Clinical trial NCT06650371: Opioid Free Anesthesia Versus Opioid Based Anesthesia
Official title: Comparative Study Between the Performance of Opioid Free Anesthesia Versus Conventional Opioid Based Anesthesia Regarding Achievement of Enhanced Recovery in Laparoscopic Bariatric Surgeries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Free Anesthesia
Laparoscopic Bariatric Surgeries
Keywords: Opioid free anesthesia
laparoscopic bariatric surgeries
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 36
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: This Study aims to evaluate the efficacy of opioid free general anesthesia in achieving enhanced recovery after surgery (ERAS) in laparoscopic bariatric surgery in terms of post-operative recovery time, cumulative pethidine consumption and number of episodes of postoperative nausea and vomiting(PONV).

Detailed description: While opioids have been commonly used in the operating room due to their effectiveness in pain management and anesthesia, there are numerous common side effects that have an impact on patient recovery. Obese patients or those with pre-existing respiratory difficulties such as sleep apnea or chronic obstructive pulmonary disease are more likely to experience respiratory failure after getting opiate therapy. Other effects of opioid use include gastro-intestinal obstacles such nausea, vomiting, and constipation.

The concept of opioid-free anesthesia evolved due to the potential adverse side effects associated with intraoperative opioid usage.

This study examines nociceptive monitoring's potential role in opioid-free anesthesia, as well as research on the topic. This study aims to compare the effects of an opioid-free anesthesia (OFA) regimen versus an opioid-based anesthesia (OBA) regimen on postoperative pain and enhanced recovery in patients undergoing bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* Undergoing a scheduled laparoscopic bariatric surgery under general anesthesia.
* Age group: 18-65 years old.
* BMI greater than 35 to 50 Kg/m2
* ASA physical status classes I and II.

Exclusion Criteria:

* Patient refusal.
* ASA physical status classes III and IV.
* Anticipated difficult intubation.
* Hypersensitivity to any drugs used in this study. Inability to extubate the patient at the end of the operation. Conversion to laparotomy. Patients for whom the anesthetic regimen is changed intraoperatively (from OFA to OBA or vice versa).

Primary outcomes:
measure: Time between the end of analgesic used and an Aldrete score &gt; 9 (when applicable).
timeFrame: 15 minutes
measure: Time between the end of operation to PACU
timeFrame: 15 minutes
Secondary outcomes:
measure: Cumulative pethidine consumption
timeFrame: 24 hours postoperative
measure: Number of episodes of nausea and vomiting [Time Frame: During the 24 hours following extubation].
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
Study officials:
References: