Impact of Anesthetic Choice (Sevoflurane Versus Desflurane) on Airway Reflex Recovery in the Context of Antagonized Neuromuscular Block
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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 |
- Recovery of ability to swallow after neostigmine/glycopyrrolate antagonism of rocuronium paralysis. [ Time Frame: At 5 minutes after response to command. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Sevoflurane
Patients receiving sevoflurane for anesthetic maintenance
|
Drug: Sevoflurane
Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water
|
|
Active Comparator: Desflurane
Patients receiving desflurane for anesthetic maintenance
|
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 |
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| Contact: Rachel Eshima McKay, M.D. | (415) 502-1715 | eshimar@anesthesia.ucsf.edu |
| United States, California | |
| UCSF Moffitt-Long Hospital | Recruiting |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: Rachel Eshima McKay, M.D. | |
| UCSF Helen Diller Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Rachel Eshima McKay, M.D. 415-502-1715 eshimar@anesthesia.ucsf.edu | |
| Principal Investigator: Rachel Eshima McKay, M.D. | |
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: | March 28, 2012 |
| 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 May 16, 2013