Opioid Free Anesthesia Versus Opioid Based Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-08-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Opioid Free Anesthesia Laparoscopic Bariatric Surgeries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Fentanyl infusion

Analgesia will be offered by fentanyl in induction and maintenance according to ideal body weight (IBW).

Group Type ACTIVE_COMPARATOR

Fentanyl infusion

Intervention Type DRUG

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

Dexamedomedine and ketamine infusion

Opioid free anesthesia Analgesia will be offered by syringe containing ketamine and dexmedetomidine in induction and maintenance according to IBW.

Group Type ACTIVE_COMPARATOR

Dexamedomedine and ketamine infusion

Intervention Type DRUG

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

Interventions

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Fentanyl infusion

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

Intervention Type DRUG

Dexamedomedine and ketamine infusion

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

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No