Opioid-free anesthesia compared to standard anesthesia for bariatric surgery: clinical trial

Phase 2

Recruiting

• Conditions: Morbid Obesity; C18.654.726.500

• Registration Number: RBR-10tk7c76
• Lead Sponsor: Complexo Hospitalar Santa Genoveva

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-01
• Study Completion: 2023-02-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients included in the study protocol must meet the following prerequisites: age between 18 and 65 years; with a Body Mass Index (BMI) higher than 40 kg/m2 regardless of the presence of comorbidities or a BMI between 35 and 39.9 kg/ m2 in the presence of comorbidities; classified in the physical status ASA (American Society of Anaesthesiologists) of II or III; patients undergoing laparoscopic gastroplasty surgery under general anesthesia; expected hospital stay of up to 36 hours.

Exclusion Criteria

Patients who refuse to participate in the proposed study; patients who are younger than 18 and older than 65 years; who have a BMI (body mass index) lower than 35 kg/m2 or a BMI between 35 and 40 kg/m2 without comorbidities; patients who report adverse reactions to any drug included in the study; patients who have a history of alcohol or illicit substance abuse or chronic use of opioids for various reasons; patients who report liver or kidney failure; patients who have coexisting diseases that impair cognitive ability, such as poorly controlled psychiatric illnesses or neuropsychomotor developmental delay.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is the assessment of the incidence of composite opioid-related adverse effects in the first hours after extubation and during hospitalization. The components of the composition will be nausea and vomiting, hypoxemia, defined as Sp02 below 90% with need for supplemental oxygen, and sedation, defined as a score greater or equal to 2 on the Wilson scale.

Secondary Outcome Measures

Name	Time	Method
Bradycardia incidence (Heart rate less than 40 bpm);Arterial Hypotension (Mean arterial pressure less than 60 mmHg);Postoperative nausea and vomiting incidence (PONV);Postanestia care unit lenght of stay ;Hypoxemia incidence (SatO2 less than 90%);Pain burden;Pain intensity through verbal numeric rating scale (NRS);Rescue opioid consumption;Patient satisfaction through numeric verbal scale;Quality of Recovery using QoR-15 questionnaire