Clinical trial NCT06714981: Hemodynamics Stability During Opioid Free Anesthesia for Patients with Obesity
Official title: A Comparison of Opioid-Free Anesthesia (OFA) and Standard Fentanyl-based General Anesthesia in Patients with Morbid Obesity Undergoing Laparoscopic Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
General Anesthesia
Opioid Free Anaesthesia
Keywords: general anesthesia
Opioid-Free Anesthesia
obesity
fentanyl
hemodynamics
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* lack of consent
* emergency operation

Primary outcomes:
measure: hemodynamic stability, cardiac output
timeFrame: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
measure: hemodynamic stability esCCI - cardiac index
timeFrame: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
measure: hemodynamic stability esSVI
timeFrame: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
measure: hemodynamic stability: arterial pressure NIPC-SYS, NIPC-MEAN, NIPC-DIA
timeFrame: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
measure: hemodynamic stability HR - heart rate
timeFrame: before induction (T0) and then at 10-minute intervals after intubation and connection to the anesthesia machine (from T1 to T10)
Secondary outcomes:
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Medical University of Lodz
Study officials:
References: