A Phase 4 interventional study of Sevoflurane and Desflurane in Airway Reflexes, Protective, Recovery After Neuromuscular Block and Anesthetic Recovery, sponsored by University of California, San Francisco. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-05-16.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
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.
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Exclusion Criteria:
Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Drug: Sevoflurane · Drug: Rocuronium · Drug: Neostigmine · Drug: Glycopyrrolate
Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Drug: Desflurane · Drug: Rocuronium · Drug: Neostigmine · Drug: Glycopyrrolate
Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water
Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water
Recovery of Ability to Swallow After Neostigmine/Glycopyrrolate Antagonism of Rocuronium Paralysis.
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.
Time frame: At 2 minutes after response to command (T1).
Time From Potent Inhaled Anesthetic Discontinuation to First Response to Command (T1)
At the conclusion of surgery, after the patient's potent inhaled anesthetic was discontinued, the commands "open your eyes" and "squeeze my hand" were given at 30-second intervals. The time at which patient first appropriately response to both commands was noted as T1.
Time frame: Up to 1 hour post-operative
Nausea and Vomiting
Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable
Time frame: 30 minutes after T1
Nausea and Vomiting
Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable
Time frame: 60 minutes after T1
Time From Anesthetic Discontinuation to First Ability to Swallow
At 2 minutes after first response to command (T1), the patient was asked to swallow 20 mL of water from a paper cup, and an observer blinded to anesthetic assignment assessed the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag (indicating misdirection of the water bolus into the laryngeal inlet). This test was repeated at 6, 14, 22, 30 and 60 minutes after the time of first response to command.
Time frame: up to 60 minutes after T1
At one U.S. clinical site, patients scheduled to undergo surgery requiring general anesthesia lasting approximately 1.5 - 3.0 hours requiring tracheal intubation and paralysis during surgery were invited to participate
| Milestone | Sevoflurane | Desflurane |
|---|---|---|
| Started | 41 | 40 |
| Completed | 41 | 40 |
| Not completed | 0 | 0 |
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.
| participants | Sevoflurane | Desflurane |
|---|---|---|
| able to swallow at T1+2 minutes | 16 | 25 |
| unable to swallow at T1+2 minutes | 10 | 6 |
At the conclusion of surgery, after the patient's potent inhaled anesthetic was discontinued, the commands "open your eyes" and "squeeze my hand" were given at 30-second intervals. The time at which patient first appropriately response to both commands was noted as T1.
| seconds | Sevoflurane | Desflurane |
|---|---|---|
| Time From Potent Inhaled Anesthetic Discontinuation to First Response to Command (T1) | 623 (509 to 736) | 343 (271 to 415) |
Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable
| units on a scale | Sevoflurane | Desflurane |
|---|---|---|
| Nausea | 0.385 (0 to 8) | 1.359 (0 to 8) |
| Vomiting | 0 (0 to 0) | 0 (0 to 0) |
Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable
| units on a scale | Sevoflurane | Desflurane |
|---|---|---|
| Nausea | 0.263 (0 to 4) | 1.333 (0 to 10) |
| Vomiting | 0 (0 to 0) | 0.026 (0 to 1) |
At 2 minutes after first response to command (T1), the patient was asked to swallow 20 mL of water from a paper cup, and an observer blinded to anesthetic assignment assessed the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag (indicating misdirection of the water bolus into the laryngeal inlet). This test was repeated at 6, 14, 22, 30 and 60 minutes after the time of first response to command.
| Seconds | Sevoflurane | Desflurane |
|---|---|---|
| Time From Anesthetic Discontinuation to First Ability to Swallow | 1275 (947 to 1603) | 718 (513 to 922) |
Collected over 1-2 hours postoperatively. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sevoflurane | — | 0/41 (0%) | 0/41 (0%) |
| Desflurane | — | 0/40 (0%) | 0/40 (0%) |
| Age, Continuous(years) | Sevoflurane | Desflurane | Total |
|---|---|---|---|
| Mean | 45.3 (42.0 to 48.7) | 43.3 (40.2 to 46.5) | 44.3 (40.2 to 48.7) |
| Sex: Female, Male(Participants) | Sevoflurane | Desflurane | Total |
|---|---|---|---|
| Female | 41 | 36 | 77 |
| Male | 0 | 4 | 4 |
| Region of Enrollment(participants) | Sevoflurane | Desflurane | Total |
|---|---|---|---|
| United States | 41 | 40 | 81 |
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