Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obesity
- Opioid Use
- Postoperative Nausea
- Postoperative Pain
- Postoperative Vomiting
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04260659
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Piotr Mieszcza?ski, MD Medical University of Warsaw
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