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Trial record 1 of 1 for:    NCT02331108
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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

Tracking Information
First Submitted Date  ICMJE November 20, 2014
First Posted Date  ICMJE January 6, 2015
Results First Submitted Date  ICMJE February 6, 2017
Results First Posted Date  ICMJE April 17, 2017
Last Update Posted Date April 17, 2017
Actual Study Start Date  ICMJE August 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
  • Measurement of Core Temperature [ Time Frame: intraoperative ]
    Core temperature at 15 minute intervals
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 2, 2015)
Measurement of Core Temperature [ Time Frame: intraoperative ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
Measurement of Blood Pressure [ Time Frame: intraoperative ]
Blood pressure decrease after intravenous anesthetic induction
Original Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2015)
Measurement of Blood Pressure [ Time Frame: intraoperative ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Inhalation vs. Intravenous Induction
Official Title  ICMJE A Comparison of the Effect on Temperature Between Patients Induced With Intravenous Propofol vs Inhalation Induction With Sevoflurane
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hypothermia
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Selection of anesthetic induction technique
  • 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.
    Intervention: Drug: Selection of anesthetic induction technique
  • 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.
    Intervention: Drug: Selection of anesthetic induction technique
  • 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.
    Intervention: Drug: Selection of anesthetic induction technique
  • 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.
    Intervention: Drug: Selection of anesthetic induction technique
  • 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.
    Intervention: Drug: Selection of anesthetic induction technique
Publications * Roth JV, Braitman LE, Hunt LH. Induction techniques that reduce redistribution hypothermia: a prospective, randomized, controlled, single blind effectiveness study. BMC Anesthesiol. 2019 Nov 6;19(1):203. doi: 10.1186/s12871-019-0866-8. Erratum in: BMC Anesthesiol. 2021 Apr 12;21(1):112.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2017)
331
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2015)
300
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02331108
Other Study ID Numbers  ICMJE HN4613
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jonathan Roth, Albert Einstein Healthcare Network
Study Sponsor  ICMJE Albert Einstein Healthcare Network
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan V Roth, MD Albert Einstein Healthcare Network
PRS Account Albert Einstein Healthcare Network
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP