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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Remifentanilio Titravimo būdų Palyginimas, Remiantis pacientų Budimo Kokybe Ligotai Nutukusiems Pacientams po laparoskopinių skrandžio tūrio mažinimo operacijų

Conditions
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Morbid Obesity

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 57 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Manual infusion (control) group<br> | |
| TCI (case) group<br> | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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morbid obesity, remifentanil, manual infusion, target - controlled infusion