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

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

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity

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 Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania
    • Lithuanian University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 57 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Manual infusion (control) group
TCI (case) group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences

Publications and helpful links

General Publications

• 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. Erratum In: Obes Res 1998 Nov;6(6):464.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Body - Mass index. Evaluation of BMI over time.
• Cortrnez L I, Anderson B J. Current Opinion in Anaesthesiology 2018; 31(4):415-422.
• Egan T D. Remyfentanil Pharmacocinetics and Pharmacodynamics. Clin. Pharmacokinet 1995; 29:80.
• Valstybinė vaistų kontrolės tarnyba. Remifentanil Kabi.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2019
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): February 10, 2020

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (ACTUAL): December 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: remifentanil; morbid obesity; manual infusion; target - controlled infusion
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: BEC - MF - 93

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No