Hemodynamics Stability During Opioid Free Anesthesia for Patients with Obesity

Not Applicable

Completed

• Conditions: Obesity; General Anesthesia; Opioid Free Anaesthesia
• Interventions: Drug: Opioid Free Anaesthesia; Drug: Opioid based Anesthesia

• Registration Number: NCT06714981
• Lead Sponsor: Medical University of Lodz

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.

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.

Study Timeline

• Study Start: 2022-01-02
• Primary Completion: 2023-01-02
• Study Completion: 2023-06-02
• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• lack of consent
• emergency operation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
opioid free anesthesia	Opioid Free Anaesthesia	patients received opioid free anesthesia
opioid based anesthesia	Opioid based Anesthesia	patients received opioid based anesthesia

Primary Outcome Measures

Name	Time	Method
hemodynamic stability, cardiac output	before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)	Hemodynamic parameters (esCCO - cardiac output l/min) were measured using Visimo monitor.
hemodynamic stability esCCI - cardiac index	before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)	Cardiac index esCCI - l/m2 was measured using Visimo monitor.
hemodynamic stability esSVI	before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)	Stroke voulme esSVI - l were measured using Visimo monitor.
hemodynamic stability: arterial pressure NIPC-SYS, NIPC-MEAN, NIPC-DIA	before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)	Arterial pressure NIPC-SYS, NIPC-MEAN, NIPC-DIA (mmHg) were measured using Visimo monitor.
hemodynamic stability HR - heart rate	before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)	HR were measured using Visimo monitor.

Trial Locations

Locations (1)

Medical University of Lodz; 🇵🇱 Lodz, Poland