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NCT Number: NCT07748247

Swap Anesthetic Versus Continuous Desflurane in Adults Undergoing Bariatric Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clínica Dávila

Santiago, Santiago Metropolitan, 8431657, Chile

Location contact

Alejandra Alejandra Rivera, MsC Epidemiology

CONTACT

[email protected]

930363776

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Desflurane

Drug

Desflurane administered as the inhalational anesthetic throughout the surgical procedure.

Sevoflurane-Desflurane

Drug

Sevoflurane administered during the initial phase of surgery followed by desflurane beginning 30 minutes before surgical closure.

Primary outcomes

  1. Extubation Time

    Time frame: Perioperative

    Time in seconds from discontinuation of inhaled anesthetic agents to removal of the endotracheal tube.

Secondary outcomes

  1. Time to Achieve Patient State Index Greater Than 80

    Time frame: Perioperative

    Time in seconds from discontinuation of inhaled anesthetic agents until the Patient State Index (PSi) reaches a value greater than 80.

  2. Postoperative Nausea and Vomiting

    Time frame: Up to 24 hours after surgery

    Presence of postoperative nausea or vomiting, recorded as a binary outcome of yes or no.

  3. Time to Achieve an Aldrete Score of at Least 8

    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.

  4. Time to Post-Anesthesia Care Unit Discharge Readiness

    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.

  5. Desflurane-Related Cost

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Magdalena Estefo, MD

CONTACT

[email protected]

+56 9 7986 5505

Sponsors and collaborators

Lead sponsor

Clínica Dávila

Other

Registry information

Official study title

Desflurane Versus Sevoflurane-Desflurane Swap in Adults Undergoing Bariatric Surgery: A Randomized Non-Inferiority Trial on Extubation Time

Acronym: SWAP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

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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