Opioid Free Anaesthesia Versus Opioid Based Anesthesia for Laparscopic Cholecystectomy

NCT ID: NCT06231992

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2024-07-31

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

Conditions

Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

opioid anaesthesia

Intervention Type: PROCEDURE

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.

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).

Group Type: ACTIVE_COMPARATOR

Opioid free anaesthesia

Intervention Type: PROCEDURE

• 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).

Interventions

opioid anaesthesia

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.

Intervention Type: PROCEDURE

Opioid free anaesthesia

• 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).

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Gomaa

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Anesthesia for cholecystectomy

Identifier Type: -

Identifier Source: org_study_id