A Comparison of Inhalation vs. Intravenous Induction (INHvsIV)

• 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: Albert Einstein Healthcare Network
• Information provided by (Responsible Party): Jonathan Roth, Albert Einstein Healthcare Network

Tracking Information

• First Submitted Date: November 20, 2014
• First Posted Date: January 6, 2015
• Results First Submitted Date: February 6, 2017
• Results First Posted Date: April 17, 2017
• Last Update Posted Date: April 17, 2017
• Actual Study Start Date: August 2014
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: January 2, 2015): Measurement of core temperature [ Time Frame: intraoperative ]

Current Secondary Outcome Measures (submitted: April 12, 2017)

Measurement of Blood Pressure [ Time Frame: intraoperative ]

Blood pressure decrease after intravenous anesthetic induction

• Original Secondary Outcome Measures (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: A Comparison of Inhalation vs. Intravenous Induction
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Hypothermia

Intervention

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 12, 2017): 331
• Original Estimated Enrollment (submitted: January 2, 2015): 300
• Actual Study Completion Date: April 2016
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02331108
• Other Study ID Numbers: HN4613
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Jonathan Roth, Albert Einstein Healthcare Network
• Original Responsible Party: Same as current
• Current Study Sponsor: Albert Einstein Healthcare Network
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jonathan V Roth, MD; Albert Einstein Healthcare Network

• PRS Account: Albert Einstein Healthcare Network
• Verification Date: April 2017