Comparison of Total Intravenous Anesthesia and Inhalational Anesthesia in Opioid-Free Anesthesia for Bariatric Surgery: A Randomized Controlled Trial

NCT06390046 | Completed DMC

• 1 other identifier: 1072.6120.135.2023
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

Total intravenous general anesthesia and combined general anesthesia are recognized methods used during anesthesia. They allow you to effectively control pain and reduce the number of complications associated with taking large doses of opioid drugs. It should be emphasized that both methods of anesthesia are currently approved for use in routine anesthetic practice, and only the experience, knowledge and preferences of the anesthesiologist determine which technique will be used in a given patient. Both techniques are used in everyday anesthetic practice, but there is no conclusive scientific data confirming the superiority of either method in patients undergoing bariatric surgery, therefore currently only the individual experience, knowledge and preferences of the anesthesiologist determines which technique will be used in a given patient.

Conditions

Analgesics, Opioid; Anesthesia; Adverse Effect

Outcome Measures

Primary Outcomes (1)

• presence of PONV in postoperative period

  The incidence of postoperative nausea and vomiting (PONV) within the first 24 hours after surgery

  1 day

Secondary Outcomes (2)

• Postoperative recovery parameters

  1 day

• Opioid consumption

  1 day

Study Arms (2)

TIVA

ACTIVE COMPARATOR

total intravenously anesthetized (infusion of Propofol, Ketamine, Lignocaine and Dexmedetomidine)

Drug: TIVA versus Inhalation

Inhalation agent

EXPERIMENTAL

combined general anesthesia (infusion of Ketamine, Lignocaine and Dexmedetomidine and inhalation of Sevoflurane)

Drug: TIVA versus Inhalation

Interventions

TIVA versus Inhalation DRUG

comparing TIVA with genera anesthesia with inhalation agent

Inhalation agent; TIVA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years who underwent laparoscopic bariatric surgery

You may not qualify if:

• Patients with a history of allergic reactions to drugs Patients with a history of drug addiction Patients with chronic pain who require analgesics History of hospitalization for psychiatric disorders Preoperative pulse oximetry (SpO2) \< 95 % bradycardia (HR\<50bpm), hypotension, atrioventricular block, intraventricular or sinus block Blood clotting disorders Pregnant/lactating women Cognitive impairment Unable to read consent

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University

Krakow, Lesser Poland Voivodeship, 31501, Poland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD MD

Model Details: The study group will be male and female patients, ASA II or III, over 18 years of age and under 75 years of age. Each patient will undergo abdominal (bariatric) surgery.

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 29, 2024
• Study Start: April 30, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 5, 2026

Record last verified: 2024-04

Locations

PL (1)