- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06231992
Opioid Free Anaesthesia Versus Opioid Based Anesthesia for Laparscopic Cholecystectomy
January 21, 2024 updated by: Asmaa Gomaa, Al-Azhar University
Comparative Study Between Opioid Free Anaesthesia Versus Opioid Based Anesthesia for Laparscopic Cholecystectomy
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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
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:
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
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: opioid based anesthesia
I.V Fentanyl (1-2ug/kg) before induction of general anesthesia with I.V propofol (1-2mg/kg), atracurium (0.5mg/kg).
Intermittent boluses of fentanyl will be given intraoperatively when needed to maintain the change in hemodynamics within 20 % of the baseline.
|
I.V Fentanyl (1-2ug/kg) before induction of general anesthesia with I.V propofol (1-2mg/kg), atracurium (0.5mg/kg).
Intermittent boluses of fentanyl will be given intraoperatively when needed to maintain the change in hemodynamics within 20 % of the baseline.
|
Active Comparator: opioid free anesthesia
- IV Ketamine (0.25-0.5 mg/kg) before induction of general anesthesia with I.V propofol (1-2 mg/kg), atracurium (0.5mg/kg) followed by(0.25mg
/min) infusion of ketamine for maintenance.
Dexamethasone I.V (8 mg) will be given before induction of general anesthesia.
magnesium sulphate (20 mg/kg)in 100ml saline within 10 mints Followed by infusion of magnesium sulphate at rate of (10mg/kg/h).
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
first postoperative day after surgery
|
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 (Estimated)
January 31, 2024
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
December 27, 2023
First Submitted That Met QC Criteria
January 21, 2024
First Posted (Actual)
January 30, 2024
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 21, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Anesthesia for cholecystectomy
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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