Trial Outcomes & Findings for Impact of Anesthetic Choice (Sevoflurane Versus Desflurane) on Airway Reflex Recovery in the Context of Antagonized Neuromuscular Block (NCT NCT01199237)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

107 participants

Primary outcome timeframe

At 2 minutes after response to command (T1).

Results posted on

2014-05-16

Participant Flow

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

Participation of the first 26 enrollees was considered a pilot to determine the feasibility of measuring the primary outcome at T1+5 minutes. The majority of participants were alert, and no meaningful analyses could be made. The study was modified to assess the primary outcome at T1 + 2 minutes, and 81 additional participants were recruited.

Participant milestones

Participant milestones
Measure	Sevoflurane Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)	Desflurane Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
Overall Study STARTED	41	40
Overall Study COMPLETED	41	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sevoflurane n=41 Participants Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)	Desflurane n=40 Participants Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)	Total n=81 Participants Total of all reporting groups
Age, Continuous	45.3 years n=5 Participants	43.3 years n=7 Participants	44.3 years n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	36 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants	40 participants n=7 Participants	81 participants n=5 Participants

PRIMARY outcome

Timeframe: At 2 minutes after response to command (T1).

Population: Only participants judged by the clinician as able to take the test (n=57)

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.

Outcome measures

Outcome measures
Measure	Sevoflurane n=26 Participants Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg) Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water	Desflurane n=31 Participants Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg) Desflurane: 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. able to swallow at T1+2 minutes	16 participants	25 participants
Recovery of Ability to Swallow After Neostigmine/Glycopyrrolate Antagonism of Rocuronium Paralysis. unable to swallow at T1+2 minutes	10 participants	6 participants

SECONDARY outcome

Timeframe: Up to 1 hour post-operative

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.

Outcome measures

Outcome measures
Measure	Sevoflurane n=41 Participants Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg) Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water	Desflurane n=40 Participants Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg) Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water
Time From Potent Inhaled Anesthetic Discontinuation to First Response to Command (T1)	623 seconds Interval 509.0 to 736.0	343 seconds Interval 271.0 to 415.0

SECONDARY outcome

Timeframe: 30 minutes after T1

Population: Only participants able to respond at time of assessment

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

Outcome measures

Outcome measures
Measure	Sevoflurane n=39 Participants Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg) Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water	Desflurane n=39 Participants Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg) Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water
Nausea and Vomiting Nausea	0.385 units on a scale Interval 0.0 to 8.0	1.359 units on a scale Interval 0.0 to 8.0
Nausea and Vomiting Vomiting	0 units on a scale Interval 0.0 to 0.0	0 units on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 60 minutes after T1

Population: Only patients able to respond at time of assessment

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

Outcome measures

Outcome measures
Measure	Sevoflurane n=38 Participants Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg) Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water	Desflurane n=39 Participants Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg) Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water
Nausea and Vomiting Nausea	0.263 units on a scale Interval 0.0 to 4.0	1.333 units on a scale Interval 0.0 to 10.0
Nausea and Vomiting Vomiting	0 units on a scale Interval 0.0 to 0.0	0.026 units on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: up to 60 minutes after T1

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.

Outcome measures

Outcome measures
Measure	Sevoflurane n=41 Participants Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg) Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water	Desflurane n=40 Participants Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg) Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water
Time From Anesthetic Discontinuation to First Ability to Swallow	1275 Seconds Interval 947.0 to 1603.0	718 Seconds Interval 513.0 to 922.0

Adverse Events

Sevoflurane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Desflurane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachel Eshima McKay

University of California, San Francisco

Phone: 415-502-1715

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place