Overview

This trial is active, not recruiting.

Condition hypothermia
Treatment measurement of temperature
Sponsor Albert Einstein Healthcare Network
Start date August 2014
End date October 2015
Trial size 300 participants
Trial identifier NCT02331108, HN4613

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Patients with undergo inhalation anesthetic induction with sevoflurane in 100% oxygen
measurement of temperature
Standard anesthesia care will be provided after induction. Temperatures will be monitored every 15 minutes
(Active Comparator)
Patients with undergo inhalation anesthetic induction with sevoflurane in 50% oxygen and 50% nitrous oxide
measurement of temperature
Standard anesthesia care will be provided after induction. Temperatures will be monitored every 15 minutes
(Active Comparator)
Patients will be intraveously induced with 2.2 mg/kg propofol
measurement of temperature
Standard anesthesia care will be provided after induction. Temperatures will be monitored every 15 minutes
(Active Comparator)
Patients will be intraveously induced with 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine
measurement of temperature
Standard anesthesia care will be provided after induction. Temperatures will be monitored every 15 minutes

Primary Outcomes

Measure
Measurement of core temperature
time frame: intraoperative

Secondary Outcomes

Measure
Measurement of blood pressure
time frame: intraoperative

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Comparison of the Effect on Temperature Between Patients Induced With Intravenous Propofol vs 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Albert Einstein Healthcare Network.