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A Comparison of Inhalation vs. Intravenous Induction (INHvsIV)

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ClinicalTrials.gov Identifier: NCT02331108
Recruitment Status : Completed
First Posted : January 6, 2015
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Jonathan Roth, 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

Condition or disease Intervention/treatment Phase
Hypothermia Drug: Selection of anesthetic induction technique Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Comparison of the Effect on Temperature Between Patients Induced With Intravenous Propofol vs Inhalation Induction With Sevoflurane
Actual Study Start Date : August 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: anesthesia, anesthetic induction, sevoflurane, propofol




Primary Outcome Measures :
  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 Outcome Measures :
  1. Measurement of Blood Pressure [ Time Frame: intraoperative ]
    Blood pressure decrease after intravenous anesthetic induction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331108


Locations
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United States, Pennsylvania
Albert EinsteinMedical Center
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Albert Einstein Healthcare Network
Investigators
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Principal Investigator: Jonathan V Roth, MD Albert Einstein Healthcare Network
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonathan Roth, Staff Anesthesiologist, M.D., Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT02331108    
Other Study ID Numbers: HN4613
First Posted: January 6, 2015    Key Record Dates
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation