Opioid Free Anesthesia Versus Opioid Based Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fentanyl infusion, Dexamedomedine and ketamine infusion.
- Who it may be relevant to
- Registry conditions: Opioid Free Anesthesia, Laparoscopic Bariatric Surgeries. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Study Between the Performance of Opioid Free Anesthesia Versus Conventional Opioid Based Anesthesia Regarding Achievement of Enhanced Recovery in Laparoscopic Bariatric Surgeries
Overview
This Study aims to evaluate the efficacy of opioid free general anesthesia in achieving enhanced recovery after surgery (ERAS) in laparoscopic bariatric surgery in terms of post-operative recovery time, cumulative pethidine consumption and number of episodes of postoperative nausea and vomiting(PONV).
Detailed description
While opioids have been commonly used in the operating room due to their effectiveness in pain management and anesthesia, there are numerous common side effects that have an impact on patient recovery. Obese patients or those with pre-existing respiratory difficulties such as sleep apnea or chronic obstructive pulmonary disease are more likely to experience respiratory failure after getting opiate therapy. Other effects of opioid use include gastro-intestinal obstacles such nausea, vomiting, and constipation.
The concept of opioid-free anesthesia evolved due to the potential adverse side effects associated with intraoperative opioid usage.
This study examines nociceptive monitoring's potential role in opioid-free anesthesia, as well as research on the topic. This study aims to compare the effects of an opioid-free anesthesia (OFA) regimen versus an opioid-based anesthesia (OBA) regimen on postoperative pain and enhanced recovery in patients undergoing bariatric surgery.
Interventions
- Drug Fentanyl infusion
opioid based anesthesia analgesia will be offered by fentanyl in induction and maintenance according to Ideal Body Weight (IBW). - Drug Dexamedomedine and ketamine infusion
Analgesia will be offered by syringe containing ketamine and Dexmedetomidine in induction and maintenance according to IBW.
Primary outcome measures
- Time between the end of analgesic used and an Aldrete score > 9 (when applicable). [Time frame: 15 minutes]
- Time between the end of operation to PACU [Time frame: 15 minutes]
Secondary outcome measures (2)
- Cumulative pethidine consumption [Time frame: 24 hours postoperative]
- Number of episodes of nausea and vomiting [Time Frame: During the 24 hours following extubation]. [Time frame: 24 hours postoperative]
Eligibility criteria
Inclusion criteria
- Undergoing a scheduled laparoscopic bariatric surgery under general anesthesia.
- Age group: 18-65 years old.
- BMI greater than 35 to 50 Kg/m2
- ASA physical status classes I and II.
Exclusion criteria
- Patient refusal.
- ASA physical status classes III and IV.
- Anticipated difficult intubation.
- Hypersensitivity to any drugs used in this study. Inability to extubate the patient at the end of the operation. Conversion to laparotomy. Patients for whom the anesthetic regimen is changed intraoperatively (from OFA to OBA or vice versa).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06650371 · FMASU MD126/2024