Trial Outcomes & Findings for A Comparison of Inhalation vs. Intravenous Induction (NCT NCT02331108)

Results Overview

Core temperature at 15 minute intervals

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

331 participants

Primary outcome timeframe

intraoperative

Results posted on

2017-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	Sevoflurane in 100% Oxygen, Age <56 The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Sevoflurane in 50% Nitrous, Age <56 The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Propofol, Age <56 The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Propofol With Phenylephrine, Age <56 The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Sevoflurane in 100% Oxygen, Age >55 The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age \>55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Sevoflurane in 50% Nitrous, Age >55 The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age \>55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes
Overall Study STARTED	51	52	51	51	52	52
Overall Study COMPLETED	50	50	50	50	50	50
Overall Study NOT COMPLETED	1	2	1	1	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sevoflurane in 100% Oxygen, Age <56 n=51 Participants The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Sevoflurane in 50% Nitrous, Age <56 n=52 Participants The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Propofol, Age <56 n=51 Participants The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Propofol With Phenylephrine, Age <56 n=51 Participants The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Sevoflurane in 100% Oxygen, Age >55 n=52 Participants The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age \>55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Sevoflurane in 50% Nitrous, Age >55 n=52 Participants The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age \>55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Total n=309 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=51 Participants	0 Participants n=52 Participants	0 Participants n=51 Participants	0 Participants n=51 Participants	0 Participants n=52 Participants	0 Participants n=52 Participants	0 Participants n=309 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=51 Participants	52 Participants n=52 Participants	51 Participants n=51 Participants	51 Participants n=51 Participants	21 Participants n=52 Participants	25 Participants n=52 Participants	251 Participants n=309 Participants
Age, Categorical >=65 years	0 Participants n=51 Participants	0 Participants n=52 Participants	0 Participants n=51 Participants	0 Participants n=51 Participants	31 Participants n=52 Participants	27 Participants n=52 Participants	58 Participants n=309 Participants
Age, Continuous	42.8 years STANDARD_DEVIATION 10.1 • n=51 Participants	43.0 years STANDARD_DEVIATION 8.8 • n=52 Participants	39.0 years STANDARD_DEVIATION 11.2 • n=51 Participants	40.6 years STANDARD_DEVIATION 9.1 • n=51 Participants	68.2 years STANDARD_DEVIATION 8.4 • n=52 Participants	66.2 years STANDARD_DEVIATION 7.4 • n=52 Participants	50.0 years STANDARD_DEVIATION 15.3 • n=309 Participants
Sex: Female, Male Female	30 Participants n=51 Participants	20 Participants n=52 Participants	30 Participants n=51 Participants	29 Participants n=51 Participants	19 Participants n=52 Participants	25 Participants n=52 Participants	153 Participants n=309 Participants
Sex: Female, Male Male	21 Participants n=51 Participants	32 Participants n=52 Participants	21 Participants n=51 Participants	22 Participants n=51 Participants	33 Participants n=52 Participants	27 Participants n=52 Participants	156 Participants n=309 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	51 participants n=51 Participants	52 participants n=52 Participants	51 participants n=51 Participants	51 participants n=51 Participants	52 participants n=52 Participants	52 participants n=52 Participants	309 participants n=309 Participants

PRIMARY outcome

Timeframe: intraoperative

Core temperature at 15 minute intervals

Outcome measures

Outcome measures
Measure	Sevoflurane in 100% Oxygen, Age <56 n=50 Participants The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Sevoflurane in 50% Nitrous, Age <56 n=50 Participants The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Propofol, Age <56 n=50 Participants The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Propofol With Phenylephrine, Age <56 n=50 Participants The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Sevoflurane in 100% Oxygen, Age >55 n=50 Participants The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age \>55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Sevoflurane in 50% Nitrous, Age >55 n=50 Participants The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age \>55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes
Measurement of Core Temperature 15 minute temperature	36.42 degree C Standard Deviation .49	36.44 degree C Standard Deviation .44	35.96 degree C Standard Deviation .40	36.35 degree C Standard Deviation .38	36.34 degree C Standard Deviation .46	36.41 degree C Standard Deviation .52
Measurement of Core Temperature 30 minute temperature	36.41 degree C Standard Deviation .49	36.48 degree C Standard Deviation .44	35.95 degree C Standard Deviation .41	36.36 degree C Standard Deviation .40	36.31 degree C Standard Deviation .48	36.38 degree C Standard Deviation .53
Measurement of Core Temperature 45 minute temperature	36.47 degree C Standard Deviation .53	36.50 degree C Standard Deviation .43	36.00 degree C Standard Deviation .45	36.45 degree C Standard Deviation .40	36.29 degree C Standard Deviation .50	36.41 degree C Standard Deviation .57
Measurement of Core Temperature 60 minute temperature	36.52 degree C Standard Deviation .56	36.57 degree C Standard Deviation .42	36.03 degree C Standard Deviation .53	36.51 degree C Standard Deviation .43	36.34 degree C Standard Deviation .51	36.44 degree C Standard Deviation .55

PRIMARY outcome

Timeframe: Intraoperative

Population: Percentage of patients who had one core temperature reading below 36.0 degree C in the first hour of anesthesia

Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia

Outcome measures

Outcome measures
Measure	Sevoflurane in 100% Oxygen, Age <56 n=50 Participants The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Sevoflurane in 50% Nitrous, Age <56 n=50 Participants The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Propofol, Age <56 n=50 Participants The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Propofol With Phenylephrine, Age <56 n=50 Participants The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Sevoflurane in 100% Oxygen, Age >55 n=50 Participants The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age \>55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes	Sevoflurane in 50% Nitrous, Age >55 n=50 Participants The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age \>55. Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes
Temperature Below 36.0 Degrees C	8 Percentage	8 Percentage	30 Percentage	8 Percentage	14 Percentage	14 Percentage

SECONDARY outcome

Timeframe: intraoperative

Population: Percentage of patients whose blood pressure decreased after propofol administration

Blood pressure decrease after intravenous anesthetic induction