ObesityPhase 4SWAPNCT07748247
Swap Anesthetic Versus Continuous Desflurane in Adults Undergoing Bariatric Surgery
A Phase 4 study testing Desflurane and Sevoflurane-Desflurane in people with Obesity and Bariatric Surgery, run by Clínica Dávila at 1 site in Chile.
Trial summary
This randomized, parallel-group, non-inferiority clinical trial aims to evaluate whether an anesthetic swap strategy consisting of sevoflurane followed by desflurane 30 minutes before the end of surgery is non-inferior to continuous desflurane anesthesia with respect to extubation time in adults undergoing elective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Bariatric Surgery
- What is being tested?
- Desflurane and Sevoflurane-Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChile
- Study dates
- 3 Aug 2026to Apr 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Scheduled for elective laparoscopic gastric bypass surgery.
- Body mass index between 30 and 50 kg/m².
- American Society of Anesthesiologists physical status II or III.
- Able and willing to provide written informed consent.
Who cannot join
- Surgical procedure lasting less than 2 hours.
- Body mass index greater than 50 kg/m².
- Significant cardiac disease.
- Moderate or severe obstructive respiratory disease, including uncontrolled asthma or chronic obstructive pulmonary disease.
- Pregnancy or breastfeeding.
- Known allergy or contraindication to medications used during the intraoperative period.
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- Personal or family history of malignant hyperthermia.
- Active illicit drug use or substance dependence.
- Advanced chronic kidney disease, defined as an estimated glomerular filtration rate below 60 mL/min.
- Myasthenia gravis or another neuromuscular junction disorder.
- Severe cognitive or psychiatric disorder.
- Refusal to participate or withdrawal of informed consent at any time.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
Clínica Dávila
Santiago, Santiago Metropolitan, 8431657
Alejandra Alejandra Rivera, MsC Epidemiology, 930363776, alejandra.rivera@davila.cl
About this study
Official title: Desflurane Versus Sevoflurane-Desflurane Swap in Adults Undergoing Bariatric Surgery: A Randomized Non-Inferiority Trial on Extubation Time
This randomized, parallel-group, non-inferiority clinical trial aims to evaluate whether an anesthetic swap strategy consisting of sevoflurane followed by desflurane 30 minutes before the end of surgery is non-inferior to continuous desflurane anesthesia with respect to extubation time in adults undergoing elective laparoscopic bariatric surgery. Secondary outcomes include time to achieve a Patient State Index (PSi) greater than 80, time to achieve an Aldrete score of at least 8, incidence of postoperative nausea and vomiting, post-anesthesia care unit length of stay, and desflurane-related costs.
Read the detailed description
Obesity is associated with an increased risk of postoperative respiratory complications, making rapid and safe anesthetic recovery particularly important in patients undergoing bariatric surgery. Desflurane provides rapid emergence because of its favorable pharmacokinetic profile but is associated with higher cost and greater environmental impact than sevoflurane.
This prospective, randomized, parallel-group, non-inferiority trial will compare two inhalational anesthetic strategies in adults undergoing elective laparoscopic bariatric surgery at Clínica Dávila. Participants will be randomly assigned in a 1:1 ratio to receive either continuous desflurane throughout the procedure or a swap strategy consisting of sevoflurane during most of the operation followed by desflurane beginning 30 minutes before surgical closure.
The primary outcome is extubation time, defined as the interval from discontinuation of inhaled anesthetic agents to removal of the endotracheal tube. Secondary outcomes include time to achieve a Patient State Index (PSi) greater than 80, time to achieve an Aldrete score of at least 8 in the post-anesthesia care unit, incidence of postoperative nausea and vomiting, length of stay in the post-anesthesia care unit, and desflurane-related costs. The study is designed to determine whether the swap anesthetic strategy is non-inferior to continuous desflurane while reducing desflurane consumption, with potential benefits for environmental sustainability and healthcare costs.
- Conditions
- Obesity, Bariatric Surgery
- Being tested
- Desflurane, Sevoflurane-Desflurane
- Keywords
- Desflurane, Sevoflurane, General Anesthesia, Bariatric Surgery, Extubation Time, Obesity, Laparoscopic Gastric Bypass, Randomized Trial, Non-Inferiority Trial, Patient State Index
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Desflurane administered as the inhalational anesthetic throughout the surgical procedure.
Sevoflurane-DesfluraneDrug
Sevoflurane administered during the initial phase of surgery followed by desflurane beginning 30 minutes before surgical closure.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Desflurane | Experimental | Participants receive desflurane as the inhalational anesthetic throughout the entire elective laparoscopic bariatric surgery according to the study protocol. Receives: Drug: Desflurane |
| Sevoflurane-Desflurane Swap | Experimental | Participants receive sevoflurane during most of the procedure and are switched to desflurane 30 minutes before the end of surgery according to the study protocol. Receives: Drug: Sevoflurane-Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation Time
Time in seconds from discontinuation of inhaled anesthetic agents to removal of the endotracheal tube.
Measured: Perioperative
Secondary outcomes (5)
Time to Achieve Patient State Index Greater Than 80
Time in seconds from discontinuation of inhaled anesthetic agents until the Patient State Index (PSi) reaches a value greater than 80.
Measured: Perioperative
Postoperative Nausea and Vomiting
Presence of postoperative nausea or vomiting, recorded as a binary outcome of yes or no.
Measured: Up to 24 hours after surgery
Time to Achieve an Aldrete Score of at Least 8
Time in minutes from arrival at the post-anesthesia care unit until the participant achieves an Aldrete score of at least 8 out of 10.
Measured: Up to 24 hours after surgery
Time to Post-Anesthesia Care Unit Discharge Readiness
Time in minutes from arrival at the post-anesthesia care unit until the participant meets the institutional discharge criteria.
Measured: Up to 24 hours after surgery
Desflurane-Related Cost
Estimated cost in Chilean pesos associated with desflurane use. The cost will be calculated according to the total duration of desflurane administration, using an estimated consumption of 0.75 mL per minute and a cost of 415 Chilean pesos per mL. The applied formula will be: duration of desflurane anesthesia in minutes multiplied by 311.25 Chilean pesos.
Measured: Periprocedural (during surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start3 Aug 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either continuous desflurane anesthesia or a sevoflurane-desflurane swap strategy during elective laparoscopic bariatric surgery.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clínica Dávila
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748247
- Sponsor's protocol ID
- CD2026/002
- Acronym
- SWAP
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the study involves clinical data collected at a single institution, and no data-sharing agreement or repository has been established. Only aggregate study results will be reported in scientific publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desflurane Versus Sevoflurane-Desflurane Swap in Adults Undergoing Bariatric Surgery: A Randomized Non-Inferiority Trial on Extubation Time
- ClinicalTrials.gov ID
- NCT07748247
- Acronym / sponsor ID
- SWAP / CD2026/002
- Conditions
- Obesity, Bariatric Surgery
- Keywords
- Desflurane, Sevoflurane, General Anesthesia, Bariatric Surgery, Extubation Time, Obesity, Laparoscopic Gastric Bypass, Randomized Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Clínica DávilaUniversity, hospital or other
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 Aug 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.
This randomized, parallel-group, non-inferiority clinical trial aims to evaluate whether an anesthetic swap strategy consisting of sevoflurane followed by desflurane 30 minutes before the end of surgery is non-inferior to continuous desflurane anesthesia with respect to extubation time in adults undergoing elective laparoscopic bariatric surgery. Secondary outcomes include time to achieve a Patient State Index (PSi) greater than 80, time to achieve an Aldrete score of at least 8, incidence of postoperative nausea and vomiting, post-anesthesia care unit length of stay, and desflurane-related costs.
Detailed description
Obesity is associated with an increased risk of postoperative respiratory complications, making rapid and safe anesthetic recovery particularly important in patients undergoing bariatric surgery. Desflurane provides rapid emergence because of its favorable pharmacokinetic profile but is associated with higher cost and greater environmental impact than sevoflurane.
This prospective, randomized, parallel-group, non-inferiority trial will compare two inhalational anesthetic strategies in adults undergoing elective laparoscopic bariatric surgery at Clínica Dávila. Participants will be randomly assigned in a 1:1 ratio to receive either continuous desflurane throughout the procedure or a swap strategy consisting of sevoflurane during most of the operation followed by desflurane beginning 30 minutes before surgical closure.
The primary outcome is extubation time, defined as the interval from discontinuation of inhaled anesthetic agents to removal of the endotracheal tube. Secondary outcomes include time to achieve a Patient State Index (PSi) greater than 80, time to achieve an Aldrete score of at least 8 in the post-anesthesia care unit, incidence of postoperative nausea and vomiting, length of stay in the post-anesthesia care unit, and desflurane-related costs. The study is designed to determine whether the swap anesthetic strategy is non-inferior to continuous desflurane while reducing desflurane consumption, with potential benefits for environmental sustainability and healthcare costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either continuous desflurane anesthesia or a sevoflurane-desflurane swap strategy during elective laparoscopic bariatric surgery.
| Arm | Type | Receives |
|---|---|---|
| Continuous Desflurane | Experimental | Drug: DesfluraneParticipants receive desflurane as the inhalational anesthetic throughout the entire elective laparoscopic bariatric surgery according to the study protocol. |
| Sevoflurane-Desflurane Swap | Experimental | Drug: Sevoflurane-DesfluraneParticipants receive sevoflurane during most of the procedure and are switched to desflurane 30 minutes before the end of surgery according to the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Scheduled for elective laparoscopic gastric bypass surgery.
- Body mass index between 30 and 50 kg/m².
- American Society of Anesthesiologists physical status II or III.
- Able and willing to provide written informed consent.
Key exclusion criteria (12 listed)
- Surgical procedure lasting less than 2 hours.
- Body mass index greater than 50 kg/m².
- Significant cardiac disease.
- Moderate or severe obstructive respiratory disease, including uncontrolled asthma or chronic obstructive pulmonary disease.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| DesfluraneDesflurane administered as the inhalational anesthetic throughout the surgical procedure. | Drug | Continuous Desflurane |
| Sevoflurane-DesfluraneSevoflurane administered during the initial phase of surgery followed by desflurane beginning 30 minutes before surgical closure. | Drug | Sevoflurane-Desflurane Swap |
Primary outcome
Extubation Time
Time frame: Perioperative
Time in seconds from discontinuation of inhaled anesthetic agents to removal of the endotracheal tube.
5 secondary outcomes
Time to Achieve Patient State Index Greater Than 80
Time frame: Perioperative
Postoperative Nausea and Vomiting
Time frame: Up to 24 hours after surgery
Time to Achieve an Aldrete Score of at Least 8
Time frame: Up to 24 hours after surgery
Time to Post-Anesthesia Care Unit Discharge Readiness
Time frame: Up to 24 hours after surgery
Desflurane-Related Cost
Time frame: Periprocedural (during surgery)
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 5 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because the study involves clinical data collected at a single institution, and no data-sharing agreement or repository has been established. Only aggregate study results will be reported in scientific publications and presentations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desflurane and Sevoflurane-Desflurane in people with Obesity and Bariatric Surgery, run by Clínica Dávila at 1 site in Chile.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 5 Aug 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 Chile. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Magdalena Estefo, MD (+56 9 7986 5505, magdalenaestefo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation Time (time frame: Perioperative). 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 5 Aug 2026.