Bariatric Surgery, Obesity
Conditions
Keywords
Desflurane, Sevoflurane, General Anesthesia, Bariatric Surgery, Extubation Time, Obesity, Laparoscopic Gastric Bypass, Randomized Trial, Non-Inferiority Trial, Patient State Index
Brief 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 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
DRUGDesflurane
Desflurane administered as the inhalational anesthetic throughout the surgical procedure.
DRUGSevoflurane-Desflurane
Sevoflurane administered during the initial phase of surgery followed by desflurane beginning 30 minutes before surgical closure.
Sponsors
Clínica Dávila
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and postoperative outcome assessors are blinded to treatment allocation. The anesthesiologist administering the intervention is not blinded because of the nature of the anesthetic techniques
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extubation Time | Perioperative | Time in seconds from discontinuation of inhaled anesthetic agents to removal of the endotracheal tube. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achieve Patient State Index Greater Than 80 | Perioperative | Time in seconds from discontinuation of inhaled anesthetic agents until the Patient State Index (PSi) reaches a value greater than 80. |
| Postoperative Nausea and Vomiting | Up to 24 hours after surgery | Presence of postoperative nausea or vomiting, recorded as a binary outcome of yes or no. |
| Time to Achieve an Aldrete Score of at Least 8 | Up to 24 hours after surgery | 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. |
| Time to Post-Anesthesia Care Unit Discharge Readiness | Up to 24 hours after surgery | Time in minutes from arrival at the post-anesthesia care unit until the participant meets the institutional discharge criteria. |
| Desflurane-Related Cost | Periprocedural (during surgery) | 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. |
Countries
Chile
Contacts
CONTACTMagdalena Estefo, MD
Outcome results
None listed