Clinical trial NCT04260659: Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy
Official title: Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy: Clinical, Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Postoperative Pain
Postoperative Nausea
Postoperative Vomiting
Opioid Use
Keywords: Opioid free anesthesia
Laparoscopic sleeve gastrectomy
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Total postoperative oxycodone consumption
timeFrame: Day "0"
measure: Postoperative pain score in NRS scale
timeFrame: Day "0", assessed 1 hour after operation
measure: Postoperative pain score in NRS scale
timeFrame: Day "0", assessed 6 hours after operation
measure: Postoperative pain score in NRS scale
timeFrame: Day "0", assessed 12 hours after operation
measure: Postoperative pain score in NRS scale
timeFrame: Day "1" assessed 24 hours after operation
Secondary outcomes:
measure: Postoperative sedation score
timeFrame: Day "0", assessed 1,6,12 and 24 hours after operation
measure: Postoperative nausea and vomiting
timeFrame: Day "0", assessed 1,6,12 and 24 hours after operation
measure: Rescue fentanyl administration dosis
timeFrame: intraoperative
measure: Highest BP
timeFrame: intraoperative
measure: Lowest BP
timeFrame: intraoperative
measure: Highest HR
timeFrame: intraoperative
measure: Lowest HR
timeFrame: intraoperative
measure: Total ephedrine dosis
timeFrame: intraoperative
measure: Postoperative desaturation
timeFrame: Day "0", assessed 1,6,12 and 24 hours after operation
measure: Patient's comfort assessed in QoR-40 formulary
timeFrame: 7 days postoperatively
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Szpital Kliniczny Dzieciatka Jezus
Study officials:
affiliation: Medical University of Warsaw
name: Piotr Mieszczański, MD
role: PRINCIPAL_INVESTIGATOR
References: