A Comparison of Inhalation vs. Intravenous Induction

NCT ID: NCT02331108

Last Updated: 2017-04-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

331 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Selection of anesthetic induction technique

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Selection of anesthetic induction technique

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Selection of anesthetic induction technique

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Selection of anesthetic induction technique

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Selection of anesthetic induction technique

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Selection of anesthetic induction technique

Intervention Type DRUG

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

Interventions

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Selection of anesthetic induction technique

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

Intervention Type DRUG

Other Intervention Names

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anesthesia, anesthetic induction, sevoflurane, propofol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Albert Einstein Healthcare Network

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Roth

Staff Anesthesiologist, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan V Roth, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein Healthcare Network

Locations

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Albert EinsteinMedical Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31694576 (View on PubMed)

Other Identifiers

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HN4613

Identifier Type: -

Identifier Source: org_study_id

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