CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 107 enrolled
Drug / intervention
Sevoflurane +4 moredrug
Likely dose
Sevoflurane 20 mLfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01199237
NCT01199237Phase 4Completed

Effect of Anesthetic Choice (Sevoflurane Versus Desflurane) on Speed and Sustained Nature of Airway Reflex Recovery in the Context of Antagonized Neuromuscular Block

University of California, San Francisco·interventional·Posted Sep 10, 2010·Updated May 16, 2014

In Brief

A Phase 4 clinical trial evaluating Sevoflurane, Desflurane, and 3 other interventions for Airway Reflexes, Protective and 2 related conditions. Completed, enrolled 107 participants across 2 sites.

Detailed Summary

Protective airway reflexes may be impaired in the postoperative period, creating the potential for aspiration of gastric contents, even after a patient exhibits appropriate response to command. Because assessment of airway reflex recovery is not possible in an intubated patient, the clinician must make an empiric decision as to when a patient is safe to extubate, and choose a combination of techniques least likely to result in pharyngeal impairment. Adequacy of reversal of neuromuscular block by cholinesterase inhibitors (e.g., neostigmine) is unpredictable, especially in the presence of profound paralysis, and tactile assessment of train-of four and sustained tetanus has shown poor correlation with objective assessments. Protective airway reflexes may also be impaired during early recovery by the anesthetics themselves, even when muscle relaxant has been avoided. In the absence of muscle relaxant the investigators previously demonstrated that patients receiving an anesthetic with higher tissue solubility, sevoflurane showed significantly greater impairment of swallowing up to 14 minutes after response to command compared to patients receiving an anesthetic with lower tissue solubility, desflurane. Therefore, we ask whether the combination of the more soluble anesthetic and the presence of neuromuscular block antagonized by neostigmine may create a multiplicative effect that might further prolong pharyngeal recovery. We plan to randomly assign 100 patients scheduled to undergo surgery with general anesthesia to a standardized anesthetic that includes 1) sevoflurane, rocuronium with 70 µg/kg neostigmine + 14 µg/kg glycopyrrolate antagonism (group S); or 2) desflurane, rocuronium with 70 µg/kg neostigmine + 14 µg/kg glycopyrrolate antagonism (group D). Airway reflex recovery will be judged as adequate by the patient's ability to swallow 20 mL of water without coughing or drooling 5, 10, 15, 20, 30 and 60 minutes after response to command. Anesthetic (sevoflurane or desflurane) will be discontinued after administration of reversal agent and recovery to TOF (train-of-four) ratio of 0.7.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2010
Enrollment StartAug 1, 2010
Primary CompletionAug 1, 2012
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.8 years ago

Interventions

Sevofluranedrug

Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water

Desfluranedrug

Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water

Rocuroniumdrug

Neostigminedrug

Glycopyrrolatedrug