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Exploring the Impact of Genetic Variations on The Clinical Efficacy of Nalbuphine in Postoperative Pain Management

Status: Recruiting
Location: See location...
Intervention Type: Genetic, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The goal of this study is to identify the genes as well as their association with Nalbuphine. This will help the investigator to identify opioid vulnerability in Pakistani population in the postoperative patients and will contribute to overcoming the opioid crisis, resulting in better and safer outcomes. Research question is: Is there any association between the underlying genetic variations and the analgesic efficacy of Nalbuphine in postoperative patients? The Research Objectives are 1. To identify the underlying genes in postoperative patients having pain. 2. To find an association between identified genes and nalbuphine clinical efficacy. Procedure: After the written informed consent adult men and women will be enrolled in the study. On the day of surgery in the preoperative area, a 5 ml blood sample will be drawn before surgery and will be sent to laboratory for analysis. After routine hemodynamic monitoring in the operative room, general anesthesia will be given including nalbuphine. Standard routine anesthesia monitoring will be done and maintained while monitoring heart rate, ECG, NIBP oxygen saturation, ETCO2 and temperature. Incremental analgesia will be provided whenever needed. After extubation and shifting to recovery room the 2nd sample of blood will be taken and will be sent for analysis. Pain score, nausea vomiting, sedation, requirement of analgesia will be assessed till 24 hours postoperatively.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• All adult men or women

• Age 18 to 70 years

• ASA criteria 1,2 and 3

• Abdomino-pelvic surgeries (open hernia repair, appendicectomy, open cholecystectomy, laparotomy, hysterectomy, cystectomy) lasting 2-4 hours

Locations
Other Locations
Pakistan
Ziauddin University
RECRUITING
Karachi
Contact Information
Primary
Asma Abdus Salam, FCPS, MCPS, MBBS
asma.salam.azhar@gmail.com
+923002122264
Backup
Zulfiqar Omrani, Director ORIC
director.oric@zu.edu.pk
+9235862937
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 263
Treatments
Experimental: nalbuphine
Given as intravenously, 0.1-0.2 mg / kg at induction and intermittently
Sponsors
Leads: Dr. Asma Abdus Salam

This content was sourced from clinicaltrials.gov

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