A Comparison of Inhalation vs. Intravenous Induction

Hypothermia Clinical Trial

— INHvsIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331108
• Other study ID #: HN4613
• Status: Completed
• Phase: N/A
• First received: November 20, 2014
• Last updated: April 12, 2017
• Start date: August 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2017
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia

Intervention

Drug:
• Selection of anesthetic induction technique
Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes

Locations

Country	Name	City	State
United States	Albert EinsteinMedical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Core Temperature	Core temperature at 15 minute intervals	intraoperative
Primary	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	Measurement of Blood Pressure	Blood pressure decrease after intravenous anesthetic induction	intraoperative