Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

Medical University of Warsaw

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Obesity; Opioid Use; Postoperative Vomiting; Postoperative Nausea

Treatments: Drug: Ketamine [Ketalar]; Drug: Remifentanil [Ultiva]; Drug: Lidocaine [Xylocaine 2%]; Drug: Fentanyl [Fentanyl WZF]; Drug: Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]; Drug: Dexmedetomidine Hydrochloride [Dexdor]

Study type: Interventional

Funder types: Other

Identifiers

NCT04260659

OFA LSG

Details and patient eligibility

About

Opioid free anesthesia is an anesthetic technique, in which administration of multimodal analgesia and sympathicolytics provides hemodynamic stability without use of opioids. Such management may be beneficial to the obese patients undergoing laparoscopic sleeve gastrectomy. Our study aims to compare opioid free anesthesia in such patients with standard, short-acting opioid based.

Full description

The study has been approved by Bioethical Committee of Medical University of Warsaw. Informed written consent will be obtained from all patients. Sample size of 60 patients has been calculated based on the Altman normogram to obtain 30% reduction of postoperative opioid consumption with significance and power of 90%.

Consenting patients scheduled for laparoscopic sleeve gastrectomy will be randomly assigned to the computer generated list to receive opioid free or standard opioid based anesthesia.

Opioid free protocol includes administration of dexmedetomidine, lidocaine, ketamine, magnesium sulphate whereas standard group will receive remifentanil TCI Minto Model.

After the end of operation all of the patient will receive oxycodone and additional doses via PCA system for postoperative analgesia.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sleeve gastrectomy in patients with BMI > 40 or >35 with comorbidities
• Written informed consent

Exclusion criteria

• Patient's refusal
• Known allergies to study medication
• Inability to comprehend or participate In pain scoring scale
• Inability to use intravenous patient controlled analgesia
• Changes of operation extent during procedure
• Revisional operations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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59 participants in 2 patient groups

Opioid liberal group

Active Comparator group

Treatment:

Drug: Remifentanil [Ultiva]

Opioid free group

Experimental group

Treatment:

Drug: Dexmedetomidine Hydrochloride [Dexdor]

Drug: Fentanyl [Fentanyl WZF]

Drug: Lidocaine [Xylocaine 2%]

Drug: Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]

Drug: Ketamine [Ketalar]