Propofol Versus Sevoflurane for Induction of GA in Infants

NCT ID: NCT05105022

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Induction of General Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

propofol

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Intravenous induction of general anesthesia in infants 3 months or less.

Sevoflurane

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Intravenous induction of general anesthesia in infants 3 months or less.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Propofol

Intravenous induction of general anesthesia in infants 3 months or less.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

1 Day

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shymaa Fathy

Lecturer of anesthesia and SICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine- Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shymaa Fathy, MD

Role: CONTACT

+201000455897 ext. 002

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shymaa Fathy, MD

Role: primary

23649281 ext. 002

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ms_203_2021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Emergence Agitation of Sevoflurane in Pediatric
NCT06830564 COMPLETED PHASE2/PHASE3
Ketamine Versus Propofol as ICU Sedation
NCT06243822 COMPLETED PHASE4
Propofol in Emergence Agitation
NCT00535613 COMPLETED PHASE4