- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07543523
The Influence of Genetic Polymorphism on Dose- Dependent Analgesic Response and Safety to Propofol in General Anesthesia
April 15, 2026 updated by: Muhammad Naveed Babur, Superior University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
159
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Female & males aged 18-60yrs
- ASA grade 1 & II
- Patient enrolled for elective surgery
- BM1 <35
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Propofol Group
|
Propofol will be administered according to the standard protocol, adjusted to each patient's condition and characteristics
|
|
Experimental: Isoflurane Group
|
Isoflurane will be used as an inhalational aesthetic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Propofol therapeutic outcomes
Time Frame: 24 Months
|
Produces prompt hypnosis (within 40 seconds) and allows for rapid awakening upon discontinuation (10-30 min)
|
24 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
April 8, 2026
First Submitted That Met QC Criteria
April 15, 2026
First Posted (Actual)
April 22, 2026
Study Record Updates
Last Update Posted (Actual)
April 22, 2026
Last Update Submitted That Met QC Criteria
April 15, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PhDPhrm/Batch-Fall23/2220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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