Swap Anesthetic Versus Continuous Desflurane in Adults Undergoing Bariatric Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Desflurane, Sevoflurane-Desflurane.
- Who it may be relevant to
- Registry conditions: Obesity, Bariatric Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Chile
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Desflurane Versus Sevoflurane-Desflurane Swap in Adults Undergoing Bariatric Surgery: A Randomized Non-Inferiority Trial on Extubation Time
Overview
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.
Interventions
- Drug Desflurane
Desflurane administered as the inhalational anesthetic throughout the surgical procedure. - Drug Sevoflurane-Desflurane
Sevoflurane administered during the initial phase of surgery followed by desflurane beginning 30 minutes before surgical closure.
Primary outcome measures
- Extubation Time [Time frame: Perioperative]
Secondary outcome measures (5)
- 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)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Chile · 1 center
- Clínica Dávila — Santiago
Identifiers
NCT: NCT07748247 · CD2026/002