Clinical trial NCT06736496: Comparative Study of Opioid-Free Anesthesia Versus Opioid Anesthesia in Patients Undergoing Laparoscopic Cholecystectomy
Official title: Comparative Study of Opioid-Free Anesthesia Versus Opioid Anesthesia in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Laparoscopic Cholecystectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopic cholecystectomy is an effective surgical approach for the treatment of gallbladder disorders such as cholecystitis, gallbladder stones or gallbladder polyps. Although the surgical technique for the treatment of cholecystitis with laparoscope shows some gains compared to open surgery, postoperative complications such as abdominal incision pain, nausea and vomiting, or other complications are still challenging issues.

Thus, there is a need to study and evaluate new non-opioid pain medications after laparoscopic cholecystectomy as part of an opioid reduction strategy.the aim of the study is To compare the effectiveness and safety of opioid-free anesthesia versus opioid-based anesthesia in patients undergoing laparoscopic cholecystectomy, focusing on pain management, postoperative recovery, and incidence of adverse effects.

Detailed description: Anesthesia requires a full spectrum of drugs, from which an anesthetic plan can be applied to achieve the desired level of sedation, analgesia, amnesia, muscle relaxation, and reflex abolition.

Opioid administration as a bolus dose or continuous infusion is commonly used by anesthesiologists in major and day care surgeries. Using of opioids during anesthesia is associated with various opioid-related adverse effects such as respiratory depression, opioid-induced hyperalgesia, nausea and vomiting, urinary retention, paralytic ileus, and the risk of cognitive and sleep dysfunction , This negative side effect profile of opioids may cause delayed recovery and discharge of patients from the post-anesthesia care unit as well as unanticipated hospital readmissions.

The emergence of opioid-free anesthesia was prompted by the adverse effects of opioids and the ongoing opioid epidemic.

Opioid-free anesthesia is a multimodal anesthetic and analgesic without the use of opioid drugs and can play a crucial role in enhanced recovery after surgery.

Eligibility criteria: Inclusion Criteria:

* o Adults aged 18-65 years.

  * Scheduled for elective laparoscopic cholecystectomy.
  * ASA Physical Status I-III.
  * Provided informed consent.

Exclusion Criteria:

* patients with a history of alcohol or drug abuse.

  * Chronic opioid use or dependence.
  * basal heart rate (HR) ≤ 50 beats/min.
  * Allergies to study medications.
  * Severe renal or hepatic impairment.
  * Pregnancy or lactation.

Primary outcomes:
measure: amount of opioid consumption
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Blaudszun G, Lysakowski C, Elia N, Tramer MR. Effect of perioperative systemic alpha2 agonists on postoperative morphine consumption and pain intensity: systematic review and meta-analysis of randomized controlled trials. Anesthesiology. 2012 Jun;116(6):1312-22. doi: 10.1097/ALN.0b013e31825681cb.
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