Remifentanil Dosing Regimes for Anesthesia in Bariatric Surgery: Characteristics of Early Recovery

Completed

• Conditions: Morbid Obesity

• Registration Number: NCT04690088
• Lead Sponsor: Lithuanian University of Health Sciences

Brief Summary

Early recovery characteristics are important for patients' safety and operating room turnover. Our aim was to compare fundamental methods for dosing remifentanil during morbid obesity surgeries: a manual infusion and a target-controlled infusion (TCI). Throughout study, patient's recovery time was tracked and compared between the groups.

Detailed Description

Introduction: The population of overweighted patients is increasing dramatically, therefore physicians face them in their daily practice (1-2). There are many guidelines showing the dose counting methods of intravenous anesthetics, but none of them are perfectly good for morbidity obese patients (3). Early recovery characteristics are important for patients' safety and operating room turnover (4).

Aim: Our aim was to compare fundamental methods for dosing remifentanil during morbid obesity surgeries: a manual infusion and a target-controlled infusion (TCI). Throughout study, patient's recovery time was tracked and compared between the groups.

Methods: 31 patients were evaluated who underwent bariatric surgery in Hospital of Lithuanian University of Health Sciences. All of them had received sevoflurane/remifentanil anaesthesia. Remifentanil infusion was randomly assigned to a manual (control group) or to a TCI (case group) method. We had evaluated patients' hemodynamics (arterial blood pressure, heart rate, saturation), spontaneous breathing and airway reflexes recovery time, time of extubation, eye opening, recovery of orientation and start of the following oral command. Also we had registered concentrations of remifentanil in the blood (according to automatic infusion pump) while using TCI method.

Study Timeline

• Study Start: 2019-10-10
• Primary Completion: 2019-12-01
• Study Completion: 2020-02-10
• Study First Submitted: 2020-10-08
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-28
• Last Update Submitted: 2020-12-28
• Study First Posted: 2020-12-30
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Morbid patients to whom, according guidelines (BMI > 45 or BMI > 35 and chronic disease) bariatric surgery is indicated.
• Patient's approval.

Exclusion Criteria

• Patients, younger than 18 years old.
• Patients who are higher than III ASA class.
• Patients who have higher sensibility to medications that are used during anesthesia.
• Patients with phycological disorders.
• Patients who can not fully communicate because of language barriers.
• Patients with surgical complications.
• Patient's disapproval.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eye opening	up to 20 minutes	The time of patient's respond after the end of remifentanyl infusion
spontaneous breathing	up to 20 minutes	The time of patient's respond after the end of remifentanyl infusion
airway reflexes	up to 20 minutes	The time of patient's respond after the end of remifentanyl infusion
orientation	up to 20 minutes	The time of patient's respond after the end of remifentanyl infusion
oral command	2,4,6,8,10,12,14,16,18,20 minutes	The time of patient's respond after the end of remifentanyl infusion

Secondary Outcome Measures

Name	Time	Method
Heart rate	up to 20 minutes	Measure was started after the end of remifentanyl infusion
Arterial blood pressure	up to 20 minutes	Measure was started after the end of remifentanyl infusion
Saturation	up to 20 minutes	Measure was started to record after the end of remifentanyl infusion
Remifentanyl dose	up to 20 minutes after surgery	The amount of medication used during surgery

Trial Locations

Locations (1)

Lithuanian University of Health Sciences; 🇱🇹 Kaunas, Lithuania