Clinical trial NCT04690088: Remifentanil Dosing Regimes for Anesthesia in Bariatric Surgery: Characteristics of Early Recovery
Official title: Remifentanilio Titravimo būdų Palyginimas, Remiantis pacientų Budimo Kokybe Ligotai Nutukusiems Pacientams po laparoskopinių skrandžio tūrio mažinimo operacijų
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: morbid obesity
remifentanil
manual infusion
target - controlled infusion
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 31
Sex: ALL
Minimum age (years): 28
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with morbid obesity who are hospitalised in Hospital of Lithuanian University of Health Sciences Kaunas Clinics for laparoscopic bariatric surgery.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: eye opening
timeFrame: up to 20 minutes
measure: spontaneous breathing
timeFrame: up to 20 minutes
measure: airway reflexes
timeFrame: up to 20 minutes
measure: orientation
timeFrame: up to 20 minutes
measure: oral command
timeFrame: 2,4,6,8,10,12,14,16,18,20 minutes
Secondary outcomes:
measure: Heart rate
timeFrame: up to 20 minutes
measure: Arterial blood pressure
timeFrame: up to 20 minutes
measure: Saturation
timeFrame: up to 20 minutes
measure: Remifentanyl dose
timeFrame: up to 20 minutes after surgery
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
References:
citation: Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998 Sep;6 Suppl 2:51S-209S. No abstract available.
citation: Cheymol G. Effects of obesity on pharmacokinetics implications for drug therapy. Clin Pharmacokinet. 2000 Sep;39(3):215-31. doi: 10.2165/00003088-200039030-00004.
citation: Adams JP, Murphy PG. Obesity in anaesthesia and intensive care. Br J Anaesth. 2000 Jul;85(1):91-108. doi: 10.1093/bja/85.1.91. No abstract available.
citation: Michelsen LG, Hug CC Jr. The pharmacokinetics of remifentanil. J Clin Anesth. 1996 Dec;8(8):679-82. doi: 10.1016/s0952-8180(96)00179-1.
citation: Egan TD, Kern SE, Muir KT, White J. Remifentanil by bolus injection: a safety, pharmacokinetic, pharmacodynamic, and age effect investigation in human volunteers. Br J Anaesth. 2004 Mar;92(3):335-43. doi: 10.1093/bja/aeh075.