Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06650371

Opioid Free Anesthesia Versus Opioid Based Anesthesia

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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Fentanyl infusion

Drug

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

Dexamedomedine and ketamine infusion

Drug

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

Primary outcomes

  1. Time between the end of analgesic used and an Aldrete score > 9 (when applicable).

    Time frame: 15 minutes

    Decrease opioid usage ,decrease recovery time

  2. Time between the end of operation to PACU

    Time frame: 15 minutes

    Decrease opioid usage ,decrease recovery time

Secondary outcomes

  1. Cumulative pethidine consumption

    Time frame: 24 hours postoperative

    decrease the need to postoperative pethidine

  2. Number of episodes of nausea and vomiting [Time Frame: During the 24 hours following extubation].

    Time frame: 24 hours postoperative

    number of episodes of nausea and vomiting postoperative

Study contacts

Contact information is provided by the study sponsor or research team.

Eman Mohamed Zain

CONTACT

[email protected]

01017254024

Eman Zain

CONTACT

01017254024

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 21, 2024
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.