NCT05105022

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

September 25, 2021

Last Update Submit

July 2, 2023

Conditions

Induction of General Anesthesia

Outcome Measures

Primary Outcomes (1)

  • cardiac index

    L/min/m2

    15 minutes

Secondary Outcomes (1)

  • MAP

    15 minutes

Study Arms (2)

propofol

EXPERIMENTAL

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

Drug: Propofol

Sevoflurane

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

PropofolDRUG

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

Sevofluranepropofol

Eligibility Criteria

Age1 Day - 90 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • infants aged 3 months or less scheduled for elective surgery

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine- Cairo University

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Shymaa Fathy, MD

CONTACT

+201000455897angel6122003@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and SICU

Study Record Dates

First Submitted

September 25, 2021

First Posted

November 3, 2021

Study Start

October 1, 2021

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

July 5, 2023

Record last verified: 2023-07

Locations

EG(1)