ObesityOFA VS OBA1NCT07075302
OFA vs OBA in Bariatric Surgery
An observational study of Obesity and Postoperative Pain, run by Hospital HM Nou Delfos at 1 site in Spain.
Trial summary
This study compares two different anesthesia techniques in patients with obesity undergoing bariatric surgery: one that includes opioids (OBA), and one that avoids them completely (OFA). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Postoperative Pain, Bariatric Surgery
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2022to 31 Jan 2024
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (18-65 years) with obesity (BMI ≥ 30 kg/m²) classified as ASA II-III, who underwent laparoscopic bariatric surgery under general anesthesia at HM Nou Delfos between June 2022 and December 2023. Patients were retrospectively assigned to one of two groups based on the anesthetic technique used: opioid-free anesthesia (OFA) or opioid-based anesthesia (OBA).
Who may be able to join
- Body Mass Index (BMI) ≥ 30 kg/m²
- ASA physical status II or III
- Underwent laparoscopic bariatric surgery under general anesthesia at HM Nou Delfos
- Surgery performed between June 1, 2022 and December 31, 2023
Who cannot join
- Chronic pain patients on high-dose opioids
- Known allergy to any anesthetic drug used in the study
- Severe hepatic (e.g., cirrhosis with portal hypertension) or renal insufficiency
- Untreated coagulopathy
- Active alcohol or drug abuse
- Uncontrolled or severe psychiatric illness
- Intraoperative complications requiring deviation from planned anesthetic technique
- Postoperative morphine use exceeding institutional norms for bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Morphine Requirements Between an Opioid-Based and an Opioid-Free Anesthesia Technique in Morbidly Obese Patients Undergoing Bariatric Surgery
This study compares two different anesthesia techniques in patients with obesity undergoing bariatric surgery: one that includes opioids (OBA), and one that avoids them completely (OFA). The main goal is to determine whether avoiding opioids during surgery leads to lower postoperative morphine requirements and fewer side effects. Researchers reviewed medical records of 70 patients who had bariatric surgery between June 2022 and December 2023 at a hospital in Spain. The study evaluates pain levels, sedation, complications, and total morphine use in the first 48 hours after surgery.
Read the detailed description
This is a single-center, retrospective, observational cohort study conducted at Hospital HM Nou Delfos (Barcelona, Spain). The aim is to compare postoperative opioid requirements and outcomes in patients with morbid obesity undergoing laparoscopic bariatric surgery, according to the intraoperative anesthesia technique used.
Two anesthetic strategies were evaluated:
Opioid-Free Anesthesia (OFA): Total intravenous anesthesia (TIVA) without opioids, using agents such as propofol, ketamine, dexmedetomidine, lidocaine and magnesium.
Opioid-Based Anesthesia (OBA): TIVA including opioids, following institutional standards.
Medical records of 70 patients (35 in each group) who underwent surgery between June 2022 and December 2023 were analyzed. Key data extracted included demographics, surgical duration, anesthetic drugs used, intraoperative complications, pain scores (VAS at 1, 2, 4, 24, and 48 hours), sedation levels (RAMSAY scale), adverse effects (e.g., nausea, vomiting, ileus, hypotension), and morphine consumption.
The primary outcome is total morphine use within the first 48 hours postoperatively. Secondary outcomes include pain scores, adverse events, time to awakening, and hospital length of stay. Statistical analysis was performed using descriptive and inferential methods, including regression models adjusted for age, sex, BMI, and comorbidities.
This study provides real-world evidence on the clinical impact of opioid-free anesthesia in bariatric patients, aiming to improve perioperative safety and enhance postoperative recovery.
- Conditions
- Obesity, Postoperative Pain, Bariatric Surgery, Opioid-free Anesthesia
- Keywords
- Opioid-Free Anesthesia, Bariatric Surgery, opioid-based anesthesia, morphine consumption, TIVA, multimodal analgesia
- Medical subject headings
- Obesity, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OFA Group | Patients who received opioid-free total intravenous anesthesia (TIVA) for bariatric surgery, including propofol, lidocaine, ketamine, dexmedetomidine and magnesium, with no intraoperative opioids. | |
| OBA Group | Patients who received opioid-based total intravenous anesthesia (TIVA) for bariatric surgery, including propofol and intraoperative opioids such as fentanyl, remifentanil and morphine, following standard practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative morphine consumption (mg)
Cumulative amount of morphine (in milligrams) administered within the first 48 hours after surgery, as recorded in the post-anesthesia care unit and inpatient medical records.
Measured: From 0 to 48 hours after surgery
Secondary outcomes (5)
Pain intensity (VAS)
Pain evaluated using the Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain), both at rest and with movement.
Measured: At 1, 2, 4, 24, and 48 hours postoperatively
Sedation level (RAMSAY scale)
Sedation assessed using the Ramsay Sedation Scale, ranging from 1 (anxious/agitated) to 6 (no response to stimuli).
Measured: From 0 to 48 hours after surgery
Incidence of adverse events
Number of patients experiencing side effects such as nausea, vomiting, pruritus, hypotension, bradycardia, ileus, or urinary retention.
Measured: Up to 48 hours after surgery
Length of hospital stay
Total duration of hospital stay in days, calculated from the day of surgery to discharge date.
Measured: From surgery until discharge (up to 7 days)
Time to awakening
Time in minutes from the end of surgery until patient opens eyes or responds to verbal commands.
Measured: Intraoperative period until recovery (measured at end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Jun 2022
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital HM Nou Delfos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HIPÓLITO LABANDEYRA GONZALEZ, Hospital HM Nou Delfos
- Investigators
- Gregory Contreras-Pérez, Anesthesiologist, Principal investigator, Hospital HM NouDelfos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075302
- Sponsor's protocol ID
- 25.04.2517-GHM
- Acronym
- OFA VS OBA1
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a retrospective study involving patient health records. Due to ethical and privacy regulations, individual participant data cannot be shared publicly. Access is restricted to the research team as approved by the ethics committee.
Publications
Kumar A, Kohli A. Comeback of ketamine: resurfacing facts and dispelling myths. Korean J Anesthesiol. 2021 Apr;74(2):103-114. doi: 10.4097/kja.20663. Epub 2021 Jan 11.
PubMed 33423410Chia PA, Cannesson M, Bui CCM. Opioid free anesthesia: feasible? Curr Opin Anaesthesiol. 2020 Aug;33(4):512-517. doi: 10.1097/ACO.0000000000000878.
PubMed 32530891Roesslein M, Chung F. Obstructive sleep apnoea in adults: peri-operative considerations: A narrative review. Eur J Anaesthesiol. 2018 Apr;35(4):245-255. doi: 10.1097/EJA.0000000000000765.
PubMed 29300271Hofer RE, Sprung J, Sarr MG, Wedel DJ. Anesthesia for a patient with morbid obesity using dexmedetomidine without narcotics. Can J Anaesth. 2005 Feb;52(2):176-80. doi: 10.1007/BF03027725.
PubMed 15684259Mantz J, Josserand J, Hamada S. Dexmedetomidine: new insights. Eur J Anaesthesiol. 2011 Jan;28(1):3-6. doi: 10.1097/EJA.0b013e32833e266d.
PubMed 20881501Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.
PubMed 19713256Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.
PubMed 26275092Fuchs-Buder T, Schmartz D, Baumann C, Hilt L, Nomine-Criqui C, Meistelman C, Brunaud L. Deep neuromuscular blockade improves surgical conditions during gastric bypass surgery for morbid obesity: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):486-493. doi: 10.1097/EJA.0000000000000996.
PubMed 30985536Ingrande J, Lemmens HJ. Dose adjustment of anaesthetics in the morbidly obese. Br J Anaesth. 2010 Dec;105 Suppl 1:i16-23. doi: 10.1093/bja/aeq312.
PubMed 21148651Raveendran R, Wong J, Singh M, Wong DT, Chung F. Obesity hypoventilation syndrome, sleep apnea, overlap syndrome: perioperative management to prevent complications. Curr Opin Anaesthesiol. 2017 Feb;30(1):146-155. doi: 10.1097/ACO.0000000000000421.
PubMed 27792079Schumann R, Shikora SA, Sigl JC, Kelley SD. Association of metabolic syndrome and surgical factors with pulmonary adverse events, and longitudinal mortality in bariatric surgery. Br J Anaesth. 2015 Jan;114(1):83-90. doi: 10.1093/bja/aeu362. Epub 2014 Oct 13.
PubMed 25311316Sultana A, Torres D, Schumann R. Special indications for Opioid Free Anaesthesia and Analgesia, patient and procedure related: Including obesity, sleep apnoea, chronic obstructive pulmonary disease, complex regional pain syndromes, opioid addiction and cancer surgery. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):547-560. doi: 10.1016/j.bpa.2017.11.002. Epub 2017 Nov 16.
PubMed 29739543de Raaff CAL, de Vries N, van Wagensveld BA. Obstructive sleep apnea and bariatric surgical guidelines: summary and update. Curr Opin Anaesthesiol. 2018 Feb;31(1):104-109. doi: 10.1097/ACO.0000000000000542.
PubMed 29176373Malo-Manso A, Ramirez-Aliaga M, Sepulveda-Haro E, Diaz-Crespo J, Escalona-Belmonte JJ, Guerrero-Orriach JL. Opioid-free anesthesia for open radical cystectomy in morbid obesity. Rev Esp Anestesiol Reanim (Engl Ed). 2021 Sep 23:S0034-9356(21)00134-1. doi: 10.1016/j.redar.2021.03.007. Online ahead of print. English, Spanish.
PubMed 34565571Al-Hasani R, Bruchas MR. Molecular mechanisms of opioid receptor-dependent signaling and behavior. Anesthesiology. 2011 Dec;115(6):1363-81. doi: 10.1097/ALN.0b013e318238bba6.
PubMed 22020140
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Morphine Requirements Between an Opioid-Based and an Opioid-Free Anesthesia Technique in Morbidly Obese Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07075302
- Acronym / sponsor ID
- OFA VS OBA1 / 25.04.2517-GHM
- Conditions
- Obesity, Postoperative Pain, Bariatric Surgery, Opioid-free Anesthesia
- Keywords
- Opioid-Free Anesthesia, Bariatric Surgery, opioid-based anesthesia, morphine consumption, TIVA, multimodal analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospital HM Nou DelfosUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 20 Jul 2025 (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.
This study compares two different anesthesia techniques in patients with obesity undergoing bariatric surgery: one that includes opioids (OBA), and one that avoids them completely (OFA). The main goal is to determine whether avoiding opioids during surgery leads to lower postoperative morphine requirements and fewer side effects. Researchers reviewed medical records of 70 patients who had bariatric surgery between June 2022 and December 2023 at a hospital in Spain. The study evaluates pain levels, sedation, complications, and total morphine use in the first 48 hours after surgery.
Detailed description
This is a single-center, retrospective, observational cohort study conducted at Hospital HM Nou Delfos (Barcelona, Spain). The aim is to compare postoperative opioid requirements and outcomes in patients with morbid obesity undergoing laparoscopic bariatric surgery, according to the intraoperative anesthesia technique used.
Two anesthetic strategies were evaluated:
Opioid-Free Anesthesia (OFA): Total intravenous anesthesia (TIVA) without opioids, using agents such as propofol, ketamine, dexmedetomidine, lidocaine and magnesium.
Opioid-Based Anesthesia (OBA): TIVA including opioids, following institutional standards.
Medical records of 70 patients (35 in each group) who underwent surgery between June 2022 and December 2023 were analyzed. Key data extracted included demographics, surgical duration, anesthetic drugs used, intraoperative complications, pain scores (VAS at 1, 2, 4, 24, and 48 hours), sedation levels (RAMSAY scale), adverse effects (e.g., nausea, vomiting, ileus, hypotension), and morphine consumption.
The primary outcome is total morphine use within the first 48 hours postoperatively. Secondary outcomes include pain scores, adverse events, time to awakening, and hospital length of stay. Statistical analysis was performed using descriptive and inferential methods, including regression models adjusted for age, sex, BMI, and comorbidities.
This study provides real-world evidence on the clinical impact of opioid-free anesthesia in bariatric patients, aiming to improve perioperative safety and enhance postoperative recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OFA Group | – | –Patients who received opioid-free total intravenous anesthesia (TIVA) for bariatric surgery, including propofol, lidocaine, ketamine, dexmedetomidine and magnesium, with no intraoperative opioids. |
| OBA Group | – | –Patients who received opioid-based total intravenous anesthesia (TIVA) for bariatric surgery, including propofol and intraoperative opioids such as fentanyl, remifentanil and morphine, following standard practice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18-65 years) with obesity (BMI ≥ 30 kg/m²) classified as ASA II-III, who underwent laparoscopic bariatric surgery under general anesthesia at HM Nou Delfos between June 2022 and December 2023. Patients were retrospectively assigned to one of two groups based on the anesthetic technique used: opioid-free anesthesia (OFA) or opioid-based anesthesia (OBA).
Key inclusion criteria (4 listed)
- Body Mass Index (BMI) ≥ 30 kg/m²
- ASA physical status II or III
- Underwent laparoscopic bariatric surgery under general anesthesia at HM Nou Delfos
- Surgery performed between June 1, 2022 and December 31, 2023
Key exclusion criteria (8 listed)
- Chronic pain patients on high-dose opioids
- Known allergy to any anesthetic drug used in the study
- Severe hepatic (e.g., cirrhosis with portal hypertension) or renal insufficiency
- Untreated coagulopathy
- Active alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total postoperative morphine consumption (mg)
Time frame: From 0 to 48 hours after surgery
Cumulative amount of morphine (in milligrams) administered within the first 48 hours after surgery, as recorded in the post-anesthesia care unit and inpatient medical records.
5 secondary outcomes
Pain intensity (VAS)
Time frame: At 1, 2, 4, 24, and 48 hours postoperatively
Sedation level (RAMSAY scale)
Time frame: From 0 to 48 hours after surgery
Incidence of adverse events
Time frame: Up to 48 hours after surgery
Length of hospital stay
Time frame: From surgery until discharge (up to 7 days)
Time to awakening
Time frame: Intraoperative period until recovery (measured at end of surgery)
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 20 Jul 2025.
- Results publication: PubMed 33423410Kumar A, Kohli A. Comeback of ketamine: resurfacing facts and dispelling myths. Korean J Anesthesiol. 2021 Apr;74(2):103-114. doi: 10.4097/kja.20663. Epub 2021 Jan 11.
- Results publication: PubMed 32530891Chia PA, Cannesson M, Bui CCM. Opioid free anesthesia: feasible? Curr Opin Anaesthesiol. 2020 Aug;33(4):512-517. doi: 10.1097/ACO.0000000000000878.
- Results publication: PubMed 29300271Roesslein M, Chung F. Obstructive sleep apnoea in adults: peri-operative considerations: A narrative review. Eur J Anaesthesiol. 2018 Apr;35(4):245-255. doi: 10.1097/EJA.0000000000000765.
- Results publication: PubMed 15684259Hofer RE, Sprung J, Sarr MG, Wedel DJ. Anesthesia for a patient with morbid obesity using dexmedetomidine without narcotics. Can J Anaesth. 2005 Feb;52(2):176-80. doi: 10.1007/BF03027725.
- Results publication: PubMed 20881501Mantz J, Josserand J, Hamada S. Dexmedetomidine: new insights. Eur J Anaesthesiol. 2011 Jan;28(1):3-6. doi: 10.1097/EJA.0b013e32833e266d.
- Results publication: PubMed 19713256Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.
- Results publication: PubMed 26275092Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.
- Results publication: PubMed 30985536Fuchs-Buder T, Schmartz D, Baumann C, Hilt L, Nomine-Criqui C, Meistelman C, Brunaud L. Deep neuromuscular blockade improves surgical conditions during gastric bypass surgery for morbid obesity: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):486-493. doi: 10.1097/EJA.0000000000000996.
- Results publication: PubMed 21148651Ingrande J, Lemmens HJ. Dose adjustment of anaesthetics in the morbidly obese. Br J Anaesth. 2010 Dec;105 Suppl 1:i16-23. doi: 10.1093/bja/aeq312.
- Results publication: PubMed 27792079Raveendran R, Wong J, Singh M, Wong DT, Chung F. Obesity hypoventilation syndrome, sleep apnea, overlap syndrome: perioperative management to prevent complications. Curr Opin Anaesthesiol. 2017 Feb;30(1):146-155. doi: 10.1097/ACO.0000000000000421.
- Results publication: PubMed 25311316Schumann R, Shikora SA, Sigl JC, Kelley SD. Association of metabolic syndrome and surgical factors with pulmonary adverse events, and longitudinal mortality in bariatric surgery. Br J Anaesth. 2015 Jan;114(1):83-90. doi: 10.1093/bja/aeu362. Epub 2014 Oct 13.
- Results publication: PubMed 29739543Sultana A, Torres D, Schumann R. Special indications for Opioid Free Anaesthesia and Analgesia, patient and procedure related: Including obesity, sleep apnoea, chronic obstructive pulmonary disease, complex regional pain syndromes, opioid addiction and cancer surgery. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):547-560. doi: 10.1016/j.bpa.2017.11.002. Epub 2017 Nov 16.
- Individual participant dataSharing planned: No. This is a retrospective study involving patient health records. Due to ethical and privacy regulations, individual participant data cannot be shared publicly. Access is restricted to the research team as approved by the ethics committee.
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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. This study is not recruiting at the moment.
Gregory Contreras-Pérez, Anesthesiologist principal investigator
Hospital HM NouDelfos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Postoperative Pain, run by Hospital HM Nou Delfos at 1 site in Spain.
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 4 inclusion and 8 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 20 Jul 2025. 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 Spain. 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?
Total postoperative morphine consumption (mg) (time frame: From 0 to 48 hours after surgery). 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 NCT07075302, which also lists 20 linked publications.
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 20 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.