Comparing Propofol and Sevoflurane for Anesthesia in Infants
The Hemodynamic Effects of Propofol Versus Sevoflurane for Induction of Anesthesia in Healthy Infants as Measured by Electrical Cardiometry: Randomized Controlled Trial
This study is testing whether propofol is safer than sevoflurane for giving anesthesia to infants under 3 months old during surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 1 Day to 90 Days |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05105022 on ClinicalTrials.gov |
What this trial studies
This study investigates the hemodynamic safety of propofol compared to sevoflurane for inducing general anesthesia in infants aged 3 months or less. The approach utilizes electrical cardiometry to assess the hemodynamic effects during anesthesia induction. The hypothesis is that propofol will demonstrate a safer hemodynamic profile and favorable pharmacokinetics, leading to rapid induction and optimal intubation conditions. The study is conducted at Abu Al Reesh Children's Hospital, Faculty of Medicine, Cairo University, following an institutional protocol.
Who should consider this trial
Good fit: Ideal candidates are infants aged 3 months or less who are scheduled for elective surgery.
Not a fit: Patients with significant structural congenital heart disease, intracranial malformations, or preexisting hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and efficacy of anesthesia induction in very young infants.
How similar studies have performed: While there have been studies on anesthesia induction in infants, this specific comparison of propofol and sevoflurane using electrical cardiometry is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Cairo
- Faculty of Medicine- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Shymaa Fathy, MD
- Email: angel6122003@yahoo.com
- Phone: +201000455897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.