A Comparison of Inhalation vs. Intravenous Induction (INHvsIV)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02331108 |
Recruitment Status :
Completed
First Posted : January 6, 2015
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
|
|||
Original Primary Outcome Measures ICMJE |
Measurement of core temperature [ Time Frame: intraoperative ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Measurement of Blood Pressure [ Time Frame: intraoperative ] Blood pressure decrease after intravenous anesthetic induction
|
|||
Original Secondary Outcome Measures ICMJE |
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 |
|
|||
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 |
331 | |||
Original Estimated Enrollment ICMJE |
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 |
|
|||
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 |
|
|||
Current Responsible Party | Jonathan Roth, Albert Einstein Healthcare Network | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Albert Einstein Healthcare Network | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
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 |