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A Comparison of Inhalation vs. Intravenous Induction (INHvsIV)

Primary Purpose

Hypothermia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Selection of anesthetic induction technique
Sponsored by
Albert Einstein Healthcare Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Elective surgery Adult, age >= 18 years old Scheduled for general anesthesia Medically fit and able to safely go any of the four anesthetic inductions in the study

Exclusion Criteria:

Emergency surgery, or any other aspiration risk Minor, age <18 Pregnant Febrile illness Contraindication to nasal instrumentation Allergy to propofol Malignant hyperthermia Requiring Total Invravenous Anesthesia (TIVA) Inability to oxygenate on less than 50% FiO2 Intra-cranial surgery Receiving vasoactive medications Significant valvular heart disease Unstable cardiac disease Surgery requiring prone or lateral positioning Contraindication to nitrous oxide Prisoners

Sites / Locations

  • Albert EinsteinMedical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

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

Arm 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.

The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.

The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.

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.

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.

The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.

Outcomes

Primary Outcome Measures

Measurement of Core Temperature
Core temperature at 15 minute intervals
Temperature Below 36.0 Degrees C
Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia

Secondary Outcome Measures

Measurement of Blood Pressure
Blood pressure decrease after intravenous anesthetic induction

Full Information

First Posted
November 20, 2014
Last Updated
April 12, 2017
Sponsor
Albert Einstein Healthcare Network
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1. Study Identification

Unique Protocol Identification Number
NCT02331108
Brief Title
A Comparison of Inhalation vs. Intravenous Induction
Acronym
INHvsIV
Official Title
A Comparison of the Effect on Temperature Between Patients Induced With Intravenous Propofol vs Inhalation Induction With Sevoflurane
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To compart differences on the effect on core temperature between anesthetic induction with intravenous propofol versus inhalation induction with sevoflurane
Detailed Description
Hypothermia occurs with anesthetic induction due to redistribution hypothermia. Hypothermia has adverse effects and should be avoided or minimized. Intravenous propofol induction is the most common technique used for anesthetic induction. There is preliminary evidence that there is less redistribution hypothermia when anesthetic induction is achieved by inhalation induction compared to intravenous induction. There is not enough data to compel a change in practice patterns. This study will enroll a larger number of patients in order to provide stronger evidence that there is a significant difference between induction techniques on body temperature. Patients will be randomly assigned to two variation of inhalation induction techniques and two variations of intravenous induction. The effect on temperature between the four groups will be compared. Reducing the degree of hypothermia has the potential to decrease surgical infection rate as well as providing other benefits to patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sevoflurane in 100% oxygen, age <56
Arm Type
Active Comparator
Arm 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.
Arm Title
sevoflurane in 50% nitrous, age <56
Arm Type
Active Comparator
Arm Description
The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.
Arm Title
propofol, age <56
Arm Type
Active Comparator
Arm Description
The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.
Arm Title
propofol with phenylephrine, age <56
Arm Type
Active Comparator
Arm Description
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.
Arm Title
sevoflurane in 100% oxygen, age >55
Arm Type
Active Comparator
Arm 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 >55.
Arm Title
sevoflurane in 50% nitrous, age >55
Arm Type
Active Comparator
Arm Description
The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.
Intervention Type
Drug
Intervention Name(s)
Selection of anesthetic induction technique
Other Intervention Name(s)
anesthesia, anesthetic induction, sevoflurane, propofol
Intervention Description
Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes
Primary Outcome Measure Information:
Title
Measurement of Core Temperature
Description
Core temperature at 15 minute intervals
Time Frame
intraoperative
Title
Temperature Below 36.0 Degrees C
Description
Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Measurement of Blood Pressure
Description
Blood pressure decrease after intravenous anesthetic induction
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Elective surgery Adult, age >= 18 years old Scheduled for general anesthesia Medically fit and able to safely go any of the four anesthetic inductions in the study Exclusion Criteria: Emergency surgery, or any other aspiration risk Minor, age <18 Pregnant Febrile illness Contraindication to nasal instrumentation Allergy to propofol Malignant hyperthermia Requiring Total Invravenous Anesthesia (TIVA) Inability to oxygenate on less than 50% FiO2 Intra-cranial surgery Receiving vasoactive medications Significant valvular heart disease Unstable cardiac disease Surgery requiring prone or lateral positioning Contraindication to nitrous oxide Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan V Roth, MD
Organizational Affiliation
Albert Einstein Healthcare Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert EinsteinMedical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31694576
Citation
Roth JV, Braitman LE, Hunt LH. Induction techniques that reduce redistribution hypothermia: a prospective, randomized, controlled, single blind effectiveness study. BMC Anesthesiol. 2019 Nov 6;19(1):203. doi: 10.1186/s12871-019-0866-8. Erratum In: BMC Anesthesiol. 2021 Apr 12;21(1):112.
Results Reference
derived

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A Comparison of Inhalation vs. Intravenous Induction

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