NCT06714981

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 25, 2024

Last Update Submit

December 3, 2024

Conditions

ObesityGeneral AnesthesiaOpioid Free Anaesthesia

Keywords

general anesthesiaOpioid-Free Anesthesiaobesityfentanylhemodynamics

Outcome Measures

Primary Outcomes (5)

  • hemodynamic stability, cardiac output

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

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

  • hemodynamic stability esCCI - cardiac index

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

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

  • hemodynamic stability esSVI

    Stroke voulme esSVI - l were measured using Visimo monitor.

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

  • hemodynamic stability: arterial pressure NIPC-SYS, NIPC-MEAN, NIPC-DIA

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

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

  • hemodynamic stability HR - heart rate

    HR were measured using Visimo monitor.

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

Study Arms (2)

opioid free anesthesia

EXPERIMENTAL

patients received opioid free anesthesia

Drug: Opioid Free Anaesthesia

opioid based anesthesia

ACTIVE COMPARATOR

patients received opioid based anesthesia

Drug: Opioid based Anesthesia

Interventions

Opioid Free AnaesthesiaDRUG

patients received opioid free anesthesia

opioid free anesthesia
Opioid based AnesthesiaDRUG

patients received opioid based anesthesia

opioid based anesthesia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • lack of consent
  • emergency operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Lodz

Lodz, 90-153, Poland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of anesthesia

Study Record Dates

First Submitted

November 25, 2024

First Posted

December 4, 2024

Study Start

January 2, 2022

Primary Completion

January 2, 2023

Study Completion

June 2, 2023

Last Updated

December 4, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)