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Completed

NCT Number: NCT04690088

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

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.

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Key information

Age range

28 year–57 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lithuanian University of Health Sciences

Kaunas, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. eye opening

    Time frame: up to 20 minutes

    The time of patient's respond after the end of remifentanyl infusion

  2. spontaneous breathing

    Time frame: up to 20 minutes

    The time of patient's respond after the end of remifentanyl infusion

  3. airway reflexes

    Time frame: up to 20 minutes

    The time of patient's respond after the end of remifentanyl infusion

  4. orientation

    Time frame: up to 20 minutes

    The time of patient's respond after the end of remifentanyl infusion

  5. oral command

    Time frame: 2,4,6,8,10,12,14,16,18,20 minutes

    The time of patient's respond after the end of remifentanyl infusion

Secondary outcomes

  1. Heart rate

    Time frame: up to 20 minutes

    Measure was started after the end of remifentanyl infusion

  2. Arterial blood pressure

    Time frame: up to 20 minutes

    Measure was started after the end of remifentanyl infusion

  3. Saturation

    Time frame: up to 20 minutes

    Measure was started to record after the end of remifentanyl infusion

  4. Remifentanyl dose

    Time frame: up to 20 minutes after surgery

    The amount of medication used during surgery

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Dec 30, 2020
Registry last updated
Dec 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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