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Trial record 1 of 1 for:    NCT02331108
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A Comparison of Inhalation vs. Intravenous Induction (INHvsIV)

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ClinicalTrials.gov Identifier: NCT02331108
Recruitment Status : Completed
First Posted : January 6, 2015
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Jonathan Roth, Albert Einstein Healthcare Network

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Hypothermia
Intervention Drug: Selection of anesthetic induction technique
Enrollment 331
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sevoflurane in 100% Oxygen, Age <56 Sevoflurane in 50% Nitrous, Age <56 Propofol, Age <56 Propofol With Phenylephrine, Age <56 Sevoflurane in 100% Oxygen, Age >55 Sevoflurane in 50% Nitrous, Age >55
Hide Arm/Group Description

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

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

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

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

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

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

Period Title: Overall Study
Started 51 52 51 51 52 52
Completed 50 50 50 50 50 50
Not Completed 1 2 1 1 2 2
Arm/Group Title Sevoflurane in 100% Oxygen, Age <56 Sevoflurane in 50% Nitrous, Age <56 Propofol, Age <56 Propofol With Phenylephrine, Age <56 Sevoflurane in 100% Oxygen, Age >55 Sevoflurane in 50% Nitrous, Age >55 Total
Hide Arm/Group Description

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

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

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 51 52 51 51 52 52 309
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 51 participants 51 participants 52 participants 52 participants 309 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
 100.0%
52
 100.0%
51
 100.0%
51
 100.0%
21
  40.4%
25
  48.1%
251
  81.2%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
31
  59.6%
27
  51.9%
58
  18.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 52 participants 51 participants 51 participants 52 participants 52 participants 309 participants
42.8  (10.1) 43.0  (8.8) 39.0  (11.2) 40.6  (9.1) 68.2  (8.4) 66.2  (7.4) 50.0  (15.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 51 participants 51 participants 52 participants 52 participants 309 participants
Female
30
  58.8%
20
  38.5%
30
  58.8%
29
  56.9%
19
  36.5%
25
  48.1%
153
  49.5%
Male
21
  41.2%
32
  61.5%
21
  41.2%
22
  43.1%
33
  63.5%
27
  51.9%
156
  50.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants 52 participants 51 participants 51 participants 52 participants 52 participants 309 participants
51 52 51 51 52 52 309
1.Primary Outcome
Title Measurement of Core Temperature
Hide Description Core temperature at 15 minute intervals
Time Frame intraoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sevoflurane in 100% Oxygen, Age <56 Sevoflurane in 50% Nitrous, Age <56 Propofol, Age <56 Propofol With Phenylephrine, Age <56 Sevoflurane in 100% Oxygen, Age >55 Sevoflurane in 50% Nitrous, Age >55
Hide Arm/Group Description:

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

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

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

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

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

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 Number of Participants Analyzed 50 50 50 50 50 50
Mean (Standard Deviation)
Unit of Measure: degree C
15 minute temperature 36.42  (.49) 36.44  (.44) 35.96  (.40) 36.35  (.38) 36.34  (.46) 36.41  (.52)
30 minute temperature 36.41  (.49) 36.48  (.44) 35.95  (.41) 36.36  (.40) 36.31  (.48) 36.38  (.53)
45 minute temperature 36.47  (.53) 36.50  (.43) 36.00  (.45) 36.45  (.40) 36.29  (.50) 36.41  (.57)
60 minute temperature 36.52  (.56) 36.57  (.42) 36.03  (.53) 36.51  (.43) 36.34  (.51) 36.44  (.55)
2.Primary Outcome
Title Temperature Below 36.0 Degrees C
Hide Description Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia
Time Frame Intraoperative
Hide Outcome Measure Data
Hide Analysis Population Description
Percentage of patients who had one core temperature reading below 36.0 degree C in the first hour of anesthesia
Arm/Group Title Sevoflurane in 100% Oxygen, Age <56 Sevoflurane in 50% Nitrous, Age <56 Propofol, Age <56 Propofol With Phenylephrine, Age <56 Sevoflurane in 100% Oxygen, Age >55 Sevoflurane in 50% Nitrous, Age >55
Hide Arm/Group Description:

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

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

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

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

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

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 Number of Participants Analyzed 50 50 50 50 50 50
Measure Type: Number
Unit of Measure: Percentage
8 8 30 8 14 14
3.Secondary Outcome
Title Measurement of Blood Pressure
Hide Description Blood pressure decrease after intravenous anesthetic induction
Time Frame intraoperative
Hide Outcome Measure Data
Hide Analysis Population Description
Percentage of patients whose blood pressure decreased after propofol administration
Arm/Group Title Propofol, Age <56 Propofol With Phenylephrine, Age <56
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: percentage of patients
49 29
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sevoflurane in 100% Oxygen, Age <56 Sevoflurane in 50% Nitrous, Age <56 Propofol, Age <56 Propofol With Phenylephrine, Age <56 Sevoflurane in 100% Oxygen, Age >55 Sevoflurane in 50% Nitrous, Age >55
Hide Arm/Group Description

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

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

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

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

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

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

All-Cause Mortality
Sevoflurane in 100% Oxygen, Age <56 Sevoflurane in 50% Nitrous, Age <56 Propofol, Age <56 Propofol With Phenylephrine, Age <56 Sevoflurane in 100% Oxygen, Age >55 Sevoflurane in 50% Nitrous, Age >55
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Sevoflurane in 100% Oxygen, Age <56 Sevoflurane in 50% Nitrous, Age <56 Propofol, Age <56 Propofol With Phenylephrine, Age <56 Sevoflurane in 100% Oxygen, Age >55 Sevoflurane in 50% Nitrous, Age >55
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/52 (0.00%)   0/51 (0.00%)   0/51 (0.00%)   0/52 (0.00%)   0/52 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sevoflurane in 100% Oxygen, Age <56 Sevoflurane in 50% Nitrous, Age <56 Propofol, Age <56 Propofol With Phenylephrine, Age <56 Sevoflurane in 100% Oxygen, Age >55 Sevoflurane in 50% Nitrous, Age >55
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/52 (0.00%)   0/51 (0.00%)   0/51 (0.00%)   0/52 (0.00%)   0/52 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jonathan Roth, M.D.
Organization: Albert Einstein Healthcare Network
Phone: 2154567979
EMail: rothj@einstein.edu
Layout table for additonal information
Responsible Party: Jonathan Roth, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT02331108    
Other Study ID Numbers: HN4613
First Submitted: November 20, 2014
First Posted: January 6, 2015
Results First Submitted: February 6, 2017
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017