Morbid ObesityNCT04690088
Remifentanil Dosing Regimes for Anesthesia in Bariatric Surgery: Characteristics of Early Recovery
An observational study of Morbid Obesity, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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). Read more about this study
- Who is it for?
- Ages 28 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- How many people
- 31 participants
- Where
- 1 siteLithuania
- Study dates
- 10 Oct 2019to 10 Feb 2020
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with morbid obesity who are hospitalised in Hospital of Lithuanian University of Health Sciences Kaunas Clinics for laparoscopic bariatric surgery.
Who may be able to join
- Morbid patients to whom, according guidelines (BMI > 45 or BMI > 35 and chronic disease) bariatric surgery is indicated.
- Patient's approval.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity, remifentanil, manual infusion, target - controlled infusion
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Manual infusion (control) group | Not described | |
| TCI (case) group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
eye opening
The time of patient's respond after the end of remifentanyl infusion
Measured: up to 20 minutes
spontaneous breathing
The time of patient's respond after the end of remifentanyl infusion
Measured: up to 20 minutes
airway reflexes
The time of patient's respond after the end of remifentanyl infusion
Measured: up to 20 minutes
orientation
The time of patient's respond after the end of remifentanyl infusion
Measured: up to 20 minutes
oral command
The time of patient's respond after the end of remifentanyl infusion
Measured: 2,4,6,8,10,12,14,16,18,20 minutes
Secondary outcomes (4)
Heart rate
Measure was started after the end of remifentanyl infusion
Measured: up to 20 minutes
Arterial blood pressure
Measure was started after the end of remifentanyl infusion
Measured: up to 20 minutes
Saturation
Measure was started to record after the end of remifentanyl infusion
Measured: up to 20 minutes
Remifentanyl dose
The amount of medication used during surgery
Measured: up to 20 minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start10 Oct 2019
- Primary completion1 Dec 2019
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulina Aldakauskaite, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690088
- Sponsor's protocol ID
- BEC - MF - 93
- Status last verified
- Dec 2020
- First submitted
- 8 Oct 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 9813653Cheymol G. Effects of obesity on pharmacokinetics implications for drug therapy. Clin Pharmacokinet. 2000 Sep;39(3):215-31. doi: 10.2165/00003088-200039030-00004.
PubMed 11020136Adams 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.
PubMed 10927998Michelsen 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.
PubMed 8982900Egan 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.
PubMed 14970134
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanilio Titravimo būdų Palyginimas, Remiantis pacientų Budimo Kokybe Ligotai Nutukusiems Pacientams po laparoskopinių skrandžio tūrio mažinimo operacijų
- ClinicalTrials.gov ID
- NCT04690088
- Acronym / sponsor ID
- BEC - MF - 93
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity, remifentanil, manual infusion, target - controlled infusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual infusion (control) group | – | – |
| TCI (case) group | – | – |
Who may qualify
- Ages
- 28 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with morbid obesity who are hospitalised in Hospital of Lithuanian University of Health Sciences Kaunas Clinics for laparoscopic bariatric surgery.
Key inclusion criteria (2 listed)
- Morbid patients to whom, according guidelines (BMI > 45 or BMI > 35 and chronic disease) bariatric surgery is indicated.
- Patient's approval.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
eye opening
Time frame: up to 20 minutes
The time of patient's respond after the end of remifentanyl infusion
spontaneous breathing
Time frame: up to 20 minutes
The time of patient's respond after the end of remifentanyl infusion
airway reflexes
Time frame: up to 20 minutes
The time of patient's respond after the end of remifentanyl infusion
orientation
Time frame: up to 20 minutes
The time of patient's respond after the end of remifentanyl infusion
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
4 secondary outcomes
Heart rate
Time frame: up to 20 minutes
Arterial blood pressure
Time frame: up to 20 minutes
Saturation
Time frame: up to 20 minutes
Remifentanyl dose
Time frame: up to 20 minutes after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Background: PubMed 9813653Clinical 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.
- Background: PubMed 11020136Cheymol G. Effects of obesity on pharmacokinetics implications for drug therapy. Clin Pharmacokinet. 2000 Sep;39(3):215-31. doi: 10.2165/00003088-200039030-00004.
- Background: PubMed 10927998Adams 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.
- Background: PubMed 8982900Michelsen 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.
- Background: PubMed 14970134Egan 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.
- Egan T D. Remyfentanil Pharmacocinetics and Pharmacodynamics. Clin. Pharmacokinet 1995; 29:80.Link provided by the sponsor.
- Valstybinė vaistų kontrolės tarnyba. Remifentanil Kabi.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eye opening (time frame: up to 20 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04690088, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.