AnalgesiaNCT07543523
The Influence of Genetic Polymorphism on Dose- Dependent Analgesic Response and Safety to Propofol in General Anesthesia
A study testing Propofol Group and Isoflurane Group in people with Analgesia, run by Superior University at 1 site in Pakistan.
Trial summary
This study investigates the influence of genetic polymorphisms in key drug-metabolizing enzymes-CYP2B6, CYP2C9, and UGT1A9-on the individual response to propofol, a widely used intravenous anesthetic, in patients undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Propofol Group and Isoflurane Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2025to 1 Apr 2027
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female \& males aged 18-60yrs
- ASA grade 1 \& II
- Patient enrolled for elective surgery
- BM1 <35
Who cannot join
- History of drug allergies
- Any chronic disease such as hepatic, psychiatric \& kidney disease.
- History of drug intake (opioids, analgesics)
- History of smoking, alcohol or drug addiction.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
Lahore, Punjab Province
About this study
This study investigates the influence of genetic polymorphisms in key drug-metabolizing enzymes-CYP2B6, CYP2C9, and UGT1A9-on the individual response to propofol, a widely used intravenous anesthetic, in patients undergoing general anesthesia. Despite propofol's fast onset and favorable recovery profile, significant inter-individual variability exists in its dosing requirements, sedation depth, and adverse effects. Such variability is believed to arise in part from genetic differences that affect drug metabolism and action. This research focuses on identifying how specific gene variants, particularly those linked to poor or altered metabolizer phenotypes, influence clinical outcomes like induction time, recovery time, and safety profiles during anesthesia.
Read the detailed description
Focusing on the Pakistani population, this research seeks to fill a gap in regional pharmacogenetic data, which is limited but critical for optimizing patient care. By identifying associations between genetic profiles and anesthetic responses, the findings could support the development of personalized anesthesia protocols, improving drug safety and effectiveness. This project has great potential to advance precision medicine in anesthesiology by enabling more personalized therapeutic strategies that are guided by each patient's distinct genetic makeup.
- Conditions
- Analgesia
- Being tested
- Propofol Group, Isoflurane Group
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol GroupDiagnostic test
Propofol will be administered according to the standard protocol, adjusted to each patient's condition and characteristics
Isoflurane GroupCombination product
Isoflurane will be used as an inhalational aesthetic
| Study group | Role | What they receive |
|---|---|---|
| Propofol Group | Active comparator | Not described Receives: Diagnostic Test: Propofol Group |
| Isoflurane Group | Experimental | Not described Receives: Combination Product: Isoflurane Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol therapeutic outcomes
Produces prompt hypnosis (within 40 seconds) and allows for rapid awakening upon discontinuation (10-30 min)
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Apr 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Superior 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543523
- Sponsor's protocol ID
- PhDPhrm/Batch-Fall23/2220
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Genetic Polymorphism on Dose- Dependent Analgesic Response and Safety to Propofol in General Anesthesia
- ClinicalTrials.gov ID
- NCT07543523
- Acronym / sponsor ID
- PhDPhrm/Batch-Fall23/2220
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 22 Apr 2026 (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 study investigates the influence of genetic polymorphisms in key drug-metabolizing enzymes-CYP2B6, CYP2C9, and UGT1A9-on the individual response to propofol, a widely used intravenous anesthetic, in patients undergoing general anesthesia. Despite propofol's fast onset and favorable recovery profile, significant inter-individual variability exists in its dosing requirements, sedation depth, and adverse effects. Such variability is believed to arise in part from genetic differences that affect drug metabolism and action. This research focuses on identifying how specific gene variants, particularly those linked to poor or altered metabolizer phenotypes, influence clinical outcomes like induction time, recovery time, and safety profiles during anesthesia.
Detailed description
Focusing on the Pakistani population, this research seeks to fill a gap in regional pharmacogenetic data, which is limited but critical for optimizing patient care. By identifying associations between genetic profiles and anesthetic responses, the findings could support the development of personalized anesthesia protocols, improving drug safety and effectiveness. This project has great potential to advance precision medicine in anesthesiology by enabling more personalized therapeutic strategies that are guided by each patient's distinct genetic makeup.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol Group | Active comparator | Diagnostic Test: Propofol Group |
| Isoflurane Group | Experimental | Combination Product: Isoflurane Group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female \& males aged 18-60yrs
- ASA grade 1 \& II
- Patient enrolled for elective surgery
- BM1 <35
Key exclusion criteria (4 listed)
- History of drug allergies
- Any chronic disease such as hepatic, psychiatric \& kidney disease.
- History of drug intake (opioids, analgesics)
- History of smoking, alcohol or drug addiction.
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 GroupPropofol will be administered according to the standard protocol, adjusted to each patient's condition and characteristics | Diagnostic test | Propofol Group |
| Isoflurane GroupIsoflurane will be used as an inhalational aesthetic | Combination product | Isoflurane Group |
Primary outcome
Propofol therapeutic outcomes
Time frame: 24 Months
Produces prompt hypnosis (within 40 seconds) and allows for rapid awakening upon discontinuation (10-30 min)
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 22 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Group and Isoflurane Group in people with Analgesia, run by Superior University at 1 site in Pakistan.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. 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 Pakistan. 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?
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?
Propofol therapeutic outcomes (time frame: 24 Months). 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 22 Apr 2026.