NCT07748247

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_4 obesity

Timeline
8mo left

Started Aug 2026

Shorter than P25 for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Aug 2026Apr 2027

First Submitted

Initial submission to the registry

July 24, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

August 3, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

August 5, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

July 24, 2026

Last Update Submit

August 3, 2026

Conditions

Keywords

DesfluraneSevofluraneGeneral AnesthesiaBariatric SurgeryExtubation TimeObesityLaparoscopic Gastric BypassRandomized TrialNon-Inferiority TrialPatient State Index

Outcome Measures

Primary Outcomes (1)

  • Extubation Time

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

    Perioperative

Secondary Outcomes (5)

  • Time to Achieve Patient State Index Greater Than 80

    Perioperative

  • Postoperative Nausea and Vomiting

    Up to 24 hours after surgery

  • Time to Achieve an Aldrete Score of at Least 8

    Up to 24 hours after surgery

  • Time to Post-Anesthesia Care Unit Discharge Readiness

    Up to 24 hours after surgery

  • Desflurane-Related Cost

    Periprocedural (during surgery)

Study Arms (2)

Continuous Desflurane

EXPERIMENTAL

Participants receive desflurane as the inhalational anesthetic throughout the entire elective laparoscopic bariatric surgery according to the study protocol.

Drug: Desflurane

Sevoflurane-Desflurane Swap

EXPERIMENTAL

Participants receive sevoflurane during most of the procedure and are switched to desflurane 30 minutes before the end of surgery according to the study protocol.

Drug: Sevoflurane-Desflurane

Interventions

Desflurane administered as the inhalational anesthetic throughout the surgical procedure.

Continuous Desflurane

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

Sevoflurane-Desflurane Swap

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Dávila

Santiago, Santiago Metropolitan, 8431657, Chile

Location

MeSH Terms

Conditions

Obesity

Interventions

Desflurane

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Central Study Contacts

Magdalena Estefo, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2026

First Posted

August 5, 2026

Study Start

August 3, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

August 5, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available because the study involves clinical data collected at a single institution, and no data-sharing agreement or repository has been established. Only aggregate study results will be reported in scientific publications and presentations.

Locations