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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01199237
First received: August 23, 2010
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Airway Reflexes, Protective
Recovery After Neuromuscular Block
Anesthetic Recovery
Drug: Sevoflurane
Drug: Desflurane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Anesthetic Choice (Sevoflurane Versus Desflurane) on Speed and Sustained Nature of Airway Reflex Recovery in the Context of Antagonized Neuromuscular Block

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Recovery of ability to swallow after neostigmine/glycopyrrolate antagonism of rocuronium paralysis. [ Time Frame: At 2 minutes after response to command (T1). ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 107
Study Start Date: August 2010
Study Completion Date: August 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sevoflurane
Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Drug: Sevoflurane
Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water
Active Comparator: Desflurane
Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Drug: Desflurane
Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA 1-2 patients
  • Age 18-65 years
  • body mass index (BMI) ≤ 35kg/m2
  • Planned surgery requiring general anesthesia lasting approximately 1.5-3.0 hours
  • Surgery requires or benefits from skeletal muscle relaxation
  • All must pass the baseline 20 mL water swallowing test as previously described.

Exclusion Criteria:

  • Pre-existing neuromuscular or central nervous system disorder
  • Known condition interfering with gastric emptying
  • Planned surgical procedure on the head or neck
  • Known liver disease
  • Serum creatinine > 1.5 mg/dL
  • Concurrent use of neuroleptic medications
  • Contraindication or previous adverse response to any of the study drugs
  • Active asthma or reactive airways disease
  • Surgery where upright position or brief cough would be contraindicated
  • Inability to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199237

Locations
United States, California
UCSF Moffitt-Long Hospital
San Francisco, California, United States, 94143
UCSF Helen Diller Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Baxter Healthcare Corporation
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01199237     History of Changes
Other Study ID Numbers: H10722-35629-01
Study First Received: August 23, 2010
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Reflex, Pharyngeal
Anesthetics, Inhalation

Additional relevant MeSH terms:
Anesthetics
Desflurane
Sevoflurane
Anesthetics, Inhalation
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on April 17, 2014