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Clinical Trials/NCT06231992
NCT06231992
Not yet recruiting
Not Applicable

Comparative Study Between Opioid Free Anaesthesia Versus Opioid Based Anesthesia for Laparscopic Cholecystectomy

Al-Azhar University0 sites60 target enrollmentJanuary 31, 2024
ConditionsOpioid Use

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Use
Sponsor
Al-Azhar University
Enrollment
60
Primary Endpoint
Visual analogue score
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

The aim of this study is to compare the efficacy of Opioid-free anesthesia (OFA) with opioid anaesthesia (OA) in patients undergoing laparoscopic cholecystectomy (LC).

Detailed Description

Laparoscopic Cholecystectomy (LC) is a standard surgical procedure for cholelithiasis and gallstone disease, became rapidly the procedure of choice for gallbladder disease and It decreases postoperative pain, decreases the need for postoperative analgesia, shortens the hospital stay, and returns the patient to full activity within 1 week (compared with 1 month after open cholecystectomy). LC also provides less scars and improved patient satisfaction as compared with open cholecystectomy Pneumoperitoneum is created using Carbon dioxide, and a camera and dissecting instruments are introduced in the abdominal cavity. Initiation and maintenance of pneumoperitoneum cause hemodynamic stress, which is attenuated by adequate anesthesia depth and often multimodal analgesia. Although laparoscopic cholecystectomy is a standard minimally invasive surgical procedure, some patients may have significant morbidity in the first 24 to 72 hours during the postoperative period Opioids are commonly used for intraoperative analgesia and sedation during general anesthesia and are among the most widely used agents for treating acute pain in the immediate postoperative period. Opioids are known to provide adequate analgesia and stable intraoperative hemodynamics, which are the most critical concerns during the perioperative period. Although opioids are an essential constituent of balanced anesthesia, their use has been questioned due to severe and significant adverse effects Moreover, the availability of potent opioids in low-resource settings is also a remarkable challenge. To tackle this situation several suitable alternatives were explored. Preemptive and multimodal analgesia is an established care model that minimizes perioperative opioid consumption, thereby minimizing adverse effects and promoting positive outcomes after surgery These techniques combine the pharmacologic effects of multiple analgesics to achieve a synergistic effect of their different modes of action and curtail individual drug doses, thereby minimizing their side effects, Opioid-free anesthesia (OFA) Sympathetic and parasympathetic suppression can be achieved today with loco-regional anaesthesia or by several non-opioid drugs. Opioid free general anaesthesia can be achieved with 50 mg ketamine given after propofol and before incision in spontaneous breathing patients like for plastic surgery .The alpha-2agonists , suppress better the sympathetic system and can replace opioids for sympathetic stabilization in major surgery

Registry
clinicaltrials.gov
Start Date
January 31, 2024
End Date
July 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Asmaa Gomaa

principle investigator

Al-Azhar University

Eligibility Criteria

Inclusion Criteria

  • scheduled for laparoscopic cholecystectomy
  • american society of anaesthesiologists' physical status ǀ and ǁ
  • body mass index less than 30

Exclusion Criteria

  • Patients with uncontrolled hypertension and Diabetes mellitus.
  • Patient's currently taking opioid for chronic pain.
  • Patients with allergies to study medication.
  • Patients with cardiorespiratory disorder.
  • Patients with hepatic and renal insufficiency

Outcomes

Primary Outcomes

Visual analogue score

Time Frame: first postoperative day after surgery

assessment of postopeative pain after laparoscopic cholecystectomy Score ranging from 0 to 10. 0 = the best , 10= the worst

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