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OpenTrials
Completed

NCT Number: NCT02331108

A Comparison of Inhalation vs. Intravenous Induction

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert EinsteinMedical Center

Philadelphia, Pennsylvania, 19141, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selection of anesthetic induction technique

Drug

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

Primary outcomes

  1. Measurement of Core Temperature

    Time frame: intraoperative

    Core temperature at 15 minute intervals

  2. Temperature Below 36.0 Degrees C

    Time frame: Intraoperative

    Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia

Secondary outcomes

  1. Measurement of Blood Pressure

    Time frame: intraoperative

    Blood pressure decrease after intravenous anesthetic induction

Sponsors and collaborators

Lead sponsor

Albert Einstein Healthcare Network

Other

Registry information

Official study title

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

Acronym: INHvsIV

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jan 6, 2015
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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