A Comparison of Inhalation vs. Intravenous Induction (INHvsIV)

A Comparison of the Effect on Temperature Between Patients Induced With Intravenous Propofol vs Inhalation Induction With Sevoflurane

To compart differences on the effect on core temperature between anesthetic induction with intravenous propofol versus inhalation induction with sevoflurane

Study Overview

• Status: Completed
• Conditions: Hypothermia
• Intervention / Treatment: Drug: Selection of anesthetic induction technique

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.

• Study Type: Interventional
• Enrollment (Actual): 331
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert EinsteinMedical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Selection of anesthetic induction technique; Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes; Other Names: anesthesia, anesthetic induction, sevoflurane, propofol
Active Comparator: 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.	Drug: Selection of anesthetic induction technique; Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes; Other Names: anesthesia, anesthetic induction, sevoflurane, propofol
Active Comparator: 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.	Drug: Selection of anesthetic induction technique; Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes; Other Names: anesthesia, anesthetic induction, sevoflurane, propofol
Active Comparator: 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.	Drug: Selection of anesthetic induction technique; Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes; Other Names: anesthesia, anesthetic induction, sevoflurane, propofol
Active Comparator: 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.	Drug: Selection of anesthetic induction technique; Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes; Other Names: anesthesia, anesthetic induction, sevoflurane, propofol
Active Comparator: 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.	Drug: Selection of anesthetic induction technique; Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes; Other Names: anesthesia, anesthetic induction, sevoflurane, propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Core Temperature	Core temperature at 15 minute intervals	intraoperative
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	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Blood Pressure	Blood pressure decrease after intravenous anesthetic induction	intraoperative

Collaborators and Investigators

• Sponsor: Albert Einstein Healthcare Network
• Investigators: Principal Investigator: Jonathan V Roth, MD, Albert Einstein Healthcare Network

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: November 20, 2014
• First Submitted That Met QC Criteria: January 2, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Actual): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Anesthetics; Propofol; Sevoflurane
• Other Study ID Numbers: HN4613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided