Clínica Dávila
Santiago, Santiago Metropolitan, 8431657, Chile
NCT Number: NCT07748247
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Santiago, Santiago Metropolitan, 8431657, Chile
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Perioperative
Time in seconds from discontinuation of inhaled anesthetic agents to removal of the endotracheal tube.
Time frame: Perioperative
Time in seconds from discontinuation of inhaled anesthetic agents until the Patient State Index (PSi) reaches a value greater than 80.
Time frame: Up to 24 hours after surgery
Presence of postoperative nausea or vomiting, recorded as a binary outcome of yes or no.
Time frame: 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 frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Clínica Dávila
Other
Desflurane Versus Sevoflurane-Desflurane Swap in Adults Undergoing Bariatric Surgery: A Randomized Non-Inferiority Trial on Extubation Time
Acronym: SWAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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