IsofluraneNCT07152912
Impact of Isoflurane and Sevoflurane on Oxidative Stress in Patients Undergoing Laparoscopic Cholecystectomy
A study testing Isoflurane and Sevoflurane in people with Isoflurane and Sevoflurane, run by Ain Shams University at 1 site in Egypt.
Trial summary
The primary aim of this work is to assess the impact of exposure to isoflurane or sevoflurane as an inhalation anesthetic on the oxidative stress and inflammatory conditions in patients undergoing elective moderate invasive surgery (laparoscopic cholecystectomy). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Isoflurane, Sevoflurane, Oxidative Stress
- What is being tested?
- Isoflurane and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Sep 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 20 to 60 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical Status I-II.
- Undergoing elective laparoscopic cholecystectomy under general anesthesia.
Who cannot join
- Refusal of participation in the study by patients.
- Diabetes (type I or II), endocrine system, and immune system diseases.
- Chronic infection and sepsis.
- Cardiac condition as classified bythe New York Heart Association (NYHA) > class II.
- Hepatic disease: INR > 1.5, and/or albumin < 2.5 g/dL.
- Renal disease: glomerular filtration rate (GFR) < 85 ml/min.
- Mental and neurological disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11591
Eman A Ali, Master, 00201008005684, eman.adel@med.asu.edu.eg
Ayman M Kamaly, MD
About this study
Official title: A Comparative Study Between the Impact of Isoflurane and Sevoflurane on Oxidative Stress in Patients Undergoing Laparoscopic Cholecystectomy
The primary aim of this work is to assess the impact of exposure to isoflurane or sevoflurane as an inhalation anesthetic on the oxidative stress and inflammatory conditions in patients undergoing elective moderate invasive surgery (laparoscopic cholecystectomy).
Read the detailed description
Oxidative stress is defined as "an imbalance between oxidants and antioxidants in favour of the oxidants, leading to a disruption of redox signalling and control and/or molecular damage.
Isoflurane, which has been utilized since the 1980s, has a particularly low metabolism rate and solubility, leading to reduced induction of anesthesia during surgery and shortened recovery time after surgery.
Sevoflurane began to be used a decade later and has a lower blood-gas partition coefficient than the other anesthetics, leading to rapid induction of anesthesia and fast awakening after anesthesia.
- Being tested
- Isoflurane, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsofluraneDrug
Patients will receive general anesthesia and maintenance by isoflurane.
SevofluraneDrug
Patients will receive general anesthesia and maintenance by sevoflurane.
| Study group | Role | What they receive |
|---|---|---|
| Group Iso | Experimental | Patients will receive general anesthesia and maintenance by isoflurane. Receives: Drug: Isoflurane |
| Group Sev | Experimental | Patients will receive general anesthesia and maintenance by sevoflurane. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of superoxide dismutase
Serum level of superoxide dismutase (SOD) will be recorded.
Measured: 6 months postoperatively
Secondary outcomes (2)
Serum level of serum soluble programmed cell death-ligand 1
Serum level of serum soluble programmed cell death-ligand 1 (sPD-L1) will be recorded.
Measured: 6 months postoperatively
Serum level of nuclear factor erythroid 2-related factor
Serum level of nuclear factor erythroid 2-related factor (Nrf2) will be recorded.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start4 Sep 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IsofluraneStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman adel ali abd moaty, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152912
- Sponsor's protocol ID
- FMASU MD185/2024
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between the Impact of Isoflurane and Sevoflurane on Oxidative Stress in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07152912
- Acronym / sponsor ID
- FMASU MD185/2024
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 3 Sep 2025 (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.
The primary aim of this work is to assess the impact of exposure to isoflurane or sevoflurane as an inhalation anesthetic on the oxidative stress and inflammatory conditions in patients undergoing elective moderate invasive surgery (laparoscopic cholecystectomy).
Detailed description
Oxidative stress is defined as "an imbalance between oxidants and antioxidants in favour of the oxidants, leading to a disruption of redox signalling and control and/or molecular damage.
Isoflurane, which has been utilized since the 1980s, has a particularly low metabolism rate and solubility, leading to reduced induction of anesthesia during surgery and shortened recovery time after surgery.
Sevoflurane began to be used a decade later and has a lower blood-gas partition coefficient than the other anesthetics, leading to rapid induction of anesthesia and fast awakening after anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Iso | Experimental | Drug: IsofluranePatients will receive general anesthesia and maintenance by isoflurane. |
| Group Sev | Experimental | Drug: SevofluranePatients will receive general anesthesia and maintenance by sevoflurane. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 20 to 60 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical Status I-II.
- Undergoing elective laparoscopic cholecystectomy under general anesthesia.
Key exclusion criteria (7 listed)
- Refusal of participation in the study by patients.
- Diabetes (type I or II), endocrine system, and immune system diseases.
- Chronic infection and sepsis.
- Cardiac condition as classified bythe New York Heart Association (NYHA) > class II.
- Hepatic disease: INR > 1.5, and/or albumin < 2.5 g/dL.
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 |
|---|---|---|
| IsofluranePatients will receive general anesthesia and maintenance by isoflurane. | Drug | Group Iso |
| SevofluranePatients will receive general anesthesia and maintenance by sevoflurane. | Drug | Group Sev |
Primary outcome
Serum level of superoxide dismutase
Time frame: 6 months postoperatively
Serum level of superoxide dismutase (SOD) will be recorded.
2 secondary outcomes
Serum level of serum soluble programmed cell death-ligand 1
Time frame: 6 months postoperatively
Serum level of nuclear factor erythroid 2-related factor
Time frame: 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Isoflurane
RecruitingPhase 4
Anesthesia and Non-small Cell Lung Cancer Recurrence
Non-small Cell Lung Cancer, Surgery
Not yet recruiting
Comparison of Two Sedative Agents in Terms of Controlled Hypotension
Controlled Hypotension for Nasal Surgeries
RecruitingPhase 3
Sevoflurane/Dexmedetomidine vs. Isoflurane for Pediatric Emergence Delirium
Delirium on Emergence
Not yet recruitingPhase 3
Inhaled Isoflurane for Sedation of Invasively Ventilated Patients With Cardiogenic Shock on Extracorporeal Membrane Oxygenation
Cardiogenic Shock, ECMO
Active, not recruitingPhase 3
A Pooled Analysis of Long-Term Outcomes After Inhaled Isoflurane Via the Sedaconda ACD-S Compared to Intravenous Propofol
Post-Intensive Care Syndrome, Sedation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoflurane and Sevoflurane in people with Isoflurane and Sevoflurane, run by Ain Shams 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 4 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: looking for participants now, as of the sponsor's last update on 5 Sep 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman A Ali, Master (00201008005684, eman.adel@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum level of superoxide dismutase (time frame: 6 months postoperatively). 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 Sep 2025.