Opioid Free Anesthesia Versus Opioid Based Anesthesia

Ain Shams University

Status: Not yet enrolling

Conditions: Laparoscopic Bariatric Surgeries; Opioid Free Anesthesia

Treatments: Drug: Dexamedomedine and ketamine infusion; Drug: Fentanyl infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06650371

FMASU MD126/2024

Details and patient eligibility

About

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).

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Fentanyl infusion

Active Comparator group

Description:

Analgesia will be offered by fentanyl in induction and maintenance according to ideal body weight (IBW).

Treatment:

Drug: Fentanyl infusion

Dexamedomedine and ketamine infusion

Active Comparator group

Description:

Opioid free anesthesia Analgesia will be offered by syringe containing ketamine and dexmedetomidine in induction and maintenance according to IBW.

Treatment:

Drug: Dexamedomedine and ketamine infusion