A Comparison of Inhalation vs. Intravenous Induction

NCT02331108 | Completed Results

• 1 other identifier: HN4613
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 1

Brief Summary

To compart differences on the effect on core temperature between anesthetic induction with intravenous propofol versus inhalation induction with sevoflurane

Conditions

Hypothermia

Outcome Measures

Primary Outcomes (2)

• Measurement of Core Temperature

  Core temperature at 15 minute intervals

  intraoperative

• Temperature Below 36.0 Degrees C

  Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia

  Intraoperative

Secondary Outcomes (1)

• Measurement of Blood Pressure

  intraoperative

Study Arms (6)

sevoflurane in 100% oxygen, age <56

ACTIVE COMPARATOR

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

sevoflurane in 50% nitrous, age <56

ACTIVE COMPARATOR

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

propofol, age <56

ACTIVE COMPARATOR

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

propofol with phenylephrine, age <56

ACTIVE COMPARATOR

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

sevoflurane in 100% oxygen, age >55

ACTIVE COMPARATOR

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

sevoflurane in 50% nitrous, age >55

ACTIVE COMPARATOR

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

Interventions

Selection of anesthetic induction technique DRUG

Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes

Also known as: anesthesia, anesthetic induction, sevoflurane, propofol

propofol with phenylephrine, age <56; propofol, age <56; sevoflurane in 100% oxygen, age <56; sevoflurane in 100% oxygen, age >55; sevoflurane in 50% nitrous, age <56; sevoflurane in 50% nitrous, age >55

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert EinsteinMedical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (1)

• 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.

  PMID: 31694576 DERIVED

MeSH Terms

Conditions

Hypothermia

Interventions

Anesthesia; Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Jonathan Roth, M.D.
• Organization: Albert Einstein Healthcare Network

rothj@einstein.edu

2154567979

Study Officials

• Jonathan V Roth, MD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist, M.D.

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: January 6, 2015
• Study Start: August 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2016
• Last Updated: April 17, 2017
• Results First Posted: April 17, 2017

Record last verified: 2017-04

Locations

US (1)