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NCT01199237 · ClinicalTrials.gov registry record · Phase 4

Impact of Anesthetic Choice (Sevoflurane Versus Desflurane) on Airway Reflex Recovery in the Context of Antagonized Neuromuscular Block

A Phase 4 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 4
Development phase
107
Enrollment target

NCT01199237: Completed Phase 4 study, sponsored by University of California, San Francisco.

NCT01199237 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 107 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01199237, a Phase 4 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 4
Development phase
107 participants
Enrollment target

Study 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 de

Primary Outcome

The patient is judged by the primary anesthetist to be awake at time T1. At 2 minutes after T1, the patient was asked to swallow 20mL of water from a paper cup, and a blinded observer judged the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag.

Interventions

  • DRUG Rocuronium
  • DRUG Neostigmine
  • DRUG Sevoflurane
  • DRUG Glycopyrrolate
  • DRUG Desflurane

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2010-08
Est. Completion 2013-08
Phase Phase 4

What the finished NCT01199237 record still lists

NCT01199237 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 5 interventions - of which Rocuronium is the first listed.

NCT01199237 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01199237 about?

NCT01199237 is a clinical study titled "Impact of Anesthetic Choice (Sevoflurane Versus Desflurane) on Airway Reflex Recovery in the Context of Antagonized Neuromuscular Block". 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 m...

What is the current status of trial NCT01199237?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 107 participants. The study started on 2010-08. Estimated completion is 2013-08.

What interventions are being tested in trial NCT01199237?

The interventions under investigation include: Rocuronium (DRUG), Neostigmine (DRUG), Sevoflurane (DRUG), Glycopyrrolate (DRUG), Desflurane (DRUG).

Who is sponsoring clinical trial NCT01199237?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01199237's enrollment target sits among peer trials

107 745th of 2000 higher than 1,254 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01199237, the US trial registry maintained by the National Library of Medicine. NCT01199237 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.