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

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.

Study Overview

• Status: Completed
• Conditions: Analgesics, Opioid; Anesthesia; Adverse Effect
• Intervention / Treatment: Drug: TIVA versus Inhalation

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.

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 31501
      • Jagiellonian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TIVA; total intravenously anesthetized (infusion of Propofol, Ketamine, Lignocaine and Dexmedetomidine)	Drug: TIVA versus Inhalation; comparing TIVA with genera anesthesia with inhalation agent
Experimental: Inhalation agent; combined general anesthesia (infusion of Ketamine, Lignocaine and Dexmedetomidine and inhalation of Sevoflurane)	Drug: TIVA versus Inhalation; comparing TIVA with genera anesthesia with inhalation agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
presence of PONV in postoperative period	The incidence of postoperative nausea and vomiting (PONV) within the first 24 hours after surgery	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative recovery parameters	the measures of return of gastrointestinal function such as volume of oral fluids consumed	1 day
Opioid consumption	Postoperative pain levels at 1, 2, 6, 12, and 24 hours were assessed by NRS	1 day

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1072.6120.135.2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No