Clinical trial

Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy: Clinical, Randomised Study

Name

OFA LSG

Description

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.

Trial arms

Trial start

2020-02-04

Estimated PCD

2022-10-06

Trial end

2023-02-22

Status

Completed

Phase

Early phase I

Treatment

Dexmedetomidine Hydrochloride [Dexdor]

Initial dosis of dexmedetomidine 1 mcg/kg IBW iv will be administered within 10 minutes before general anesthesia induction. Following intubation infusion of 1 mcg/kg IBW / h will be initiated and continued until the end of operation.

Arms:

Opioid free group

Remifentanil [Ultiva]

Remifentanil TCI Minto Model will be used during induction in dosis 6 ng/ml and intraoperatively appropriately to maintain hemodynamical stability.

Arms:

Opioid liberal group

Ketamine [Ketalar]

Ketamine 0,5mg/kg IBW iv will be administered during induction of general anesthesia.

Arms:

Opioid free group

Lidocaine [Xylocaine 2%]

Initial dosis of lidocaine 1,5 mg/kg IBW iv will be administered within 10 minutes before general anesthesia induction. Following intubation infusion of 3 mg/kg IBW / h will be initiated and continued until the end of operation.

Arms:

Opioid free group

Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]

Magnesium Sulphate will be administered in dosis 50 mg/kg IBW iv intraoperatively.

Arms:

Opioid free group

Fentanyl [Fentanyl WZF]

Rescue dosis of 100 mcg iv will be administered if hypertension \> 140/90 mmHg or tachycardia \> 120min occurs. If necessary rescue dosis may be repeated.

Arms:

Opioid free group

Size

Primary endpoint

Total postoperative oxycodone consumption

Day "0"

Postoperative pain score in NRS scale

Day "0", assessed 1 hour after operation

Postoperative pain score in NRS scale

Day "0", assessed 6 hours after operation

Postoperative pain score in NRS scale

Day "0", assessed 12 hours after operation

Postoperative pain score in NRS scale

Day "1" assessed 24 hours after operation

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 59, 'type': 'ACTUAL'}}

Updated at

2023-03-08

1 organization

6 products

5 indications

Organization

Medical University of Warsaw

Product

Dexmedetomidine Hydrochloride

Indication

Obesity

Indication