Analgesics, OpioidNCT06390046
Comparison of Total Intravenous Anesthesia and Inhalational Anesthesia in Opioid-Free Anesthesia for Bariatric Surgery: A Randomized Controlled Trial
A study testing TIVA versus Inhalation in people with Analgesics, Opioid and Anesthesia; Adverse Effect, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Analgesics, Opioid, Anesthesia; Adverse Effect
- What is being tested?
- TIVA versus Inhalation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 sitePoland
- Study dates
- 30 Apr 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years who underwent laparoscopic bariatric surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- TIVA versus Inhalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVA versus InhalationDrug
comparing TIVA with genera anesthesia with inhalation agent
| Study group | Role | What they receive |
|---|---|---|
| TIVA | Active comparator | total intravenously anesthetized (infusion of Propofol, Ketamine, Lignocaine and Dexmedetomidine) Receives: Drug: TIVA versus Inhalation |
| Inhalation agent | Experimental | combined general anesthesia (infusion of Ketamine, Lignocaine and Dexmedetomidine and inhalation of Sevoflurane) Receives: Drug: TIVA versus Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of PONV in postoperative period
The incidence of postoperative nausea and vomiting (PONV) within the first 24 hours after surgery
Measured: 1 day
Secondary outcomes (2)
Postoperative recovery parameters
the measures of return of gastrointestinal function such as volume of oral fluids consumed
Measured: 1 day
Opioid consumption
Postoperative pain levels at 1, 2, 6, 12, and 24 hours were assessed by NRS
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start30 Apr 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesics, OpioidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Skladzien, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390046
- Sponsor's protocol ID
- 1072.6120.135.2023
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maciejewski P, Skladzien T, Cicio M, Tabin L, Lonc T, Szkudlarek O, Klimczyk T, Kwinta A, Zmuda A, Drygalski T, Major P, Terlecki M. Comparison of Opioid-Free Versions of Total Intravenous Anesthesia and Inhalational Anesthesia in Bariatric Surgery: A Randomized Controlled Trial. Obes Surg. 2026 Jul 20. doi: 10.1007/s11695-026-08866-0. Online ahead of print.
PubMed 42472775
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Total Intravenous Anesthesia and Inhalational Anesthesia in Opioid-Free Anesthesia for Bariatric Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06390046
- Acronym / sponsor ID
- 1072.6120.135.2023
- Conditions
- Analgesics, Opioid, Anesthesia; Adverse Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TIVA | Active comparator | Drug: TIVA versus Inhalationtotal intravenously anesthetized (infusion of Propofol, Ketamine, Lignocaine and Dexmedetomidine) |
| Inhalation agent | Experimental | Drug: TIVA versus Inhalationcombined general anesthesia (infusion of Ketamine, Lignocaine and Dexmedetomidine and inhalation of Sevoflurane) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years who underwent laparoscopic bariatric surgery
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIVA versus Inhalationcomparing TIVA with genera anesthesia with inhalation agent | Drug | Inhalation agent, TIVA |
Primary outcome
presence of PONV in postoperative period
Time frame: 1 day
The incidence of postoperative nausea and vomiting (PONV) within the first 24 hours after surgery
2 secondary outcomes
Postoperative recovery parameters
Time frame: 1 day
Opioid consumption
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 42472775Maciejewski P, Skladzien T, Cicio M, Tabin L, Lonc T, Szkudlarek O, Klimczyk T, Kwinta A, Zmuda A, Drygalski T, Major P, Terlecki M. Comparison of Opioid-Free Versions of Total Intravenous Anesthesia and Inhalational Anesthesia in Bariatric Surgery: A Randomized Controlled Trial. Obes Surg. 2026 Jul 20. doi: 10.1007/s11695-026-08866-0. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Analgesics, Opioid
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingPhase 3
Safety and Analgesic Efficacy of the Biased μ-Opioid Receptor Agonist Tegileridine for Post-Operative Analgesia in Patients Undergoing Bariatric Surgery
Pain Management, Overweight , Obesity
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIVA versus Inhalation in people with Analgesics, Opioid and Anesthesia; Adverse Effect, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of PONV in postoperative period (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06390046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.