Opioid UseNCT07568938
Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA for Bariatric Surgery
A study testing opioid free anesthesia and Opiod Free Anesthesia with TCI ELEVELD in people with Opioid Use and Bariatric Surgery Candidate, run by G.Gennimatas General Hospital at 1 site in Greece.
Trial summary
The goal of this clinical trial is to compare the effects of Opioid Free Anesthesia (OFA) with and without volatile anesthetics (in this case desflurane) in patients undergoing bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use, Bariatric Surgery Candidate, TCI Eleveld
- What is being tested?
- opioid free anesthesia and Opiod Free Anesthesia with TCI ELEVELD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- 10 Jan 2024to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- ASA II-III
- Morbid obesity confirmed diagnosis and approval for surgical treatment
- Laparoscopic sleeve gastrectomy (LSG) or Gastric By pass (R-Y By pass /SASI/SADI AND one anastomosis by pass )
- Preop respiratrory assessment conducted
- Adequate organ and bone marrow function
Who cannot join
- Patients declining or withdrawing consent
- Patients unsuitabe with regards to compliance to treatment, according to the researcher's assessment
- Bradycardia, AV block, , postural hypotension
- QTcF>470msec
- Known allergy or hypersensitiity to any of the medications administered
- Stop-BANG score >6
Show all 10Show fewer
- Intraoperative administration of more than 8mg of prednisolone or equivalent
- Patients who have received corticosteroids for durations >3 weeks at any point in their lifetime
- Participation in other clinical trial for experimental product administered post operatively
- Diagnosis of depression
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
General Hospital of Athens G. Gennimatas
Athens, 11527
Panagiotis Chatzistavridis, 00306972871556, p.chatzistavridis@gna-gennimatas.gr
Panagiotis Chatzistavridis
About this study
Official title: Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA TCI ELEVELD Model for Bariatric Surgery
The goal of this clinical trial is to compare the effects of Opioid Free Anesthesia (OFA) with and without volatile anesthetics (in this case desflurane) in patients undergoing bariatric surgery. The main question it aims to answer :
-Will there be a difference in the perioperative stress between patients receiving OFA with and without desflurane?
Participants will undergoing sleeve gastrectomy or gastric by pass, will be administered OFA with and without desflurane and blood tests (cortisole, ACTH,dopamine, PRL, adrenaline, noradrenaline, lactate) will be collected perioperatively to compare stress in the two groups.
- Conditions
- Opioid Use, Bariatric Surgery Candidate, TCI Eleveld, Obesity
- Being tested
- opioid free anesthesia, Opiod Free Anesthesia with TCI ELEVELD
- Keywords
- Morbid Obesity, Opioid Free Anesthesia, Nociception Level, Analgesia, Bariatric Surgery, Eleveld Model TCI
- Medical subject headings
- Obesity, Obesity, Morbid, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid free anesthesiaDrug
Also called Desflurane
OFA with Desflurane
Opiod Free Anesthesia with TCI ELEVELDDrug
OFA without Desflurane use TCI Eleveld Model
| Study group | Role | What they receive |
|---|---|---|
| DOFA | Active comparator | This arm will receive:
Anesthesia Induction
* 40 mg/kg Magnesium sulfate in 100 ml N/S infusion
* 1 mcg/kg Dexmedetomidine, max total dose 100mcg in 50 ml N/S infusion
* 0.3 mg/kg Ketamine
* 0.2 ml/kg of the Mulimix regimen in 100 ml N/S infusion as a bolus (The -Mulimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine)
* 2-3mg/kg Propofol (for introduction )
* 4 mg Ondansetron
* 8mg Dexamethasone
* 0,9-1 mg/kg Rocuronium
* 40mg Parecoxib
Anesthesia Maintenance
* 0.2 ml/kg/h of the Multimix regimen in 100 ml N/S
* Desflurane
* Fentanyl rescue dose (1mcg/kg)
PostOp Analgesia
* Paracetamol 1gx4
* Parecoxib 40mg 1x2
* Tramadol 100mg (For pain, the patient may take a rescue medication as needed) Receives: Drug: opioid free anesthesia |
| TIVOFA | Active comparator | This arm will receive:
Anesthesia Induction
* 40 mg/kg Magnesium sulfate in 100 ml N/S infusion
* 1 mcg/kg Dexmedetomidine, max total dose 100mcg in 50 ml N/S infusion
* 0.3 mg/kg Ketamine
* 0.2 ml/kg of the Mulimix regimen in 100 ml N/S infusion as a bolus (The -Mulimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine)
* Propofol Eleveld TCI model Start bolus 3mcg/ml and titrated according to EEG monitoring
* 4 mg Ondansetron
* 8mg Dexamethasone
* 0,9-1 mg/kg Rocuronium
* 40mg Parecoxib
Anesthesia Maintenance
* 0.2 ml/kg/h of the Multimix regimen in 100 ml N/S
* Fentanyl rescue dose (1mcg/kg)
PostOp Analgesia
* Paracetamol 1gx4
* Parecoxib 40mg 1x2
* Tramadol 100mg (For pain, the patient may take a rescue medication as needed) Receives: Drug: Opiod Free Anesthesia with TCI ELEVELD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative trend of Cortisole
Measured: At baseline, at the end of the operation, 24 hours after surgery]
Perioperative trend of Adrenaline
Measured: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Noradrenaline
Measured: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Dopamine
Measured: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Prolactine
Measured: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of ACTH
Measured: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Lactate
Measured: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
Secondary outcomes (3)
Plasma levels of Propofol for patients receiving Propofol TCI
Measured: Immediately after extubation
Anesthesia related adverse effects reported, including intraoperative hemodynamic instability, postoperative hypoxemia, nausea and vomit
Measured: Baseline (preoperative), immediately postoperatively, and 24 hours postoperatively During surgery and through 24 hours after surgery, Immediately after extubation Up to 24 hours postoperatively, DAY 2 DAY 15 and DAY 30 postoperative (QoR-40)
Long-term and short-term quality of anesthesia recovery
Evaluation through the use of questionnaires QoR 40
Measured: Post operatively Day 1, Day 2 Day 15 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start10 Jan 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G.Gennimatas General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Principal investigator, Panagiotis Chatzistavridis, G.Gennimatas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568938
- Sponsor's protocol ID
- 372/5.1.2024
- Status last verified
- May 2026
- First submitted
- 25 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA TCI ELEVELD Model for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07568938
- Acronym / sponsor ID
- 372/5.1.2024
- Conditions
- Opioid Use, Bariatric Surgery Candidate, TCI Eleveld, Obesity
- Keywords
- Morbid Obesity, Opioid Free Anesthesia, Nociception Level, Analgesia, Bariatric Surgery, Eleveld Model TCI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- G.Gennimatas General HospitalUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 6 May 2026 (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.
The goal of this clinical trial is to compare the effects of Opioid Free Anesthesia (OFA) with and without volatile anesthetics (in this case desflurane) in patients undergoing bariatric surgery. The main question it aims to answer :
-Will there be a difference in the perioperative stress between patients receiving OFA with and without desflurane?
Participants will undergoing sleeve gastrectomy or gastric by pass, will be administered OFA with and without desflurane and blood tests (cortisole, ACTH,dopamine, PRL, adrenaline, noradrenaline, lactate) will be collected perioperatively to compare stress in the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DOFA | Active comparator | Drug: opioid free anesthesiaThis arm will receive: Anesthesia Induction * 40 mg/kg Magnesium sulfate in 100 ml N/S infusion * 1 mcg/kg Dexmedetomidine, max total dose 100mcg in 50 ml N/S infusion * 0.3 mg/kg Ketamine * 0.2 ml/kg of the Mulimix regimen in 100 ml N/S infusion as a bolus (The -Mulimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine) * 2-3mg/kg Propofol (for introduction ) * 4 mg Ondansetron * 8mg Dexamethasone * 0,9-1 mg/kg Rocuronium * 40mg Parecoxib Anesthesia Maintenance * 0.2 ml/kg/h of the Multimix regimen in 100 ml N/S * Desflurane * Fentanyl rescue dose (1mcg/kg) PostOp Analgesia * Paracetamol 1gx4 * Parecoxib 40mg 1x2 * Tramadol 100mg (For pain, the patient may take a rescue medication as needed) |
| TIVOFA | Active comparator | Drug: Opiod Free Anesthesia with TCI ELEVELDThis arm will receive: Anesthesia Induction * 40 mg/kg Magnesium sulfate in 100 ml N/S infusion * 1 mcg/kg Dexmedetomidine, max total dose 100mcg in 50 ml N/S infusion * 0.3 mg/kg Ketamine * 0.2 ml/kg of the Mulimix regimen in 100 ml N/S infusion as a bolus (The -Mulimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine) * Propofol Eleveld TCI model Start bolus 3mcg/ml and titrated according to EEG monitoring * 4 mg Ondansetron * 8mg Dexamethasone * 0,9-1 mg/kg Rocuronium * 40mg Parecoxib Anesthesia Maintenance * 0.2 ml/kg/h of the Multimix regimen in 100 ml N/S * Fentanyl rescue dose (1mcg/kg) PostOp Analgesia * Paracetamol 1gx4 * Parecoxib 40mg 1x2 * Tramadol 100mg (For pain, the patient may take a rescue medication as needed) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent
- ASA II-III
- Morbid obesity confirmed diagnosis and approval for surgical treatment
- Laparoscopic sleeve gastrectomy (LSG) or Gastric By pass (R-Y By pass /SASI/SADI AND one anastomosis by pass )
- Preop respiratrory assessment conducted
Key exclusion criteria (10 listed)
- Patients declining or withdrawing consent
- Patients unsuitabe with regards to compliance to treatment, according to the researcher's assessment
- Bradycardia, AV block, , postural hypotension
- QTcF>470msec
- Known allergy or hypersensitiity to any of the medications administered
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 |
|---|---|---|
| opioid free anesthesiaAlso: DesfluraneOFA with Desflurane | Drug | DOFA |
| Opiod Free Anesthesia with TCI ELEVELDOFA without Desflurane use TCI Eleveld Model | Drug | TIVOFA |
Primary outcome
Perioperative trend of Cortisole
Time frame: At baseline, at the end of the operation, 24 hours after surgery]
Perioperative trend of Adrenaline
Time frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Noradrenaline
Time frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Dopamine
Time frame: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Prolactine
Time frame: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of ACTH
Time frame: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
Perioperative trend of Lactate
Time frame: Time Frame: At baseline, at the end of the operation, 24 hours after surgery
3 secondary outcomes
Plasma levels of Propofol for patients receiving Propofol TCI
Time frame: Immediately after extubation
Anesthesia related adverse effects reported, including intraoperative hemodynamic instability, postoperative hypoxemia, nausea and vomit
Time frame: Baseline (preoperative), immediately postoperatively, and 24 hours postoperatively During surgery and through 24 hours after surgery, Immediately after extubation Up to 24 hours postoperatively, DAY 2 DAY 15 and DAY 30 postoperative (QoR-40)
Long-term and short-term quality of anesthesia recovery
Time frame: Post operatively Day 1, Day 2 Day 15 and Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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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.
General Hospital of Athens G. Gennimatas
Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing opioid free anesthesia and Opiod Free Anesthesia with TCI ELEVELD in people with Opioid Use and Bariatric Surgery Candidate, run by G.Gennimatas General Hospital at 1 site in Greece.
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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 6 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative trend of Cortisole (time frame: At baseline, at the end of the operation, 24 hours after surgery]). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2026.