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AzTrials

ObesityNCT06714981

Hemodynamics Stability During Opioid Free Anesthesia for Patients with Obesity

A study testing Opioid Free Anaesthesia and Opioid based Anesthesia in people with Obesity and General Anesthesia, run by Medical University of Lodz at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study evaluated the impact of Opioid-Free Anesthesia (OFA) and Fentanyl Anesthesia (FNT) on the hemodynamics of the circulatory system (HR, esCCO, esCCI, esSVI, BP: SYS, DIA, MEAN) in obese patients with a BMI > 40 undregoing laparoscopic bariatric surgery. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Opioid Free Anaesthesia and Opioid based Anesthesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePoland
Study dates
2 Jan 2022to 2 Jun 2023
Phase
Interventional
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • obese patients with a BMI > 40 kg/m2 undergoing elective laparoscopic bariatric surgery

Who cannot join

  • lack of consent
  • emergency operation

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Medical University of Lodz

    Lodz, 90-153

Other trials in Poland

About this study

Official title: A Comparison of Opioid-Free Anesthesia (OFA) and Standard Fentanyl-based General Anesthesia in Patients with Morbid Obesity Undergoing Laparoscopic Bariatric Surgery

The study evaluated the impact of Opioid-Free Anesthesia (OFA) and Fentanyl Anesthesia (FNT) on the hemodynamics of the circulatory system (HR, esCCO, esCCI, esSVI, BP: SYS, DIA, MEAN) in obese patients with a BMI > 40 undregoing laparoscopic bariatric surgery. Patients in the OFA group were anesthetized as follows: before induction: ketamine 0.15 mg/kg (corrected body weight), lidocaine 1-1.5 mg/kg (corrected body weight) slow infusion, magnesium sulfate 30-50 mg/kg (corrected body weight), dexamethasone 8 mg, paracetamol 2.0g. Maintenance: continuous infusion of ketamine 0.125-0.25 mg/kg/h (corrected body weight), lidocaine 1.5-3 mg/kg/h (corrected body weight), magnesium sulfate 10 mg/kg/min (corrected body weight), and rocuronium bromide 1.25 µg/kg/min (corrected body weight) were used. Patients in the FNT group were anesthetized as follows: before induction: fentanyl 1.5-3 µg/kg (corrected body weight) iv, preoxygenation with 100% oxygen for 3 minutes, propofol 2.5 mg/kg (actual body weight) and following confirmation of mask ventilation, rocuronium bromide 0.6 mg/kg (actual body weight) bolus. After achieving full neuromuscular blockade, the patient was intubated and connected to the anesthesia machine and ventilated with 1-1.5 MAC desflurane.

Read the detailed description

Adult patients (over 18 years old) with a BMI ≥ 40, ASA ≤ II, qualified for elective bariatric surgery under general anesthesia with endotracheal intubation, who provided informed, voluntary consent to participate in the study, were included. Patients with BMI < 40, ASA III and above, heart failure, arrhythmias (especially bradyarrhythmia), hypovolemia, shock, unstable coronary artery disease, autonomic neuropathy with orthostatic hypotension, with a history of allergic reactions, pregnancy, indications for urgent surgical intervention, or those who did not consent to participate in the study, were excluded. Patients' weight, height, and BMI were measured. All obtained data were anonymized.

After transporting the patient to the operating room, the envelope was opened, and the patient was assigned to either the OFA or FNT anesthesia group.

Patients in the OFA group were anesthetized as follows: before induction: ketamine 0.15 mg/kg (corrected body weight), lidocaine 1-1.5 mg/kg (corrected body weight) slow infusion, magnesium sulfate 30-50 mg/kg (corrected body weight), dexamethasone 8 mg, paracetamol 2.0g. Induction: after three minutes of preoxygenation with 100% oxygen, propofol 2.5 mg/kg (actual body weight) was administered. Following confirmation of mask ventilation, rocuronium bromide 0.6 mg/kg (actual body weight) was given. Bag-mask ventilation with 100% oxygen continued for 3 minutes. After achieving full neuromuscular blockade, confirmed by the loss of all four responses using a peripheral nerve stimulator, the patient was intubated and connected to the anesthesia machine and ventilated with 1-1.5 MAC sevoflurane. Maintenance: ketamine 0.125-0.25 mg/kg/h (corrected body weight), lidocaine 1.5-3 mg/kg/h (corrected body weight), magnesium sulfate 10 mg/kg/min (corrected body weight), and rocuronium bromide 1.25 µg/kg/min (corrected body weight) were used. After surgery, neuromuscular blockade was reversed with sugammadex at 2-4 mg/kg (corrected body weight). The patients were also administered ephedrine in case of hypotension, atropine for bradycardia, and beta-blockers for tachycardia and hypertension.

Patients in the FNT group were anesthetized as follows: before induction: fentanyl 1.5-3 µg/kg (corrected body weight) iv, preoxygenation with 100% oxygen for 3 minutes, propofol 2.5 mg/kg (actual body weight) and following confirmation of mask ventilation, rocuronium bromide 0.6 mg/kg (actual body weight) bolus. Bag-mask ventilation with 100% oxygen and 2% inhaled sevoflurane continued for 3 minutes. After achieving full neuromuscular blockade, the patient was intubated and connected to the anesthesia machine and ventilated with 1-1.5 MAC desflurane. Maintenance dose for fentanyl was 0.003-0.006 µg/kg/min (corrected body weight) and rocuronium bromide 1.25 µg/kg/min (corrected body weight) were used. After surgery, neuromuscular blockade was reversed with sugammadex at 2-4 mg/kg (corrected body weight).

During induction, patients were positioned supine with the head and torso elevated at a 25-degree angle on a positioning pad. Anesthetic monitoring included HR, NIPC-SYS, NIPC-MEAN, NIPC-DIA, SpO2, esCCO, esCCI, and esSVI using the Vismo monitor and EtCO2.

Hemodynamic parameters (esCCO, esCCI, esSVI, NIPC-SYS, NIPC-MEAN, NIPC-DIA, HR) were measured before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10).

The objective of the study is to compare the impact of OFA on hemodynamic parameters measured by non-invasive technique: esCCO, esCCI, esSVI, NIPC-SYS, NIPC-MEAN, NIPC-DIA, HR, in obese patients with BMI > 40, with those obtained during the commonly used FNT anesthesia.

Being tested
Opioid Free Anaesthesia, Opioid based Anesthesia
Keywords
general anesthesia, Opioid-Free Anesthesia, obesity, fentanyl, hemodynamics
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opioid Free AnaesthesiaDrug

    patients received opioid free anesthesia

  • Opioid based AnesthesiaDrug

    patients received opioid based anesthesia

Study groups in NCT06714981
Study groupRoleWhat they receive
opioid free anesthesiaExperimentalpatients received opioid free anesthesia
Receives: Drug: Opioid Free Anaesthesia
opioid based anesthesiaActive comparatorpatients received opioid based anesthesia
Receives: Drug: Opioid based Anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hemodynamic stability, cardiac output

    Hemodynamic parameters (esCCO - cardiac output l/min) were measured using Visimo monitor.

    Measured: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)

  2. hemodynamic stability esCCI - cardiac index

    Cardiac index esCCI - l/m2 was measured using Visimo monitor.

    Measured: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)

  3. hemodynamic stability esSVI

    Stroke voulme esSVI - l were measured using Visimo monitor.

    Measured: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)

  4. hemodynamic stability: arterial pressure NIPC-SYS, NIPC-MEAN, NIPC-DIA

    Arterial pressure NIPC-SYS, NIPC-MEAN, NIPC-DIA (mmHg) were measured using Visimo monitor.

    Measured: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)

  5. hemodynamic stability HR - heart rate

    HR were measured using Visimo monitor.

    Measured: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2024
  2. Study start2 Jan 2022
  3. Primary completion2 Jan 2023
  4. Study completion2 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06714981
Sponsor's protocol ID
RNN/60/16/KE
Status last verified
Nov 2024
First submitted
25 Nov 2024
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Opioid Free Anaesthesia and Opioid based Anesthesia in people with Obesity and General Anesthesia, run by Medical University of Lodz at 1 site in Poland.

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 1 inclusion and 2 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 4 Dec 2024. 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 Poland. 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?

hemodynamic stability, cardiac output (time frame: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)). 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?
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 4 Dec 2024.

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