Induction of General AnesthesiaNCT05105022
Propofol Versus Sevoflurane for Induction of GA in Infants
A study testing Propofol in people with Induction of General Anesthesia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 90 days
- Conditions the study is for
- Induction of General Anesthesia
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants aged 3 months or less scheduled for elective surgery
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine- Cairo University
Cairo, 11562
Shymaa Fathy, MD, 23649281 ext. 002, pg@kasralainy.edu.eg
About this study
Official title: The Hemodynamic Effects of Propofol Versus Sevoflurane for Induction of Anesthesia in Healthy Infants as Measured by Electrical Cardiometry: Randomized Controlled Trial
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.
Read the detailed 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
- Conditions
- Induction of General Anesthesia
- Being tested
- Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Intravenous induction of general anesthesia in infants 3 months or less.
| Study group | Role | What they receive |
|---|---|---|
| propofol | Experimental | Propofol at a dose of 2mg/kg will be administered I.V. . Receives: Drug: Propofol |
| Sevoflurane | Active comparator | Sevoflurane (4%) will be used for inhalational induction. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac index
L/min/m2
Measured: 15 minutes
Secondary outcomes (1)
MAP
mmHg
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Oct 2021
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa Fathy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105022
- Sponsor's protocol ID
- Ms_203_2021
- Status last verified
- Jul 2023
- First submitted
- 25 Sep 2021
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hemodynamic Effects of Propofol Versus Sevoflurane for Induction of Anesthesia in Healthy Infants as Measured by Electrical Cardiometry: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05105022
- Acronym / sponsor ID
- Ms_203_2021
- Conditions
- Induction of General Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Experimental | Drug: PropofolPropofol at a dose of 2mg/kg will be administered I.V. . |
| Sevoflurane | Active comparator | Drug: PropofolSevoflurane (4%) will be used for inhalational induction. |
Who may qualify
- Ages
- 1 day to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants aged 3 months or less scheduled for elective surgery
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolIntravenous induction of general anesthesia in infants 3 months or less. | Drug | Sevoflurane, propofol |
Primary outcome
cardiac index
Time frame: 15 minutes
L/min/m2
1 secondary outcome
MAP
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol in people with Induction of General Anesthesia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shymaa Fathy, MD (+201000455897 ext. 002, angel6122003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac index (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.