Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy: Clinical, Randomised Study
Overview
- Phase
- Phase 4
- Intervention
- Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]
- Conditions
- Obesity
- Sponsor
- Medical University of Warsaw
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Postoperative pain score in NRS scale
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Arms & Interventions
Opioid free group
Intervention: Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]
Opioid liberal group
Intervention: Remifentanil [Ultiva]
Opioid free group
Intervention: Dexmedetomidine Hydrochloride [Dexdor]
Opioid free group
Intervention: Ketamine [Ketalar]
Opioid free group
Intervention: Lidocaine [Xylocaine 2%]
Opioid free group
Intervention: Fentanyl [Fentanyl WZF]
Outcomes
Primary Outcomes
Postoperative pain score in NRS scale
Time Frame: Day "1" assessed 24 hours after operation
NRS range from 0 for no pain to 10 for worst pain imaginable
Total postoperative oxycodone consumption
Time Frame: Day "0"
PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes
Secondary Outcomes
- Total ephedrine dosis(intraoperative)
- Postoperative desaturation(Day "0", assessed 1,6,12 and 24 hours after operation)
- Patient's comfort assessed in QoR-40 formulary(7 days postoperatively)
- Postoperative nausea and vomiting(Day "0", assessed 1,6,12 and 24 hours after operation)
- Rescue fentanyl administration dosis(intraoperative)
- Highest BP(intraoperative)
- Lowest BP(intraoperative)
- Highest HR(intraoperative)
- Lowest HR(intraoperative)
- Postoperative sedation score(Day "0", assessed 1,6,12 and 24 hours after operation)