Efficacy of low-concentration nitrous oxide gas anesthesia in routine cataract microsurgeries.
WHAT IS KNOWN : •Low-concentration nitrous oxide (LCNO) has been used in dentistry and some ophthalmic procedures and is believed to reduce anxiety and discomfort. •Evidence for its sedative effect in cataract microsurgery has largely relied on subjective patient reports rather than objective monitoring. • This study provides objective evidence, using bispectral index (BIS) monitoring, that LCNO induces mild sedation during routine cataract microsurgery. •LCNO significantly reduced the BIS values during surgery without causing clinically relevant changes in the vital signs or adverse events, supporting its safety and practicality for outpatient cataract surgery.
- Research Article
20
- 10.1213/ane.0000000000004345
- Oct 1, 2019
- Anesthesia & Analgesia
Monitoring of High- and Intermediate-Risk Surgical Patients.
- Research Article
- 10.3760/cma.j.issn.1673-4378.2013.12.005
- Dec 15, 2013
- International Journal of Anesthesiology and Resuscitation
Objective To study the effect of dexmedetomidine(DEX) and morphine hydrochloride on respiratory mechanics in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) undergoing mechanical ventilation.Methods Forty patients of AECOPD with respiratory failure undergoing mechanically ventilated were randomly divided into two groups (n=20).The control group were treated with morphine for sedation while the experimental group with DEX.APACHE Ⅱ score,bispectral index (BIS) score,ramsay score were recorded.Respiratory mechanical parameters after sedation,and changes in vital signs as well as blood gas were compared before and after sedation.Results Compared with the control group,the mean arterial pressure (MAP) and pulse in the experimental group were decreased after sedation[(80±3) mm Hg vs (75±4) mm Hg(1 mm Hg=0.133 kPa),(90±3) bpm vs (79±3) bpm](P<0.01).The mean airway pressure(Paw) and plateau pressure(Pplat) were significantly downregulated in experimental group [(7.5±0.7) cm H2O vs (6.2±0.6) cm H2O (1 cm H2O=0.098 kPa),(19.8±1.7) cm H2O vs (18.0±1.1) cm H2O] (P<0.05).peak esophageal pressure (PPEAK ES) and the peak esophageal manometry reference esophagus pressure difference (dPES) was increased [(-3.4±0.7) cm H2O vs (-5.4±1.0) cm H2O,(-6.9±1.0) cm H2O vs (-9.8±1.3) cm H2O] (P<0.01).There were no significant difference between the two groups in folding screen the end of the suction gas during transpulmonary pressure (Ptp Plat) and pulmonary static compliance (Cst)[(25.5±2.3) cm H2O vs (26.0±2.6) cm H2O,(20.5±1.9)em H2O vs (20.1±1.2) cm H2O].The airway resistance (Raw)[(20.3±0.9) cm H2O·L-1·s-1 vs (15.6±1.4) cm H2O·L1·s-1](P<0.01)and mechanical work of breathing (WOBv)[(0.49±0.10) j/L vs (0.43±0.06) j/L](P<0.05) were increased.The patient work of breathing (WOBp) was significantly increased [(0.11 ±0.02)j/L vs (0.16±0.04)j/L] (P<0.01).The time of mechanical ventilation and the intensive care unit (ICU)staying time were reduced [(76±5) h vs (64±3) h、(6.0±1.5) d vs (4.6±0.9) d](P<0.05).Conclusions DEX increased the sedative effect and lung compliance,and decreased Raw in patients undergoing mechanical ventilation compared with morphine.DEX would also unload respiratory muscle oxygen consumption estimated by reducing the inspiratory load and work of breathing. Key words: Dexmedetomidine; Chronic obstructive pulmonary disease; Mechanical ventilation; Respiratory mechanics
- Discussion
12
- 10.1053/cr.2000.7978
- Aug 1, 2000
- Journal of Cardiothoracic and Vascular Anesthesia
Ketamine interferes with bispectral index monitoring in cardiac patients undergoing cardiopulmonary bypass
- Research Article
15
- 10.1111/anae.12172
- Mar 22, 2013
- Anaesthesia
We performed a randomised, crossover study to investigate the effects of intravenous sedation on grip strength and bite force. Twenty male volunteers received a bolus intravenous injection of midazolam (0.02 mg.kg(-1)) together with a 30-min propofol infusion designed to achieve an effect-site concentration of 1.0 μg.ml(-1). Observed variables included bispectral index, observer's assessment of alertness/sedation, correct answer rate of Stroop colour-word test, grip strength and bite force. Grip strength decreased from a median (IQR [range]) of 483 (443-517 [380-586]) N to 358 (280-405 [108-580]) N (p < 0.001) during sedation and recovered following flumazenil administration, while bite force increased from 818 (593-1026 [405-1406]) N to 1377 (1243-1585 [836-2357]) N (p < 0.001) during sedation. Although bite force gradually returned to baseline following flumazenil administration, it remained increased throughout the experimental period. We conclude that bite force increased during intravenous sedation and that this may have clinical implications.
- Research Article
25
- 10.4103/2152-7806.141890
- Jan 1, 2014
- Surgical Neurology International
Background:Bispectral index (BIS) monitoring in multiple trauma patients has become a common practice in monitoring the sedation levels. We aimed to assess the utility of BIS in the trauma intensive care unit (ICU).Methods:A prospective observational study was conducted in the trauma ICU at Hamad General Hospital in Qatar between 2011 and 2012. Patients were divided in two groups: Group I (without BIS monitoring) and Group II (with BIS monitoring). The depth of sedation was clinically evaluated with Ramsey Sedation Scale, changes in vital signs and Glasgow Coma Scale (GCS) level. Use of sedatives, analgesics, and muscle relaxants were also recorded. Data were compared using Chi-square and Student t-tests.Results:A total of 110 mechanically ventilated trauma patients were enrolled with a mean age of 36 ± 14 years. The rate of head injury was greater in Group I when compared with Group II (94% vs. 81%, P = 0.04). In comparison to Group I, patients in Group II had lower GCS and higher mean Injury Severity Score (ISS) (6.3 ± 2.5 vs. 7.4 ± 2.7 and 25.5 ± 8.5 vs. 21.2 ± 4.7, respectively, P = 0.03). The used midazolam dose was less in Group II in comparison to Group I (5.2 ± 2.3 vs. 6.1 ± 2.1, P = 0.03). Also, fentanyl dose was less in Group II (152 ± 58 vs. 187 ± 59, P = 0.004). The rate of agitation, failure of extubation and tracheostomy in Group II were lower than those in Group I, P = 0.001. The length of stay for patients Group I was longer (14.6 ± 7.1 vs. 10.2 ± 5.9 days) in comparison to group II, P = 0.001.Conclusion:Management of multiple trauma patients in the trauma ICU with BIS monitoring was found to be associated with better outcomes. BIS monitoring is a guide for adjusting the dosage of sedative agents. It can also minimize agitation, failure of extubation, and length of stay in ICU.
- Research Article
22
- 10.1053/j.jvca.2004.07.027
- Oct 1, 2004
- Journal of Cardiothoracic and Vascular Anesthesia
Cerebral function monitors during pediatric cardiac surgery: Can they make a difference?
- Research Article
1
- 10.35975/apic.v27i6.2234
- Dec 12, 2023
- Anaesthesia, Pain & Intensive Care
Background & Objective: Sedation is often required in outpatient surgical procedures, performed under local analgesia, to allay the anxiety of the patient, which may lead to involuntary movements of the patient, thus interfering in the smooth course of the surgery. Various sedative drugs have been used by the anesthetists. We compared the effects of mild sedation techniques induced by remifentanil combined with propofol and esketamine combined with propofol on the cardiopulmonary indices of intraoperative patients, and to explore the application of mild sedation techniques in oral outpatient surgery. Methodology: A total of 62 patients undergoing oral surgery were randomly divided into a control group (31 cases, receiving remifentanil combined with propofol) and an observation group (31 cases, receiving esketamine combined with propofol). The vital signs of the patients were monitored at five time points: admission (T0), anesthesia induction (T1), local anesthesia (T2), the beginning of surgery (T3), and the end of surgery (T4), including heart rate (HR), mean arterial pressure(MAP), bispectral index (BIS), respiratory rate, and oxygen saturation(SPO2). Postoperative memory of each step was recorded, and the sedative effect was evaluated by physician and patient using the visual analogue scale (VAS). Results: During surgery, 6 patients in the control group had SpO2 < 90%, and 8 patients experienced coughing or tongue fall, while 1 patient in the observation group had a transient increase in blood pressure. After intravenous administration, all patients had a decrease in HR, and the decrease in the observation group was significantly less than that in the control group (P < 0.05). The BIS values in the observation group were significantly higher than those in the control group during T2 and T3. Conclusion: In oral outpatient surgery, the combination of propofol and esketamine-induced mild sedation can stabilize the hemodynamic indices of patients during surgery, reduce the incidence of complications, and improve patient satisfaction. Abbreviations: BIS- Bispectral Index; HR- Heart Rate; RASS- Richmond Agitation-Sedation Scale; SBP- Systolic Blood Pressure; VAS- Visual Analogue Scale Key words: Mild Sedation; Esketamine; Propofol; Remifentanil; Oral Surgery Citation: Xin Z, Yu T, Wang LL, Qu W, Wang N, Yao M. Clinical application of esketamine-induced mild sedation technique in outpatient oral surgery. Anaesth. pain intensive care 2022;27(6):715−720; DOI: 10.35975/apic.v27i6.2234 Received: May 28, 2023; Revised: October 24, 2023; Accepted: November 08, 2023
- Research Article
2
- 10.4097/kjae.2002.42.2.161
- Jan 1, 2002
- Korean Journal of Anesthesiology
Background: Lidocaine's sedative effect has not been known well. The purpose of this study was to evaluate its sedative and cardiovascular effects during induction of anesthesia. Methods: Twenty patients were randomly allocated to group I or II, with or without lidocaine 1.5 mg/kg intravenously (IV) before induction, respectively. The BIS, blood pressure and heart rate were measured at before and 2 minutes after lidocaine IV injection, prcintubation, and 1, 2, 3 and 5 minutes after tracheal intubation. The enflurane concentrations were continuously maintained at 2 volume%. Results: The BIS of group I was more decreased at 1 and 2 minutes after intubation than those of group II. The systolic blood pressures of group I were less increased at 1 and 2 minutes after intubation than those of group II. The diastolic blood pressures and heart rates of group I were not different from those of group II at each stage of the procedure. Conclusions: Lidocaine reduced BIS and blunted the intubation-induced systolic hypertensive response. In addition it is thought that it has a sedative effect and is effective to maintain cardiovascular stability after tracheal intubation.
- Research Article
4
- 10.1155/2015/282149
- Jan 1, 2015
- Gastroenterology Research and Practice
Background/Aims. This study aimed to establish optimal propofol anesthesia for therapeutic endoscopy, which has not been established. Methodology. We retrospectively investigated data on 89 patients who underwent upper-GI endoscopic submucosal dissection or endoscopic mucosal resection under anesthesia with propofol. Examined doses of propofol were changed according to efficacy and/or adverse events and classified into 5 periods. A bispectral index (BIS) monitor was used at Period 5 to decrease the incidence of adverse events caused by oversedation. The initial dose of propofol was administered after bolus injection of pethidine hydrochloride (0.5 mg/kg), and 1.0 mL of propofol was added every minute until the patients fell asleep. Continuous and bolus infusion were performed to maintain sedation. When the patient moved or an adverse event occurred, the maintenance dose examined was increased or decreased by 5 mL/h regardless of body weight. Results. Dose combinations (introduction : maintenance) and patient numbers for each period were as follows: Period 1 (n = 27), 0.5 mg/kg : 5 mg/kg/h; Period 2 (n = 11), 0.33 mg/kg : 3.3 mg/kg/h; Period 3 (n = 7), 0.5 mg/kg : 3.3 mg/kg/h; Period 4 (n = 14), 0.5 mg/kg : 2.5 mg/kg/h; Period 5 (n = 30), 0.5 mg/kg : 2.5 mg/kg/h, using BIS monitor. During Period 5, an adverse event occurred in 10.0% of patients, which was lower than that for Periods 1–4. Conclusions. Period 5 propofol anesthesia with BIS protocol could be safe and useful for therapeutic endoscopy under deep sedation with spontaneous respiration.
- Research Article
3
- 10.1186/s12912-024-02645-x
- Jan 13, 2025
- BMC nursing
Patients hospitalized outside of monitored environments may experience sudden clinical worsening requiring transfer to the Intensive Care Unit. Early detection based on the clinical nurse's identification of the risk of clinical deterioration represents an opportunity to prevent serious adverse events. Nurse worry is defined as the use of clinical reasoning combined with intuition that precedes the patient's clinical deterioration. The objective of this study was to evaluate nurse worry as a trigger for rapid response team activation in patients hospitalized in non-critical units and its association with the need in ICU admission. This retrospective cohort study utilized data retrieved from an anonymized institutional database used to monitor the actions of the rapid response team. Data collected from January 2021 to December 2022 were analyzed, encompassing patients over 18 years old admitted to non-critical units and evaluated by the rapid response team. Analyzed variables included demographic characteristics, MEWS score, and causes for activating the rapid response team, such as changes in vital signs and nurse worry. Main outcomes assessed were transfer to the ICU, medical procedures, and drug administration. Patients were divided into three groups for analysis: those triggered for RRT assessment exclusively by changes in vital signs, those triggered exclusively by nurse worry and those triggered by the nurse worry combined with changes in vital signs. A total of 4634 rapid response team consultations were included, with 1574 triggered by changes in vital signs, 1263 triggered by nurse worry and 1797 triggered by the nurse worry associated with changes in vital signs. The group with nurse concern showed a lower need for transfers to the ICU (40%) compared to the group with changes in vital signs (50%) p < 0.001 although there was no difference in relation to the need for medical procedures,17% in both groups. The NW emerges as a relevant factor in triggering RRT and may be associated with improved outcomes, such as reduced need for ICU transfers. However, the observational design of the study does not allow for establishing causal relationships.
- Front Matter
13
- 10.1093/bja/aex132
- Jul 1, 2017
- British Journal of Anaesthesia
Triple low, double low: it’s time to deal Achilles heel a single deadly blow
- Research Article
14
- 10.1111/jcpt.13085
- Dec 5, 2019
- Journal of Clinical Pharmacy and Therapeutics
Dexmedetomidine has been a preferred sedative for patients undergoing regional anaesthesia and is mostly administered via conventional zero-order infusion. Recently, a pharmacokinetic-pharmacodynamic (PKPD) model of dexmedetomidine has been published, but no external validation has been reported in clinical trials. We aimed to administer target-controlled infusion (TCI) of dexmedetomidine at the effect-site concentration (Ce) to patients undergoing spinal anaesthesia and investigate the relationship between dexmedetomidine Ce and the sedative effects. Forty-five patients scheduled for orthopaedic surgery received spinal anaesthesia with 0.5% bupivacaine. After confirmation of sensory block level, we initiated effect-site TCI of dexmedetomidine using Colin's model and assessed sedation levels using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale and bispectral index (BIS) with each stepwise increase in the dexmedetomidine Ce. We used a non-linear mixed-effects model to determine the PD relationships between the dexmedetomidine Ce and sedation level. The dexmedetomidine Ce associated with 50% probability (Ce50 ) of the MOAA/S scale ≤4, 3 and 2 was 0.57, 0.89 and 1.19ng/mL, respectively. Mean dexmedetomidine Ce when BIS decreased ≤70 was 0.99±0.15ng/mL. As dexmedetomidine Ce increased, the MOAA/S scale decreased significantly (correlation coefficient [r]=-.832, P<.0001). BIS decreased significantly with increasing dexmedetomidine Ce (r=-.811, P<.0001) and decreasing MOAA/S scale (r=.838, P<.0001). The most common side effects were hypertension (26.67%) and bradycardia (20%). We applied effect-site TCI of dexmedetomidine in patients undergoing spinal anaesthesia for the first time. Dexmedetomidine Ce correlated significantly with MOAA/S scale and BIS, and was 0.89 and 1.19ng/mL for moderate and deep sedation, respectively.
- Discussion
14
- 10.1002/ajmg.a.61105
- Mar 28, 2019
- American Journal of Medical Genetics. Part a
Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the GLA gene that result in functional deficiency of alpha-galactosidase A (α-Gal A); the accumulation of lysosomal α-Gal A substrates can lead to multisystem disease and early death (Germain, 2010; Mehta et al., 2010; Waldek, Patel, Banikazemi, Lemay, & Lee, 2009). Until recently, treatment options were limited to enzyme replacement therapy (ERT) with agalsidase alfa or agalsidase beta administered via infusion every 2 weeks (Gaggl & Sunder-Plassmann, 2016). Migalastat is a first-in-class, small-molecule pharmacological chaperone that binds to and stabilizes amenable mutant forms of α-Gal A in the endoplasmic reticulum, facilitating proper trafficking to lysosomes, where dissociation of migalastat allows α-galactosidase to catabolize accumulated substrates (Benjamin et al., 2009; Germain et al., 2016; Germain & Fan, 2009; Ishii et al., 2007; Khanna et al., 2010; Yam, Zuber, & Roth, 2005). It is estimated that 35–50% of patients with Fabry disease have migalastat-amenable mutations (Hughes et al., 2017). As of July 23, 2018, the total exposure to migalastat in the Phase 2 and 3 clinical programs was 660 patient-years, with 128 patients exposed ≥1 year (Data on file. Amicus Therapeutics Inc., 2018). The efficacy and safety of migalastat in patients with Fabry disease who have amenable GLA mutations have been established in both placebo and active-controlled clinical trials and long-term open-label extension studies (Germain et al., 2016; Germain et al., 2018; Hughes et al., 2017; Nicholls et al., 2018). Oral migalastat has been approved in the European Union, Switzerland, Australia, Israel, Republic of Korea, and Japan for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (α-Gal A deficiency) who have a migalastat-amenable GLA mutation (Amicus Therapeutics Inc., 2018). Migalastat is also approved in the United States and Canada for adults (aged 18 years and older; Amicus Therapeutics U.S., Inc., 2018; Amicus Therapeutics UK Ltd., 2017). We previously reported on Part 1 of the Phase 3 ATTRACT study (AT1001-012; NCT01218659), an 18-month randomized treatment comparison that demonstrated comparable efficacy of migalastat (Cohort 1) and ERT (Cohort 2) in male and female patients with Fabry disease previously treated with ERT for >12 months (Hughes et al., 2017). During Part 2 of the ATTRACT study, patients in both cohorts could receive migalastat for an additional 12 months during the optional open-label extension (OLE). Therefore, both cohorts switched from ERT to migalastat (at baseline for patients randomized at study entry to migalastat [Cohort 1] or month 18 for those randomized to ERT [Cohort 2]). In this article, we assess the safety of switching from ERT to migalastat by evaluating the incidence of adverse events, laboratory assessments, and concomitant medications following switching in both cohorts within the safety population. At study entry, patients ranged in age from 18 to 72 years with a mean age of 49 years; 56% were female (Hughes et al., 2017). Demographics were balanced between cohorts. Mean time since Fabry diagnosis was 11.4 years, and most patients (88%) had multi-organ disease (including nervous system [81%], cardiac [71%], gastrointestinal [61%], and renal/urinary [75%] involvement (Hughes et al., 2017); renal/urinary involvement was defined as having any of the following: a medical history of renal or urinary disorders, decreased estimated glomerular filtration rate (eGFR <90 mL/min/1.73 m2; ~44% of adults aged 40 to 59 have an eGFR below this cutoff [National Kidney Foundation, 2002]), or 24-hr urine protein ≥150 mg). Eight patients had a history of premedication for ERT infusion-associated reactions (IARs; n = 5 in Cohort 1; n = 3 in Cohort 2); 2 patients in Cohort 2 continued IAR prophylaxis during on-study ERT. Fifty-one patients switched from ERT to migalastat: 36 patients in Cohort 1 (Part 1) and 15 patients in Cohort 2 (Part 2/OLE). Most patients continued migalastat treatment until Month 30 (30/36 in Cohort 1 and 12/15 in Cohort 2). Cohort 1 patients switched to migalastat treatment at baseline, by which time most patients had received >2 years of ERT (mean, 3.5 years; Table 1). Prior ERT characteristics were similar between male and female patients. In patients for whom the data were available, migalastat was started 4 to 19 days after their last ERT infusion. The most common treatment-emergent adverse events (AEs) in Cohort 1 (occurring in ≥20% of patients) during the first 18 months were nasopharyngitis (33%) and headache (25%; Table 2), and during the full 30 months were nasopharyngitis (42%), headache (36%), and influenza (27%; Table 2). AEs were generally mild or moderate; no patient discontinued due to an AE. There were no clinically meaningful changes in mean values from baseline for hematology, serum chemistry, urinalysis analysis, and vital signs (Supporting Information Table S1). Thirty-four (94%) Cohort 1 patients started a new medication during months 0–30. The most common new concomitant mediations were amoxicillin (22%), ibuprofen (19%), paracetamol (19%), amoxicillin with clavulanic acid (11%), and temazepam (11%). Only two (6%) patients started a new angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, or renin inhibitor. Overall, based on a review of AEs, laboratory measures, and concomitant medications in Cohort 1, migalastat was well tolerated after patients switched from ERT. Cohort 2 patients switched treatment at Month 18, after most patients completed >3 years of ERT (mean, 5.2 years; Table 1). Nasopharyngitis (33%), headache (24%), and cough (24%) were the most common AEs during the 18-month ERT treatment period in Part 1 (Table 3). In patients for whom the data were available, migalastat was started 2 to 14 days after their last ERT infusion. The most common AEs during 12 months of migalastat treatment in Part 2 were nasopharyngitis (33%), diarrhea (27%), vomiting (27%), influenza (20%), and headache (20%; Table 3). Although the percentages of patients experiencing diarrhea or vomiting increased after the switch to migalastat, these reflect changes in only 1–2 patients and the small patient numbers limit interpretation. There were no clinically meaningful changes in mean values from hematology, serum chemistry, urinalysis analysis, and vital signs following the switch from ERT to migalastat (Supporting Information Table S2). Twelve (80%) Cohort 2 patients started a new medication during months 18–30. The most common new concomitant medications were general anesthetics (13%), clindamycin (13%), ibuprofen (13%), naproxen (13%), and paracetamol (13%). Only 1 (7%) patient started a new angiotensin-converting enzyme inhibitor, angiotensin II receptor blocker, or renin inhibitor. Review of AEs, laboratory measures, and concomitant medications in Cohort 2 did not identify notable safety concerns after switching to migalastat. These data demonstrated a favorable safety profile after patients directly switched to migalastat 150 mg QOD 2 to 19 days following their last ERT infusion. Migalastat was generally well tolerated, and no patients discontinued treatment due to AEs. Reason for discontinuing ERT during 0–18 months was withdrawal by participant (n = 3); reasons for discontinuing migalastat during 0–30 months were withdrawal by participant (n = 4), pregnancy (n = 1), lack of efficacy (n = 1), physician decision unrelated to migalastat (n = 1), and lost to follow-up (n = 1). Limitations of the analysis include the relatively small number of patients who switched from agalsidase beta to migalastat, as most (67%) patients switched from agalsidase alfa because enrollment for ATTRACT coincided with the worldwide shortage of agalsidase beta. Migalastat is the only oral treatment for Fabry disease, which provides a suitable alternative to once-every-2-weeks intravenous ERT in patients with amenable mutations who are ERT-experienced and can also be utilized as a first-line therapy in ERT-naive patients. Although there has not yet been a consensus among physicians who treat patients with Fabry disease on when to choose migalastat over ERT, we have developed some criteria in our clinical practices, which include: age 16 years and older (18 years and older in the United States and Canada), a confirmed amenable mutation, an eGFR > 30 mL/min/1.73 m2, compliance with every-other-day oral administration, and no intention by female patients to become pregnant. Patients' preference and hypersensitivity to ERT are also factors in considering the best treatment option for patients. We suggest having a comprehensive counseling session with the patient to discuss the mechanism of action, clinical data, and approved indication for migalastat, as well as schedule of administration. For patients switching from ERT, migalastat is commonly initiated ~2 weeks after the last dose of ERT based on the infusion interval; however, other practical considerations may influence the exact duration between the last ERT infusion and first dose of migalastat. Migalastat may be safely initiated within days of the last ERT infusion. In conclusion, patients with amenable mutations who have been receiving ERT infusions can be safely switched to migalastat 150 mg QOD, and no special procedure is needed for the switch. The authors would like to thank the patients and clinical investigators who participated in the AT1001-012 study and its open-label extension. Funding for the study was provided by Amicus Therapeutics, Inc. The authors acknowledge the scientific writing services of Brian Zeiler and Hadis Williams. Additional editorial assistance was provided by Lei Bai, PhD, and Cindy Gobbel, PhD, (ApotheCom, Yardley, PA), and was funded by Amicus Therapeutics. The study was designed by the sponsor (Amicus) and a core group of investigators. Data collection and analyses were undertaken by the sponsor (Amicus) in collaboration with investigators. The first draft of the manuscript was written by the first author with medical writing assistance provided by Brian Zeiler. All authors critically reviewed drafts of the manuscript. All authors vouch for the completeness and accuracy of the data and analyses and for the fidelity of the study to the protocol. All authors made the decision to submit the manuscript for publication. DAH has served as a consultant for and received research funding and honoraria from Amicus, Shire, Sanofi Genzyme, Protalix, and Actelion. KN has served as an advisor for Amicus, Shire, and Sanofi Genzyme, has received research support from Amicus and Shire, and has received travel support from Sanofi Genzyme. GS-P has received personal fees and non-financial support from Amicus and grant funding, personal fees, and non-financial support from Shire and Sanofi Genzyme. AJ has received advisory honoraria and speaker's fees from Amicus, Shire, Biomarin and Sanofi Genzyme. UFR reports other support from Amicus during the conduct of the study, grant support and speaker's honoraria from Amicus, Sanofi Genzyme, and Shire outside the submitted work, and research funding from Novo Nordisk Research Foundation. RS has served as a consultant for and received research funding from Amicus and Protalix Biotherapeutics. RG has received honoraria from Amicus, Biomarin, Sanofi Genzyme, and Shire. CV, JPC, NS, and JAB are employees of and hold stock in Amicus. DGB has received research funding, serves as a consultant, and is on the speaker's bureau for Amicus and Sanofi Genzyme, and has received research funding from Shire. Table S1 Change in Laboratory Measurements and Vital Signs After Switch From ERT to Migalastat in Cohort 1 Table S2. Change in Laboratory Measurements and Vital Signs After Switch From ERT to Migalastat in Cohort 2 Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
- Research Article
- 10.3877/cma.j.issn.1673-5250.2009.04.114
- Aug 1, 2009
- Chung-Hua Fu Ch'an K'o Tsa Chih
Objective To evaluate the process and significance of bispectral index(BIS) monitoring in out-patients who underwent artificial abortion under propofol-sufentanil anesthesia. Methods From June to October 2008, 180 patients who were underwent selective artificial abortion under propofol-sufentanil anesthesia were randomly divided into regular monitoring+ BIS monitoring group (group Ⅰ, n=90) and regular clinical monitoring group (group Ⅱ, n=90). Informed consent was obtained from all participates. In group Ⅰ, the maintenance dose of propofol infusion were adjusted to achieve a target bispectral index of 40~55. In group Ⅱ, propofol dose adjustments were made based only on standard clinical signs. The mean airway pressure (MAP), heart rate (HR), pulse oxygen saturation (SpO2) and bispectral index were detected at T0 (at giving drug), T1(loss of eyelash reflex), T2(cervical dilatation), T3(dilatation and curettage), T4(withdrawl vaginal speculum), T5(at analepsia) of two groups. The dosage of propofol, intraoperative response, duration of operation and recovery parameters were recorded. Results There were no significant differences between two groups of general clinical information, mean airway pressure before anaesthesia, heart rate, pulse oxygen saturation, and bispectral index monitoring (P>0.05). The dosage of propofol and duration of postoperative stay in hospital were significantly less and shorter in group Ⅰ than those of group Ⅱ(P<0.01), so did the decrease of mean airway pressure at T1 and T2 (P<0.01). And there also had significant difference of incidence of adverse reactions between two groups(P<0.01). Conclusion Titrating propofol with bispectral index monitoring during intravenous anesthesia for artifical abortion in chinic could prevent propofol under or over dose, decrease the change of haemodynamics, avoid limb movement, keep hemodynamics stable and make recovery quicker. Key words: bispectral index(BIS); feedback; anaesthesia; artificial abortion
- Research Article
- 10.35975/apic.v25i6.1689
- Dec 1, 2021
- Anaesthesia, Pain & Intensive Care
Background: Rapid recovery after anesthesia is critical and is associated with the anesthetic agents used. The bispectral index (BIS) monitoring to guide anesthetic agents' doses may play a significant role in the recovery time. This study compared recovery time after Target Controlled Infusion (TCI) of propofol with sevoflurane anesthesia by using BIS monitoring during vitrectomy surgery. 
 Methodology: This was a prospective observational, randomized study on 40 patients aged 18–65 y, physical status ASA I–II, body mass index (BMI) 18–30 kg/m2, who underwent vitrectomy surgery. Subjects were randomly assigned into two groups, Group P – the TCI propofol group, and Group S – the sevoflurane group. Subjects in the Group P received TCI propofol (Schnider), and subjects in the Group S received sevoflurane for anesthesia maintenance, with a targeted BIS score of 40–60. Inj. fentanyl 1 µg/kg was administered if there was an increase in blood pressure, heart rate and/or BIS that could not be overcome by increasing the dose of TCI propofol or sevoflurane. Recovery time was calculated from when the maintenance regimen was stopped until the patient was able to obey simple commands. Recovery time, fentanyl consumption, postoperative agitation, nausea and vomiting incidence were noted and analyzed with SPSS v21.0 for Windows. T–Test or Mann–Whitney U test was performed to analyze the data. 
 Result: Recovery time in the Group P [11.5 (5–25) min)] was not significantly different from the Group S [9 (4–18) min, p = 0.139]. Total fentanyl consumption was higher in the Group P than in the Group S (1.765 vs. 1.428 µg/kg). The frequency of agitation during recovery was higher in the Group S than in the Group P (30% vs. 20%)
 Conclusion: There was no significant difference in recovery time between target controlled infusion of propofol and BIS controlled sevoflurane anesthesia in vitrectomy. Total fentanyl consumption was higher in the Group P than in the sevoflurane group. The impact of these anesthetic regimens on postoperative agitation needs further investigation.
 Key words: Intravenous anesthesia; Bispectral index monitoring; BIS; Propofol; Sevoflurane; Target Controlled Infusion; TCI; Vitrectomy
 Citation: Tantri AR, Sukmono RB, Atmadja LS. Comparison of recovery time with target controlled infusion of propofol with sevoflurane anesthesia using bispectral index monitoring in vitrectomy surgery. Anaesth. pain intensive care 2021;25(6):707–712:
 DOI: 10.35975/apic.v25i6.1689