Actively Recruiting

Phase 2
Phase 3
Age: 20Years - 70Years
All Genders
Healthy Volunteers
ID06740903

Comparison of Dexmedetomidine and Lignocaine Infusions on Perioperative Hemodynamics, Postoperative Pain, and Gastrointestinal Recovery in Laparoscopic Cholecystectomy

Led by Sahiwal medical college sahiwal · Updated on 2024-12-18

140

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

S

Sahiwal medical college sahiwal

Lead Sponsor

D

Department of medical education

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the effects of dexmedetomidine and lignocaine infusions on patients undergoing laparoscopic cholecystectomy, focusing on perioperative hemodynamics, postoperative pain, and gastrointestinal recovery. This randomized controlled trial compares these two drugs to find evidence regarding their impact on reducing opioid-related side effects and managing pain and hemodynamic responses during and after surgery. The study is conducted at Sahiwal Teaching Hospital over 12 months with 140 patients divided into two groups. Participants will be randomly assigned to receive either dexmedetomidine infusion at 0.2-0.4 µg/kg/h or lignocaine infusion at 1-2 mg/kg/h during surgery. All patients undergo standardized anesthesia induction and maintenance, including pre-oxygenation, propofol, nalbuphine, succinylcholine, isoflurane, nitrous oxide, oxygen, and atracurium. Intraoperative monitoring includes heart rate, blood pressure, oxygen saturation, end-tidal CO2, and temperature. Rescue treatments for hypotension and bradycardia are provided as needed. Postoperative care includes pain assessment, opioid use tracking, nausea and vomiting monitoring, and evaluation of gastrointestinal function using the I-FEED scale over 24 hours. Participants will be assessed before surgery, during anesthesia, and for 24 hours postoperatively in the intensive care unit. Heart rate and mean arterial pressure are monitored at several time points during surgery. Postoperative pain is measured with a visual analogue scale, and rescue analgesia is given when pain reaches a specific level. Researchers will record total opioid consumption and recovery of gastrointestinal function at 6, 12, and 24 hours after surgery. All data, including demographics and operative details, are collected systematically to evaluate the effects of the two infusions.

CONDITIONS

Brief Title

Evaluating Perioperative Outcomes: Dexmedetomidine vs Lignocaine in Laparoscopic Chlolecystectomy

Who Can Participate

Age: 20Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 20 to 70 years
  • Both male and female genders
  • Scheduled for laparoscopic cholecystectomy under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I or II
Not Eligible

You will not qualify if you...

  • Emergency surgery cases
  • History of allergic reaction to dexmedetomidine or lignocaine
  • Presence of cardiovascular disease, sickle cell disease, psychiatric disorder, peripheral vascular disease, or neurological diseases
  • Anemia
  • Current use of tricyclic antidepressants or beta blocker medications
  • Uncontrolled hypertension (blood pressure ≥160/100 mmHg)
  • Uncontrolled diabetes mellitus
  • Obesity with body mass index greater than 35

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for preoperative assessment the day before surgery

Treatment

Duration - Duration of surgery

Participants undergo laparoscopic cholecystectomy with anesthesia induction and maintenance. They receive either dexmedetomidine or lignocaine infusion during surgery. Intraoperative monitoring and anesthesia management are performed throughout the surgery.

1 surgical procedure visit (in-person)

Post-operative Follow-up

Duration - 24 hours after surgery

Participants are monitored in the intensive care unit for 24 hours after surgery. Postoperative pain scores and gastrointestinal recovery are assessed. Rescue analgesia is provided if pain scores reach 4 or higher.

Continuous monitoring with assessments at 6, 12, and 24 hours postoperatively

Trial Site Locations

Total: 1 location

1

Sahiwal Medical College Sahiwal

Sahiwal, Punjab Province, Pakistan, 57000

Actively Recruiting

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Research Team

T

Tallal Shahid, MBBS

D

Dr Muhammad Shahid, FCPS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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