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

NCT ID: NCT06390046

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-14
• Study Completion Date: 2024-12-31

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.

Detailed Description

Patients undergoing bariatric surgery were randomly divided into two groups: one under complete intravenous anesthesia (infusion of Propofol, Ketamine, Lignocaine and Dexmedetomidine) and the other group under combined general anesthesia (infusion of Ketamine, Lignocaine and Dexmedetomidine and inhalation of Sevoflurane). In the postoperative period, all patients will receive Oxycodone NCA or in the form of oral tablets [naloxone (naloxone hydrochloride) + oxycodone (oxycodone hydrochloride)] and coanalgesics in the form of Paracetamol, Dexac, and Metamizol. Both methods of anesthesia are commonly used and used during bariatric and other surgical procedures. It should be emphasized once again that the above-mentioned all drugs are approved for routine use during anesthesia of patients, including obese patients, and our intervention only involves the use of a specific regimen from among those routinely available. The choice of anesthesia method depends on the anesthesiologist. During the study, we want to randomize patients into two groups: one will be anesthetized using a completely intravenous method, the other will be anesthetized using an inhalation anesthetic. In the postoperative period, patients will have their pain level assessed using the NRS scale 1, 2, 6, 12 and 24 hours after the procedure.

This study aimed to compare TIVA (propofol plus non-opioid adjuncts) with a sevoflurane-based anesthesia protocol, both incorporating OFA principles with lidocaine, ketamine, and dexmedetomidine infusions, in patients undergoing laparoscopic bariatric surgery. We hypothesized that both regimens would provide effective analgesia and recovery, with differences in recovery characteristics and postoperative nausea profiles. Moreover, we intended to evaluate whether a sevoflurane-based approach could match the clinical benefits of TIVA while aligning with current ecological and sustainability priorities in anesthesia.

Conditions

Analgesics, Opioid; Anesthesia; Adverse Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TIVA

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

Group Type: ACTIVE_COMPARATOR

TIVA versus Inhalation

Intervention Type: DRUG

comparing TIVA with genera anesthesia with inhalation agent

Inhalation agent

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

Group Type: EXPERIMENTAL

TIVA versus Inhalation

Intervention Type: DRUG

comparing TIVA with genera anesthesia with inhalation agent

Interventions

TIVA versus Inhalation

comparing TIVA with genera anesthesia with inhalation agent

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients over 18 years who underwent laparoscopic bariatric surgery

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Tomasz Skladzien

PHD MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jagiellonian University

Krakow, Lesser Poland Voivodeship, Poland

Countries

Poland

Other Identifiers

1072.6120.135.2023

Identifier Type: -

Identifier Source: org_study_id