A Comparison of Inhalation vs. Intravenous Induction (INHvsIV)

Albert Einstein Healthcare Network

Status: Completed

Conditions: Hypothermia

Treatments: Drug: Selection of anesthetic induction technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02331108

HN4613

Details and patient eligibility

About

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

Full 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.

Enrollment: 331 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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331 participants in 6 patient groups

sevoflurane in 100% oxygen, age <56

Active Comparator group

Description:

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.

Treatment:

Drug: Selection of anesthetic induction technique

sevoflurane in 50% nitrous, age <56

Active Comparator group

Description:

The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.

Treatment:

Drug: Selection of anesthetic induction technique

propofol, age <56

Active Comparator group

Description:

The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.

Treatment:

Drug: Selection of anesthetic induction technique

propofol with phenylephrine, age <56

Active Comparator group

Description:

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.

Treatment:

Drug: Selection of anesthetic induction technique

sevoflurane in 100% oxygen, age >55

Active Comparator group

Description:

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.

Treatment:

Drug: Selection of anesthetic induction technique

sevoflurane in 50% nitrous, age >55

Active Comparator group

Description:

The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age \>55.

Treatment:

Drug: Selection of anesthetic induction technique