Swap Anesthetic Versus Continuous Desflurane in Adults Undergoing Bariatric Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorClínica Dávila
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Desflurane
DrugDesflurane administered as the inhalational anesthetic throughout the surgical procedure.
Sevoflurane-Desflurane
DrugSevoflurane administered during the initial phase of surgery followed by desflurane beginning 30 minutes before surgical closure.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Continuous DesfluraneExperimental treatment 1 intervention
Group B: Sevoflurane-Desflurane SwapExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Extubation Time
Time in seconds from discontinuation of inhaled anesthetic agents to removal of the endotracheal tube.
Time frame
PerioperativeSecondary outcomes
1
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
Perioperative2
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 surgery3
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 surgery4
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 surgerySponsors and contacts
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Source ClinicalTrials.gov
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