A Comparison of Inhalation vs. Intravenous Induction

Not Applicable

Completed

• Conditions: Hypothermia
• Interventions: Drug: Selection of anesthetic induction technique

• Registration Number: NCT02331108
• Lead Sponsor: Albert Einstein Healthcare Network

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2015-01-02
• Study First Posted: 2015-01-06
• Primary Completion: 2015-10
• Study Completion: 2016-04
• Results First Submitted: 2017-02-06
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-12
• Last Update Submitted: 2017-04-12
• Results First Posted: 2017-04-17
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sevoflurane in 100% oxygen, age <56	Selection of anesthetic induction technique	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.
sevoflurane in 50% nitrous, age <56	Selection of anesthetic induction technique	The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.
propofol, age <56	Selection of anesthetic induction technique	The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.
propofol with phenylephrine, age <56	Selection of anesthetic induction technique	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.
sevoflurane in 100% oxygen, age >55	Selection of anesthetic induction technique	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.
sevoflurane in 50% nitrous, age >55	Selection of anesthetic induction technique	The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age \>55.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Measurement of Blood Pressure	intraoperative	Blood pressure decrease after intravenous anesthetic induction

Trial Locations

Locations (1)

Albert EinsteinMedical Center; 🇺🇸 Philadelphia, Pennsylvania, United States