Propofol Versus Sevoflurane for Induction of GA in Infants

Cairo University (CU)

Status: Enrolling

Conditions: Induction of General Anesthesia

Treatments: Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05105022

Ms_203_2021

Details and patient eligibility

About

This comparative study aims to investigate the haemodynamic safety profile for induction of general anesthesia in infants 3 months or less guided by electrical cardiometry parameters versus sevoflurane.

Full description

This study aims to investigate the hemodynamic effects of both propofol and sevoflurane for induction of anesthesia in infants less than 3 months of age by electrical cardiometry. The investigators hypothesized that propofol will have a safe hemodynamic profile for induction of anesthesia in infants less than 3 months of age as measured by electrical cardiometry in addition to its favorable pharmacokinetic profile of rapid induction and optimal intubation conditions.It is conducted at Abu Al Reesh Children's Hospital, Faculty of Medicine, Cairo University based on an institutional protocol used as a standard of care to induce anesthesia

Enrollment: 122 estimated patients

Sex: All

Ages: 1 to 90 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• infants aged 3 months or less scheduled for elective surgery

Exclusion criteria

• significant structural congenital heart disease
• intracranial malformation.
• preexisting hemodynamic instability.
• history of seizures, opioids, and/or hypnotic administration.
• prematurity (defined as gestational age <37 weeks)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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122 participants in 2 patient groups

propofol

Experimental group

Description:

Propofol at a dose of 2mg/kg will be administered I.V. .

Treatment:

Drug: Propofol

Sevoflurane

Active Comparator group

Description:

Sevoflurane (4%) will be used for inhalational induction.

Treatment:

Drug: Propofol