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Opioid Free Anesthesia Versus Opioid Based Anesthesia

ConditionsOpioid Free AnesthesiaLaparoscopic Bariatric Surgeries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAin Shams University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Fentanyl infusionActive comparator 1 intervention
Group B: Dexamedomedine and ketamine infusionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Decrease opioid usage ,decrease recovery time

Time frame
15 minutes
2

Time between the end of operation to PACU

Decrease opioid usage ,decrease recovery time

Time frame
15 minutes

Secondary outcomes

1

Cumulative pethidine consumption

decrease the need to postoperative pethidine

Time frame
24 hours postoperative
2

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

number of episodes of nausea and vomiting postoperative

Time frame
24 hours postoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: