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History of Changes for Study: NCT02331108
A Comparison of Inhalation vs. Intravenous Induction (INHvsIV)
Latest version (submitted April 12, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 2, 2015 None (earliest Version on record)
2 January 4, 2016 Recruitment Status, Study Status and Contacts/Locations
3 April 12, 2017 Recruitment Status, Study Status, Arms and Interventions, Outcome Measures, Study Design, Results, IPDSharing and Contacts/Locations
Comparison Format:

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Study NCT02331108
Submitted Date:  January 2, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: HN4613
Brief Title: A Comparison of Inhalation vs. Intravenous Induction (INHvsIV)
Official Title: A Comparison of the Effect on Temperature Between Patients Induced With Intravenous Propofol vs Inhalation Induction With Sevoflurane
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2015
Overall Status: Recruiting
Study Start: August 2014
Primary Completion: December 2015 [Anticipated]
Study Completion: December 2015 [Anticipated]
First Submitted: November 20, 2014
First Submitted that
Met QC Criteria:
January 2, 2015
First Posted: January 6, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 2, 2015
Last Update Posted: January 6, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Albert Einstein Healthcare Network
Responsible Party: Principal Investigator
Investigator: Jonathan Roth
Official Title: Staff Anesthesiologist, M.D.
Affiliation: Albert Einstein Healthcare Network
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Hypothermia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: sevoflurane in 100% oxygen
Patients with undergo inhalation anesthetic induction with sevoflurane in 100% oxygen
Measurement of temperature
Standard anesthesia care will be provided after induction. Temperatures will be monitored every 15 minutes
Active Comparator: sevoflurane in 50% nitrous oxide
Patients with undergo inhalation anesthetic induction with sevoflurane in 50% oxygen and 50% nitrous oxide
Measurement of temperature
Standard anesthesia care will be provided after induction. Temperatures will be monitored every 15 minutes
Active Comparator: propofol
Patients will be intraveously induced with 2.2 mg/kg propofol
Measurement of temperature
Standard anesthesia care will be provided after induction. Temperatures will be monitored every 15 minutes
Active Comparator: propofol with phenylephrine
Patients will be intraveously induced with 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine
Measurement of temperature
Standard anesthesia care will be provided after induction. Temperatures will be monitored every 15 minutes
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Measurement of core temperature
[ Time Frame: intraoperative ]

Secondary Outcome Measures:
1. Measurement of blood pressure
[ Time Frame: intraoperative ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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

Open or close this module Contacts/Locations
Locations: United States, Pennsylvania
Albert EinsteinMedical Center
[Recruiting]
Philadelphia, Pennsylvania, United States, 19141
Contact:Contact: Jonathan V Roth, MD 215-456-7979 rothj@einstein.edu
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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