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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
82
Desflurane administered as the inhalational anesthetic throughout the surgical procedure.
Sevoflurane administered during the initial phase of surgery followed by desflurane beginning 30 minutes before surgical closure.
Clínica Dávila
Santiago, Santiago Metropolitan, Chile
Extubation Time
Time in seconds from discontinuation of inhaled anesthetic agents to removal of the endotracheal tube.
Time frame: Perioperative
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.
Time frame: Perioperative
Postoperative Nausea and Vomiting
Presence of postoperative nausea or vomiting, recorded as a binary outcome of yes or no.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Periprocedural (during surgery)
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