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Emergence times and airway reactions in general laryngeal mask airway anesthesia: study protocol for a randomized controlled trial.

ABSTRACT: The use of a laryngeal mask airway (LMA) in appropriate patients supports fast-track anesthesia with a lower incidence of postoperative airway-connected adverse events. Data on the most favorable anesthetic in this context, with the lowest rate of upper airway complications and fast emergence times, are controversial and limited. Desflurane seems to match these criteria best, but large randomized controlled trials (RCTs) with a standardized study protocol are lacking. Therefore, we aim to compare desflurane with other commonly used anesthetics, sevoflurane and propofol, in a sufficiently powered RCT. We hypothesize that desflurane is noninferior regarding the frequency of upper airway events and superior regarding the emergence times to sevoflurane and propofol.A total of 351 patients undergoing surgery with an LMA will be included in this prospective, randomized, double-blind controlled, multicenter clinical trial. The patients will be randomly assigned to the three treatment arms: desflurane (n = 117), sevoflurane (n = 117), and propofol (n = 117). The emergence time (time to state the date of birth) will be the primary endpoint of this study. The secondary endpoints include further emergence times, such as time to open eyes, to remove LMA, to respond to command and to state name. Additionally, we will determine the frequency of cough and laryngospasm, measured intraoperatively and at emergence. We will assess the postoperative recovery on the first postoperative day via the Postoperative Quality Recovery Scale.Despite increasing importance of cost-effective and safe anesthesia application, we lack proof for the most advantageous anesthetic agent, when an LMA is used. There are only a few RCTs comparing desflurane to other commonly used anesthetics (sevoflurane, propofol and isoflurane) in patients with LMA. These RCTs were conducted with small sample sizes, huge interstudy variability, and some also showed strong biases. The present multicenter RCT will provide results from a large sample size with a standardized study protocol and minimized bias, which is feasible in the clinical routine. Furthermore, we will expand our knowledge regarding the most favorable recovery on the first postoperative day, which impacts patients' comfort after surgery.EudraCT Identifier: 2014-003810-96, 5 September 2014 ClinicalTrials.gov: NCT02322502, December 2014.

SUBMITTER: Stevanovic A

PROVIDER: S-EPMC4515321 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Emergence times and airway reactions in general laryngeal mask airway anesthesia: study protocol for a randomized controlled trial.

Stevanovic Ana A Rossaint Rolf R Keszei András P AP Fritz Harald H Fröba Gebhard G Pühringer Friedrich F Coburn Mark M

Trials 20150726

<h4>Background</h4>The use of a laryngeal mask airway (LMA) in appropriate patients supports fast-track anesthesia with a lower incidence of postoperative airway-connected adverse events. Data on the most favorable anesthetic in this context, with the lowest rate of upper airway complications and fast emergence times, are controversial and limited. Desflurane seems to match these criteria best, but large randomized controlled trials (RCTs) with a standardized study protocol are lacking. Therefor ...[more]

PMID: 26210907

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Project description:BackgroundDesflurane's short emergence time supports fast track anaesthesia. Data on the rate of upper airway complications and emergence time when desflurane is used with laryngeal mask airway (LMA) are controversial and limited.ObjectivesTo compare recovery time variables and the rates of upper airway adverse events in patients with an LMA undergoing general surgery with desflurane, sevoflurane, isoflurane or propofol anaesthesia.DesignA systematic review and meta-analysis of randomised controlled trials (RCTs).Data sourcesA systematic search for eligible RCTs in Embase (Elsevier) and in PubMed (National Library of Medicine) databases up to September 2013.Eligibility criteriaRCTs investigating the rates of cough overall, cough at emergence, laryngospasm, time to eye opening, time to removal of the LMA, time to respond to command and time to state date of birth in patients with an LMA, during emergence from desflurane, sevoflurane, isoflurane or propofol anaesthesia.ResultsThirteen RCTs were included and analysed. We found a strong interstudy variability. There was no difference in the rates of upper airway events between desflurane and sevoflurane or between desflurane and a control group consisting of all the other anaesthetics combined. Comparing desflurane (n?=?284) with all other anaesthetic groups (n?=?313), the risk ratio [95% confidence interval (95% CI)] was 1.12 (0.63 to 2.02, P?=?0.70). Cough at emergence was only measured in patients receiving desflurane (n?=?148) and sevoflurane (n?=?146): the risk ratio (95% CI) was 1.49 (0.55 to 4.02, P?=?0.43). Laryngospasm was rare and there was no significant difference in its incidence when desflurane (n?=?262) was compared with all other anaesthetics combined (n?=?289; risk ratio 1.03; 95% CI 0.33 to 3.20, P?=?0.96). The times of all emergence variables were significantly faster in the desflurane group than in all other groups.ConclusionWhen using an LMA, upper airway adverse reactions in association with desflurane anaesthesia were no different from those noted with sevoflurane, isoflurane or propofol anaesthesia. Emergence from general anaesthesia with desflurane is significantly faster than all the other anaesthetics. Due to interstudy variations and the small size of the trials, further large-scale, multicentre studies are required to confirm or refute the results of this meta-analysis.

Project description:BACKGROUND:Avoidance of airway complications and rapid emergence from anaesthesia are indispensable for the use of a laryngeal mask airway (LMA). Evidence from adequately powered randomised studies with a low risk of bias for the optimal anaesthetic in this context is limited. OBJECTIVE:We tested the hypothesis that when using remifentanil-based intra-operative analgesia, desflurane would be the most suitable anaesthetic: with noninferiority in the occurrence of upper airway complications and superiority in emergence times compared with sevoflurane or propofol. DESIGN:A randomised, multicentre, partially double-blinded, three-arm, parallel-group study. SETTING:Two university and two regional German hospitals, from February to October 2015. PATIENTS:A total of 352 patients (age 18 to 75 years, ASA physical status I to III, BMI less than 35?kg?m and fluent in German) were enrolled in this study. All surgery was elective with a duration of 0.5 to 2?h, and general anaesthesia with a LMA was feasible. INTERVENTION:The patients were randomised to receive desflurane, sevoflurane or propofol anaesthesia. MAIN OUTCOME MEASURES:This study was powered for the primary outcome 'time to state date of birth' and the secondary outcome 'intra-operative cough'. Time to emergence from anaesthesia and the incidence of upper airway complications were assessed on the day of surgery. RESULTS:The primary outcome was analysed for 343 patients: desflurane (n=114), sevoflurane (n=111) and propofol (n=118). The desflurane group had the fastest emergence. The mean (± SD) times to state the date of birth following desflurane, sevoflurane and propofol were 8.1?±?3.6, 10.1?±?4.0 and 9.8?±?5.1?min, respectively (P?<?0.01). There was no difference in upper airway complications (cough and laryngospasm) across the groups, but these complications were less frequent than in previous studies. CONCLUSION:When using a remifentanil infusion for intra-operative analgesia in association with a LMA, desflurane was associated with a significantly faster emergence and noninferiority in the incidence of intra-operative cough than either sevoflurane or Propofol. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT02322502; EudraCT identifier: 2014-003810-96.

Project description:BACKGROUND:The obstetric airway is a significant cause of maternal morbidity and mortality. Endotracheal intubation is considered the standard of care but the laryngeal mask airway (LMA) has gained acceptance as a rescue airway and has been incorporated into the obstetric airway management guidelines. In this randomized controlled equivalence trial, we compared the Supreme LMA (SLMA) with endotracheal intubation (ETT) in managing the obstetric airway during cesarean section. METHODS:Parturients who underwent elective cesarean section under general anesthesia were randomized to receive either an SLMA or ETT as their airway device. Our primary outcome was first-attempt insertion success. Successful insertion was defined as adequate bilateral air entry with auscultation and the presence of end-tidal carbon dioxide on the capnogram. The first-attempt insertion success rate was compared using the Chi-Square test. Secondary outcomes included time-to-ventilation, seal pressure, ventilation/hemodynamic parameters, occurrence of clinical aspiration, fetal outcomes, and maternal side effects associated with the airway device. RESULTS:We recruited 920 parturients (460 SLMA, 460 ETT) who underwent elective cesarean section under general anesthesia. Patient characteristics were similar between the groups. First attempt success was similar (Odds Ratio--ORSLMA/ETT: 1.00 (95%CI: 0.25, 4.02), p?=?1.0000). SLMA was associated with reduced time to effective ventilation (Mean Difference--MD -22.96; 95%CI: -?23.71, -?22.21?s) compared to ETT group (p?<? 0.0001). Ventilation parameters, maternal and fetal outcomes were similar between the groups, and there was no aspiration. CONCLUSIONS:SLMA could be an alternative airway management technique for a carefully selected low-risk obstetric population, with similar insertion success rates, reduced time to ventilation and less hemodynamic changes compared with ETT. Our findings are consistent with the airway guidelines in recommending the second-line use of LMA in the management of the obstetric airway. TRIAL REGISTRATION:The study was registered at http://www.clinicaltrials.gov , identifier: NCT01858467 , retrospectively registered. Date of registration: May 21, 2013.

Project description:Background:Several studies have identified side effects of general anesthesia with endotracheal intubation, such as laryngeal pain, dysphonia, and postoperative nausea and vomiting (PONV). The laryngeal mask airway (LMAw) is believed to decrease these side effects. The aim of this trial was to compare postoperative discomfort, emergence delirium, and recovery time of patients who received either an LMAw or nasotracheal intubation (NTI). Patients and methods:A total of 70 children were randomly assigned to the LMAw group (n=35) or the NTI group (n=35). Both groups underwent mask induction with 8% sevoflurane. The NTI group received muscle relaxant, whereas the LMAw group did not. Postoperative laryngeal pain, dental pain, dysphonia, and PONV were assessed immediately and at 1 hour and 6 hours postoperatively. The Wong-Baker Faces Scale was used to evaluate the patients' self-reported pain. In addition, decayed, missing, and filled teeth (dft/DMFT) values, dental procedure type, number of dental procedures, duration of the dental operation, duration of anesthesia, recovery time, emergence delirium, pediatric dentist's access to the mouth, and parents' satisfaction levels were recorded. Data were analyzed using descriptive statistics, chi-square tests, and two-sample t-tests. Results:The incidence of postoperative laryngeal pain was significantly higher in the NTI group immediately (97.2% vs. 8.5%, P=0.00), 1 hour (94.2% vs. 0%, P=0.00), and 6 hours postoperatively (25.7% vs. 0%, P=0.00). There were no statistically significant differences between the two groups in dental pain scores, dft/DMFT values, duration of anesthesia, duration of the dental operation, number of dental procedures, the incidence of PONV, or pediatric dentist's access to the mouth (P>0.05). Emergence delirium and recovery time were significantly higher in the NTI group (P<0.05). Conclusion:The LMAw provided a more comfortable postoperative period than NTI for children who underwent full-mouth dental rehabilitation under general anesthesia.

Project description:BACKGROUND:Obstetric dfficult airway is a leading cause of maternal morbidity and mortality. The laryngeal mask airway (LMA) is often used as a rescue airway device after failed intubation, however, little is known about predictors of difficult LMA insertion, particularly in obstetrics. Since Mallampati scores of III/IV has been associated with difficult tracheal intubation, our present study aims to investigate if Mallampati score (MP) could predict airway outcomes for LMA use in obstetrics. METHODS:This prospective cohort study was performed at a single-center: Quanzhou Women's and Children's Hospital, Fujian Province, China. Five hundred and eighty-four parturients undergoing elective cesarean section under general anesthesia were recruited. The primary outcome was time to effective ventilation, and secondary outcomes included first attempt insertion success, seal pressure, ventilation and hemodynamic parameters, occurrence of clinical aspiration, and maternal and fetal outcomes. RESULTS:The parturients were classified into two groups based on MP of III/IV (High MP: 61) versus I/II (Low MP: 523). BMI was higher in the High MP group than in the Low MP group (mean (SD) 29.3 (7.0) vs 26.8 (3.1), p?<? 0.0001). There was no difference in maternal age, ASA status and gestational age. There was similar time to effective ventilation (mean (SD) High MP: 14.9 (4.5) vs Low MP: 15.7 (4.4) seconds, p?=?0.2172), and first attempt success rate, seal pressure, and peak airway pressure. No clinical aspiration was noted. The incidence of blood on SLMA was higher in the High MP group than in Low MP (4 (6.6%) vs 4 (0.8%), p?=?0.001). There was no difference in sore throat, voice hoarseness, maternal satisfaction and fetal outcomes. CONCLUSION:High MP was not associated with reduced SLMA airway outcomes in cesarean section under general anesthesia, but may increase the risk of blood found on SLMA upon removal. TRIAL REGISTRATION:This study was registered at http://www.clinicaltrials.gov , identifier: NCT02026882 , retrospectively registered. Date of registration: December 31, 2013.

Project description:The Guardian Laryngeal Mask Airway (G-LMA) is a new silicone-based single-use extraglottic device with the drainage port and a cuff pilot valve with pressure indicator. The aim of this study is to compare the clinical performance of this laryngeal mask airway with ProSeal laryngeal mask airway (P-LMA).In this prospective randomized study, we included adult patients with ASA grading I and II scheduled for elective surgery requiring supine position under total intravenous anesthesia. The patients were randomly allocated to two groups, 40 in each. G-LMA and P-LMA were used in groups G and P respectively. The cuff of each device was air inflated to 60 cmH2O. The primary outcome was to compare the airway sealing pressure and the secondary outcome was to compare the efficacy and safety of these two devices with respect to insertion success, insertion time, ease of insertion, volume of air for cuff inflation to 60 cmH2O, intracuff pressure measurement, gastric tube insertion attempt, gastric tube insertion time, Fiberoptic laryngeal view, and postoperative pharyngolaryngeal morbidity.The airway sealing pressure at 60 cmH2O cuff pressure was significantly greater in G-LMA than P-LMA (p?=?0.04).The first successful attempt of both groups were comparable (p?=?1.000). Insertion time was significantly shorter in G-LMA than P-LMA (p?<?0.0001). The first successful attempt for the gastric tube insertion in both groups was comparable (p?=?0.431). Gastric tube insertion time was less in G-LMA than in P-LMA (p?<?0.0001). The volume of air for cuff inflation to 60 cmH2O was more in G-LMA than in P-LMA (<0.0001). The intracuff pressure measurement at 30, 60, 90 and 120 minutes were comparable (p?=?0.823, 0.182, 0.870, 0.658).We did not find differences in ease of insertion (p?=?0.60); Fiber-optic positions of airway devices were comparable (p?=?0.83). In addition, blood staining (p?=?1.00), sore throat and dysphagia at 1, 2 and 24 hour (p?=?1.00) were comparable in both groups.The Guardian laryngeal mask airway was associated with high airway sealing pressure with a quicker insertion of the device as well as gastric tube.Clinical Trial.gov Identifier: NCT02063516. Date: June 2013.

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Emergence times and airway reactions in general laryngeal mask airway anesthesia: study protocol for a randomized controlled trial.

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Emergence times and airway reactions in general laryngeal mask airway anesthesia: study protocol for a randomized controlled trial.

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