The Influence of Genetic Polymorphism on Dose- Dependent Analgesic Response and Safety to Propofol in General Anesthesia

NCT07543523 | Active Not Recruiting DMC

• 1 other identifier: PhDPhrm/Batch-Fall23/2220
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Propofol therapeutic outcomes

  Produces prompt hypnosis (within 40 seconds) and allows for rapid awakening upon discontinuation (10-30 min)

  24 Months

Study Arms (2)

Propofol Group

ACTIVE COMPARATOR

Diagnostic Test: Propofol Group

Isoflurane Group

EXPERIMENTAL

Combination Product: Isoflurane Group

Interventions

Propofol Group DIAGNOSTIC_TEST

Propofol will be administered according to the standard protocol, adjusted to each patient's condition and characteristics

Propofol Group

Isoflurane Group COMBINATION_PRODUCT

Isoflurane will be used as an inhalational aesthetic

Isoflurane Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female \& males aged 18-60yrs
• ASA grade 1 \& II
• Patient enrolled for elective surgery
• BM1 \<35

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 22, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)