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Opioid Free Anesthesia Versus Opioid Based Anesthesia

Comparative Study Between the Performance of Opioid Free Anesthesia Versus Conventional Opioid Based Anesthesia Regarding Achievement of Enhanced Recovery in Laparoscopic Bariatric Surgeries

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06650371
Enrollment
36
Registered
2024-10-21
Start date
2024-11-20
Completion date
2025-08-01
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Free Anesthesia, Laparoscopic Bariatric Surgeries

Keywords

Opioid free anesthesia, laparoscopic bariatric surgeries

Brief summary

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

opioid based anesthesia analgesia will be offered by fentanyl in induction and maintenance according to Ideal Body Weight (IBW).

DRUGDexamedomedine and ketamine infusion

Analgesia will be offered by syringe containing ketamine and Dexmedetomidine in induction and maintenance according to IBW.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Time between the end of analgesic used and an Aldrete score > 9 (when applicable).15 minutesDecrease opioid usage ,decrease recovery time
Time between the end of operation to PACU15 minutesDecrease opioid usage ,decrease recovery time

Secondary

MeasureTime frameDescription
Cumulative pethidine consumption24 hours postoperativedecrease the need to postoperative pethidine
Number of episodes of nausea and vomiting [Time Frame: During the 24 hours following extubation].24 hours postoperativenumber of episodes of nausea and vomiting postoperative

Contacts

Primary ContactEman Mohamed Zain
emanzain@med.asu.edu.eg01017254024
Backup ContactEman Zain
01017254024

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026