General Anesthetic Drug Adverse ReactionPhase 4NCT05935930
Postoperative Effects of Propofol Versus Sevoflurane Anesthesia
A Phase 4 study testing Propofol 10 MG/ML Injection and Sevoflurane Inhalation Liquid in people with General Anesthetic Drug Adverse Reaction, run by Damanhour Teaching Hospital at 1 site in Egypt.
Trial summary
Background: The choice of appropriate anesthetics is essential to protect brain function, decrease perioperative complications, and provide high-quality care, and better quality of life. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- General Anesthetic Drug Adverse Reaction
- What is being tested?
- Propofol 10 MG/ML Injection and Sevoflurane Inhalation Liquid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 15 Dec 2024
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 years
- Body Mass Index (BMI) 25-35 kg/m2
Who cannot join
- ASA physical status > II
- Age < 21 years
- Patients with Montreal Objective Cognitive Assessment (MoCA-B) score < 24 points
- Patients with significant cardiovascular, cerebrovascular, respiratory, liver, renal, endocrine, blood, or immune diseases
- Patients with visual or auditory disease, infection, chronic inflammation, disturbance of consciousness, cognitive impairment, or dementia
- Patients on long-term use of sedatives or steroids, alcohol or drug abuse
- Allergy to any of the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Effects of Propofol Versus Sevoflurane Anesthesia During Elective Non-Cardiac Surgeries. A Randomized Clinical Trial
Background: The choice of appropriate anesthetics is essential to protect brain function, decrease perioperative complications, and provide high-quality care, and better quality of life.
Objectives: To compare the efficacy and safety of propofol versus sevoflurane in patients undergoing elective, non-cardiac operations under general anesthesia.
Methods: This was a randomized (1:1), parallel, phase four clinical trial; carried out on 44 patients, who were candidates for elective, non-cardiac operations under general anesthesia at our hospital. Patients were randomly allocated into two equal groups in which anesthesia was maintained with propofol infusion in group P and sevoflurane inhalation in group S.
- Conditions
- General Anesthetic Drug Adverse Reaction
- Being tested
- Propofol 10 MG/ML Injection, Sevoflurane Inhalation Liquid
- Keywords
- Cognitive function, General anesthesia, Inflammatory response, Oxidative stress, Propofol, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol 10 MG/ML InjectionDrug
Propofol infusion
Sevoflurane Inhalation LiquidDrug
Sevoflurane inhalation
| Study group | Role | What they receive |
|---|---|---|
| Group P (n=22) | Active comparator | Propofol group Receives: Drug: Propofol 10 MG/ML Injection |
| Group S (n=22) | Active comparator | Sevoflurane group Receives: Drug: Sevoflurane Inhalation Liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and Standard deviation of Neuron Specific Enolase enzyme (µg/L) in blood serum (mean±SD)
Before operation (T0), 1 hour after the end of operation (T1), 24 hours the end of operation (T2)
Measured: 24 hours after the end of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Dec 2021
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthetic Drug Adverse ReactionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ahmed M Shaat, MD, Principal investigator, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935930
- Sponsor's protocol ID
- DTH: 22004
- Status last verified
- Jan 2024
- First submitted
- 27 Jun 2023
- Last updated
- 5 Feb 2025
- 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 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Effects of Propofol Versus Sevoflurane Anesthesia During Elective Non-Cardiac Surgeries. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05935930
- Acronym / sponsor ID
- DTH: 22004
- Conditions
- General Anesthetic Drug Adverse Reaction
- Keywords
- Cognitive function, General anesthesia, Inflammatory response, Oxidative stress, Propofol, Sevoflurane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Damanhour Teaching HospitalOther government
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 7 Jul 2023 (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.
Background: The choice of appropriate anesthetics is essential to protect brain function, decrease perioperative complications, and provide high-quality care, and better quality of life.
Objectives: To compare the efficacy and safety of propofol versus sevoflurane in patients undergoing elective, non-cardiac operations under general anesthesia.
Methods: This was a randomized (1:1), parallel, phase four clinical trial; carried out on 44 patients, who were candidates for elective, non-cardiac operations under general anesthesia at our hospital. Patients were randomly allocated into two equal groups in which anesthesia was maintained with propofol infusion in group P and sevoflurane inhalation in group S.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P (n=22) | Active comparator | Drug: Propofol 10 MG/ML InjectionPropofol group |
| Group S (n=22) | Active comparator | Drug: Sevoflurane Inhalation LiquidSevoflurane group |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 years
- Body Mass Index (BMI) 25-35 kg/m2
Key exclusion criteria (7 listed)
- ASA physical status > II
- Age < 21 years
- Patients with Montreal Objective Cognitive Assessment (MoCA-B) score < 24 points
- Patients with significant cardiovascular, cerebrovascular, respiratory, liver, renal, endocrine, blood, or immune diseases
- Patients with visual or auditory disease, infection, chronic inflammation, disturbance of consciousness, cognitive impairment, or dementia
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 |
|---|---|---|
| Propofol 10 MG/ML InjectionPropofol infusion | Drug | Group P (n=22) |
| Sevoflurane Inhalation LiquidSevoflurane inhalation | Drug | Group S (n=22) |
Primary outcome
Mean and Standard deviation of Neuron Specific Enolase enzyme (µg/L) in blood serum (mean±SD)
Time frame: 24 hours after the end of operation
Before operation (T0), 1 hour after the end of operation (T1), 24 hours the end of operation (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
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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.
Ahmed M Shaat, MD principal investigator
Damanhour Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol 10 MG/ML Injection and Sevoflurane Inhalation Liquid in people with General Anesthetic Drug Adverse Reaction, run by Damanhour Teaching Hospital 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 5 Feb 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean and Standard deviation of Neuron Specific Enolase enzyme (µg/L) in blood serum (mean±SD) (time frame: 24 hours after the end of operation). 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 Feb 2025.