocardial perfusion, blood flow and reserve in the anatomical and functional significance of coronary artery (CA) stenosis.Material and methods. The double-blind comparative study included 23 patients (mean age 61,2±6,8 years, 12 (52%) women, 11 (48%) men). All patients underwent stress dynamic single-photon emission computed tomography (SPECT) with adenosine triphosphate (ATP) (140 µg/kg/min in 6 minutes). Myocardial perfusion disorders were assessed by a semi-quantitative method, the total Summed Stress Score (SSS), the Summed Rest Score (SRS), and the Summed Difference Score (SDS) were determined. Global (g) and regional (r) myocardial perfusion (MP) were evaluated; myocardial perfusion reserve (MPR) was calculated as the ratio of MP at stress and at rest. Coronary angiography (CAG) was performed within 1 week after SPECT, the amount of CA narrowing was evaluated by diameter. Stenoses >50% were considered anatomically significant. The assessment of the fractional flow reserve (FFR) was performed by the ratio of the mean intracoronary pressure at the CA ostia to the pressure distal to the stenosis at the ATP infusion peak. FFR ≤0,80 was considered a sign of hemodynamically significant stenosis. Results. Neither regional nor global scintigraphic scores reflecting myocardial perfusion showed statistical significance as markers of CA stenosis >50%. Among perfusion markers, only SSSg (>4) showed good sensitivity and specificity in the diagnosis of hemodynamically significant (FFR ≤0,80) stenoses (AUC 0,76; p=0,002; sensitivity 81,8%, specificity 83,3%). The following regional flow scores allowed identification of hemodynamically significant CA: stress MPr ≤0,54 ml/min/g (AUC 0,8; p=0,0003; sensitivity 57%, specificity 92%) and MPR ≤1,5 (AUC 0,86; p< 0,0001; sensitivity 71,4%, specificity 92,8%).Conclusion. It is proved that global and regional scintigraphic scores of MP and MPR are sensitive and specific markers of hemodynamically significant (FFR ≤0,80) coronary stenosis. It can be more useful for localization diagnosis of the lesion than standard SPECT.

Comparison of Triamcinolone Versus Platelet Rich Plasma Injection for Improving Trismus in Oral Submucous Fibrosis

Objective: To compare the effect of Triamcinolone versus Platelet Rich Plasma (PRP) injection intraorally for improving trismus in Oral Submucous Fibrosis (OSMF). Study Design and setting: Randomized double-blind comparative study, conducted at ENT department of PNS Shifa Hospital, Karachi from 1st June 2015 to 30th June 2016. Methodology: Eighty patients with trismus due to oral submucous fibrosis were divided randomly into two groups, ‘A’ and ‘B’ of 40 patients each. In Group A, Inj. Triamcinolone 40mg (1 ml) was injected into the sub-mucosal plane in the retro-molar trigone area and into the fibrous bands along the soft palate on multiple sites, weekly for 6 weeks. In group B Inj. PRP 1ml weekly was administered for 6 weeks along the same site. Vernier calipers were used to precisely measure the Maximum Interincisal Distance (MIID) in cms before and after the treatment. Result: There was a male preponderance in the study group with a male to female ratio of 5.1:1. In group ‘A’ mean pretreatment MIID was 2.3±0.7 cms, while in group ‘B’, it was 2.2± 0.5 cms. After completion of 6 weeks treatment the mean MIID improved in group ‘A’ to 3.08 ± 0.8cms, and in group ‘B’ to 3.22± 0.5cms. The mean improvement in MIID in group ‘A’ was 0.783± 0.25cms compared to 1.01± 0.05 cms in group ‘B’ (p < 0.05). Conclusion: Intraoral injection of PRP is more effective than Triamcinolone in improving trismus due to OSMF

Combined pulsed and thermal radiofrequency versus thermal radiofrequency alone in the treatment of recurrent trigeminal neuralgia after microvascular decompression: A double blinded comparative study.

Recurrent trigeminal neuralgia (RTN) is a common clinical problem and pain recurs in many patients after microvascular decompression (MVD). We evaluated the effect of adding pulsed radiofrequency to radiofrequency thermocoagulation at 60°C compared to radiofrequency thermocoagulation at 70°C alone in the treatment of recurrent trigeminal neuralgia after microvascular decompression. 40 patients with recurrent trigeminal neuralgia after microvascular decompression were randomly divided into two equal groups. Group A: received prolonged duration of pulsed radiofrequency followed by less destructive thermocoagulation, while group B: received sole thermocoagulation. Then patients followed up for 2years to evaluate the success rate by the Barrow Neurological Institute Pain Intensity (BNI) Scale, complications, and the need to medical treatment. The success rate was 100% in both groups at discharge (BNI<III). It was 83.3% and 78.7% after 6months, 77.8% and 68.4% after 12month, 72.2% and 68.4% after 18months and 66.7% and 63.1% after 24months in group A and B, respectively (p>.05). In group A 88.9% of patients stopped tegretol treatment after the procedure compared to 84.2% in group B (p=.32). 88.9% compared to 89.5% % in group A and B, respectively, did not use tricyclic antidepressant (p=.61). The overall complications in group A was 5.61%, while it was 36.8% in group B (p=.025). Combined pulsed and thermal radiofrequency can significantly reduce the incidence of the side effects/complications with similar success rate than using thermal radiofrequency alone in treatment of recurrent trigeminal neuralgia after microvascular decompression.

Magnesium Sulfate versus Fentanyl as Adjuvant to Epidural Levobupivacaine in Surgeries below Umbilicus

Background: Epidural anesthesia is performed to provide anesthesia for surgical procedures carried on lower abdomen, pelvis, and lower limbs. It offers superior pain relief and early mobilization especially when local anesthetic is combined with an adjuvant. Noxious impulses from damaged tissue evoke long lasting alterations in the central nervous system. Objective: The aim of the current study was to evaluate and compare between the effectiveness of adding magnesium sulphate versus addition of fentanyl to epidural levobupivacaine in onset of sensory and motor block, duration of analgesia , quality of block , intraoperative hemodynamics, post-operative pain control and post-operative side effects. Patients and Methods: The present study is a prospective randomized double blind controlled comparative study conducted for patients scheduled to undergo elective surgeries below umbilicus in Al-Azhar University Hospital in Assiut. After obtaining Institutional Ethics Committee approval and written informed consent, 90 patients ASA I/II were enrolled into the study. Results: this study demonstrated that magnesium, and fentanyl are effective as useful adjuvants to local anesthetic for epidural anesthesia. Magnesium sulphate is associated with a shorter onset of action of the epidural block with less nausea, vomiting and pruritis incidence, fentanyl have a prolonged duration but more incidence for those side effects. Conclusion: It could be concluded that magnesium sulfate and fentanyl are good adjuvants to local anesthetics when given epidurally, fentanyl provides more duration of analgesia but with more incidence of nausea vomiting and pruritis when compared to magnesium sulfate, but magnesium sulfate show more incidence of pain with injection.

Magnesium Sulfate versus Fentanyl as Adjuvant to Epidural Levobupivacaine in Surgeries below Umbilicus

Background: Epidural anesthesia is performed to provide anesthesia for surgical procedures carried on lower abdomen, pelvis, and lower limbs. It offers superior pain relief and early mobilization especially when local anesthetic is combined with an adjuvant. Noxious impulses from damaged tissue evoke long lasting alterations in the central nervous system. Objective: The aim of the current study was to evaluate and compare between the effectiveness of adding magnesium sulphate versus addition of fentanyl to epidural levobupivacaine in onset of sensory and motor block, duration of analgesia , quality of block , intraoperative hemodynamics, post-operative pain control and post-operative side effects. Patients and Methods: The present study is a prospective randomized double blind controlled comparative study conducted for patients scheduled to undergo elective surgeries below umbilicus in Al-Azhar University Hospital in Assiut. After obtaining Institutional Ethics Committee approval and written informed consent, 90 patients ASA I/II were enrolled into the study. Results: this study demonstrated that magnesium, and fentanyl are effective as useful adjuvants to local anesthetic for epidural anesthesia. Magnesium sulphate is associated with a shorter onset of action of the epidural block with less nausea, vomiting and pruritis incidence, fentanyl have a prolonged duration but more incidence for those side effects. Conclusion: It could be concluded that magnesium sulfate and fentanyl are good adjuvants to local anesthetics when given epidurally, fentanyl provides more duration of analgesia but with more incidence of nausea vomiting and pruritis when compared to magnesium sulfate, but magnesium sulfate show more incidence of pain with injection.

A Randomized Double-blind Comparative Study of the Efficacy of Helicobacter pylori Eradication Therapy and Motilitone® for Functional Dyspepsia

A Randomized Double-blind Comparative Study of the Efficacy of Helicobacter pylori Eradication Therapy and Motilitone® for Functional Dyspepsia

Comparative Double Blind Study for the Effect of Dexmedetomidine During Sedation of Obstructive Sleep Apnea Obese Patients for Upper Gastro Endoscopic Procedures

Comparative Double Blind Study for the Effect of Dexmedetomidine During Sedation of Obstructive Sleep Apnea Obese Patients for Upper Gastro Endoscopic Procedures

Comparative Study of Propofol and Etomidate on the Haemodynamic Effects During Induction and Endotracheal Intubation

Introduction: While most intravenous induction agents decrease arterial blood pressure, laryngoscopy and endotracheal intubation increase the heart rate and blood pressure. Propofol causes a decrease in systemic blood pressure whereas etomidate has minimal effects on the cardiovascular system. This study aims to evaluate and compare the hemodynamic effects of propofol and etomidate during induction and endotracheal intubation.&#x0D; Methods: 62 ASA I and II patients, 20-60 years of age, scheduled for elective surgery were enrolled in this prospective, randomised and double blind comparative study. Group A received inj. Propofol (2 mg/kg) and group B received inj. Etomidate (0.3 mg/kg), as induction agents. Heart rate, systolic blood pressure, diastolic blood pressure and mean arterial blood pressure were recorded after induction and after intubation at one, three, five and ten minutes and intergroup comparisons were made.&#x0D; Results: After induction the decrease in systolic, diastolic and the mean arterial pressures were more in group A compared to group B (p = 0.003, 0.004 and 0.002). After 1 minute of intubation all haemodynamic parameters increased from the baseline with no significant differences between the two groups (p &gt;0.05). At three minutes the decrease in heart rate, diastolic blood pressure and mean arterial pressure was more in group A than group B with p values of 0.001, 0.002 and 0.05, however systolic blood pressures showed no significant difference (p = 0.144). The decrease in blood pressures showed significant difference between the two groups (p &lt;0.05) at five and ten minutes but the decrease in heart rate remained significant only at five minutes of intubation (p = 0.001).&#x0D; Conclusions: Propofol and etomidate are both effective in preventing the haemodynamic changes due to induction and endotracheal intubation, with etomidate providing more haemodynamic stability.

Can Eradication of Helicobacter pylori Improve the Symptoms of Functional Dyspepsia?

See the article "A Randomized Double-blind Comparative Study of the Efficacy of Helicobacter pylori Eradication Therapy and Motilitone® for Functional Dyspepsia" on page 106.

A Randomized Double-blind Comparative Study of the Efficacy of Helicobacter pylori Eradication Therapy and Motilitone® for Functional Dyspepsia

A Randomized Double-blind Comparative Study of the Efficacy of Helicobacter pylori Eradication Therapy and Motilitone® for Functional Dyspepsia

Oral Pregabalin vs Oral Hormone in An Exceedingly Attenuation of Hemodyanamic Response to Laryngoscopy Insertion, Extubation in Patients Undergoing Laparoscopic Cholecystectomy

Background: Premedication in the form of vasodilators, adreno receptor blockers, calcium channel blockers and opioids were used earlier to attenuate these responses, with variable results. This study will be conducted to evaluate &amp; compare efficacy of oral pregabalin &amp; oral melatonin in attenuation of haemodynamic responses during laryngoscopy, intubation &amp; extubation in laparoscopic cholecystectomy. Subjects and Methods: This is a Prospective randomized double blind comparative study done on 60 Patients undergoing laparoscopic cholecystectomy in Department of Anesthesiology, Saraswathi Institute of Medical Sciences, Anwarpur, Hapur, Uttar Pradesh, India. All patients were explained about the anaesthesia technique and written informed consent taken. Group P - (30 patients) oral pregabalin 150mg, 120 min before surgery and Group M- (30 patients) oral melatonin tablets 6 mg (two tablets of 3 mg), 120 min before surgery. Pre-anaesthetic evaluation was done a day prior. Patients to be kept NPO 8 hours prior to surgery. Results: Our study showed that the mean age of patients was 36.50±12.01 years in group P and 34.70±14.82 years in group M, but statistically non-significant (P=0.6073). The heart rate, SBP, DBP &amp; Mean arterial pressure was statistical non-significant. The complications occurred more in group P as compare to group M. The bradycardia, headache was more common complications in both groups. Conclusion: We concluded that both the drugs can be used as an effective premedicant to attenuate the sympathetic response to laryngoscopy and tracheal intubation without much side effects and the added advantage of intraoperative and postoperative analgesia.

Dexmedetomidine/propofol versus dexmedetomidine/ketamine versus dexmedetomidine as a sole agent for pediatric sedation during MRI

BackgroundPropofol use in MRI procedures is growing worldwide especially for infants and children. Propofol causes unintended deep sedation and respiratory depression. The safety and efficacy of dexmedetomidine–propofol versus ketamine–dexmedetomidine versus dexmedetomidine alone as a based sedation regimen in specific age range of children is the study concern.ObjectiveThe aim of this study is to compare the efficacy of dexmedetomidine/propofol mixture, dexmedetomidine/ketamine, and dexmedetomidine alone for pediatric MRI sedation.Patients and methodsNinty infants and children whose body weight is more than 10 kg were enrolled in a double-blind comparative study and assigned into three equal groups for sedation, group (DK) dexmedetomidine/ ketamine, group (DP) dexmedetomidine/propofol, and group (D) dexmedetomididne alone. All patients were given premedication in the form of oral midazolam 0.5 mg/kg 30 min before the procedure. Sedation was according to group: Group (DK) received ketamine 1.5 mg /kg intravenous bolus as a loading dose and maintenance dose done by dexmedetomidine infusion with a concentration of 0.004 mg/ml and infusion rate of 1 μg/kg/h for the first 10 min then reduced infusion dose to be in between 0.6 and 1 μg/kg/h to keep the patient sedated to a Ramsay sedation score more than 4. Group (DP) received propofol 1.5 mg/kg intravenous bolus as a loading dose, then maintenance dose infusion was a mixture of dexmedetomidine with a concentration of 0.004 mg/ml and propofol 4 mg/ml; this combination is compatible (Trissel et al., 2002; Cayo, 2013). This combination will be started by a loading dose of 1 μg/kg/h for the first 10 min then 0.6 to 1 μg/kg/h, sedated with a Ramsay sedation score of more than 4. Group (D) received dexmedetomidine with a dose of 2–3 μg/kg/h as loading for 10 min then 0.6 to 1 μg/kg/h to keep the patient sedated with a Ramsay sedation score of more than 4.ResultsThere was a significant difference between the DP group induction recovery time, hemodynamics, and Ramsey sedation score up to 5 min after the induction to the other two groups, and there was a significant difference between the DK group to the other two groups concerning emergence phenomena (agitation, altered perception, hallucination) and sedation failure.ConclusionThe combination of dexmedetomidine to propofol with a low dose for sedation during MRI gives better induction + recovery time, improves hemodynamics, and decreases incidence of emergence phenomena and sedation failure.

The efficacy of glycolic acid, salicylic acid, gluconolactone, and licochalcone A combined with 0.1% adapalene vs adapalene monotherapy in mild-to-moderate acne vulgaris: a double-blinded within-person comparative study.

BackgroundAcne vulgaris is a common and chronic disease that impacts on physical and psychological perceptions. Cosmeceutical products are widely used as adjunct therapy to standard treatments.ObjectiveTo evaluate the efficacy of cosmeceutical products comprising glycolic acid, salicylic acid, gluconolactone, and licochalcone A as adjunct therapy to adapalene in mild-to-moderate acne vulgaris.Materials and methodsA 28-day, double-blind, within-person comparative study was conducted with a total of 25 subjects. Each participant received two products, consisting of (1) a cosmeceutical product mixed with 0.1% adapalene, and (2) 0.1% adapalene, and was asked to apply them separately on each hemi-side once nightly for 28 days. The number of acne lesions, severity of acne vulgaris, physician’s and patient’s global assessment of acne severity, visual analog scale of radiance, skin biophysics, safety assessment, and VISIA® camera system were evaluated. The primary efficacy outcome was to compare the reduction of inflammatory lesions between two treatments at day 7 by using non-inferiority comparison.ResultsThe mean differences of inflammatory lesions reduction at day 7 between the two groups was 0.391 (90% CI = 0.253–0.530). The differences between two groups fell within our acceptable margin for the 90% CI. The spot score from VISIA® showed higher statistically significant improvement in the combination side.ConclusionThe results showed no hindrance of using a cosmeceutical combined with standard treatment. Nevertheless, this cosmeceutical product showed some benefits in reducing complications from acne.Clinical trial registrationThai Clinical Trials Registry (primary site), no. TCTR20171031005.

A Comparative study of intra-articular injection of steroid versus prolotherapy for pain relief in patients of osteoarthritis knee

Background: Osteoarthritis (OA) is a major source of disability owing to pain and loss of function. Intra-articular (IA) injection is the last nonoperative modality that can be used. We compared the efficacy of IA steroids and prolotherapy for relieving pain in patients of knee OA. Materials and Methods: We conducted a randomized, double-blind comparative study on 56 patients of OA knee assigned into two groups: steroid and prolotherapy group. Injections were given at 0, 1, and 2 months. During 6-month follow-up, patients were evaluated for pain relief by visual analog scale (VAS) score, quality of life (QOL) score, and requirement of rescue analgesic. Results: At baseline, mean VAS score of prolotherapy group (6.71 ± 0.94) and steroid group (6.36 ± 0.99) were comparable (P = 0.166). After 6 months, mean VAS score in prolotherapy group was 4.07 ± 1.44 as compared to 3.14 ± 0.89 in steroid group, and difference was statistically significant (P = 0.009). Furthermore, at baseline, QOL score of prolotherapy group (81.75 ± 4.69) and steroid group (79.29 ± 3.89) were comparable. After 6 months, it was found to be 70.43 ± 4.97 in prolotherapy group and 67.36 ± 2.74 in steroid group, the difference being highly significant (P = 0.007). Number of patients requiring rescue analgesia (P = 0.280) and the mean number of doses of rescue analgesic consumed (P = 0.538), both were slightly higher in prolotherapy group. Conclusion: Intra-articular steroid was better than prolotherapy in relieving pain of OA knee.

Pharmacotherapy of psychomotor developmental delay in 6-12 months preterm infants with hypoxic-ischemic encephalopathy (the double-blind comparative multicenter placebo-controlled study)

To evaluate the efficacy and safety of hopantenic acid (Pantogam) in the complex treatment of prematurely born infants, aged 6-12 months, with psychomotor developmental delay due to hypoxic-ischemic encephalopathy. Eighty-seven patients were randomized into two groups: 44 received standardized treatment and pantogam for two months, 43 standardized treatment and placebo. Pantogam (syrup 100 mg/ml) or placebo were prescribed orally 15-30 minutes after feeding, twice a day, in a daily dosage of 30-50 mg/kg body weight. The assessment of psychomotor development from birth to two years was performed with the Griffiths Mental Development Scales (GMDS-ER) twice (before and after completion of therapy). The response to two month therapy determined as the reduction of developmental delay for more than 6% of the initial GMDS-ER general quotient (GQ) score was significantly better in the group I after pantogam treatment (63.6% of patients) compared to group II (36.4%, p=0.021). Group I demonstrated the significant decrease of the developmental delay in two domains ('Personal-Social' and 'Performance') and a trend to overcome the delay in three other domains: 'Locomotor', 'Hearing and Speech', 'Eye and Hand Coordination'. The improvement after pantogam treatment was more obvious in the subgroup of infants born late preterm (gestational age 34-36 weeks) compared to infants born moderate preterm (gestational age 32-33 weeks). The favorable safety profile of pantogam was confirmed, comparable to that of placebo. Pantogam is efficient and safe medication in the complex treatment of psychomotor developmental delay in preterm infants, aged 6-12 months.

Attenuation of Cardiovascular response to Intubation: A double blind Comparative study of Esmolol and Lignocaine with hemodynamic response

Attenuation of Cardiovascular response to Intubation: A double blind Comparative study of Esmolol and Lignocaine with hemodynamic response

A randomized double blind comparative study of analgesic efficacy of different doses of intrathecal nalbuphine in patients undergoing abdominal hysterectomy

A randomized double blind comparative study of analgesic efficacy of different doses of intrathecal nalbuphine in patients undergoing abdominal hysterectomy

The effects of adding dexamethasone to epidural bupivacaine for lower limb orthopedic surgery

Introduction Dexamethasone when given epidurally with local anesthetics is known to reduce postoperative pain and postoperative analgesic consumption in several types of surgical procedures. Objective The objective of this study was to evaluate the effect of epidural dexamethasone on postoperative analgesia in patients who were undergoing lower limb orthopedic surgery. Patients and methods It is a prospective, randomized, double-blinded comparative study carried out in Assiut University Hospital, Egypt. It included 50 patients divided into two equal groups (25 in each), who underwent lower limb orthopedic surgery. The saline group: who received 15 ml epidural plain bupivacaine (0.5%)+2 ml normal saline (BS) and the dexamethasone group: who received 15 ml epidural plain bupivacaine (0.5%)+8 mg dexamethasone (2 ml) (BD). Postoperatively, when the pain score of at least 4, the rescue analgesia was given in the form of fentanyl and bupivacaine epidurally and paracetamol (perfalgan) 1 g was given routinely for all patients intravenous drip/8 h. Pain was evaluated by visual analog scale every 4 h in the postoperative 24 h. Time to first request for analgesia and total dose of rescue analgesia (epidural fentanyl/bupivacaine) in the first, 24 h postoperative was recorded. Results Dexamethasone significantly reduced the first, 24 h postoperative pain score (visual analog scale), and postoperative epidural fentanyl consumption (70.00 vs. 43.40 μg) in the first, 24 h postoperative. Dexamethasone also significantly prolonged the time to first request for analgesia (3.38 ± 0.072 vs. 15.24 ± 2.03 h). Conclusion Epidural dexamethasone with bupivacaine offers favorable effects on postoperative analgesia in lower limb orthopedic surgery.

Clinical efficacy of isobaric ropivacaine alone, ropivacaine-fentanyl and ropivacaine-dexmedetomidine in spinal anaesthesia for vaginal hysterectomy: A prospective randomized double-blind comparative study

Clinical efficacy of isobaric ropivacaine alone, ropivacaine-fentanyl and ropivacaine-dexmedetomidine in spinal anaesthesia for vaginal hysterectomy: A prospective randomized double-blind comparative study

Effect of Clonidine and Dexmedetomidine on Haemodynamic and Recovery Responses During Tracheal Extubation: A Randomised DoubleBlind Comparative Study

Effect of Clonidine and Dexmedetomidine on Haemodynamic and Recovery Responses During Tracheal Extubation: A Randomised DoubleBlind Comparative Study