NCT07295158

Brief Summary

This single-center, prospective, randomized, assessor-blinded clinical trial aims to compare the effects of sevoflurane and desflurane anesthesia on intraoperative mechanical power in adult patients undergoing elective laparoscopic cholecystectomy. Mechanical power will be measured at three standardized time points using a validated formula, and secondary outcomes include driving pressure values and early postoperative respiratory complications (desaturation, laryngospasm, bronchospasm, cough).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Mar 2026May 2026

First Submitted

Initial submission to the registry

December 8, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 9, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

December 8, 2025

Last Update Submit

March 12, 2026

Conditions

Perioperative Respiratory Mechanics

Outcome Measures

Primary Outcomes (1)

  • Mechanical Power (MP) during General Anesthesia

    Measured at three intraoperative time points: Post-intubation baseline (MP1) 15 minutes after pneumoperitoneum (MP2) End of surgery before emergence (MP3)

Study Arms (2)

Arm S- Sevoflurane Group

EXPERIMENTAL

Maintenance of general anesthesia with sevoflurane 2% during laparoscopic cholecystectomy. Mechanical power is measured at three intraoperative time points using standardized ventilator settings.

Drug: Sevoflurane

Arm D-desflurane group

EXPERIMENTAL

Maintenance of general anesthesia with desflurane 6% during laparoscopic cholecystectomy. Mechanical power is measured at three standardized intraoperative time points under identical ventilator settings.

Drug: Desflurane

Interventions

SevofluraneDRUG

General anesthesia will be maintained with sevoflurane at 2% concentration in patients assigned to the Sevoflurane Group (Group S). Standardized ventilator settings will be applied for all participants, and mechanical power will be measured at three intraoperative time points while sevoflurane is used as the sole maintenance inhalational agent.

Also known as: Group S
Arm S- Sevoflurane Group
DesfluraneDRUG

Maintenance of general anesthesia with desflurane 6% during laparoscopic cholecystectomy. Mechanical power is measured at three intraoperative time points using standardized ventilator settings.

Arm D-desflurane group

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18-65 years
  • ASA Physical Status I-II
  • Scheduled for elective laparoscopic cholecystectomy
  • Able to provide written informed consent

You may not qualify if:

  • Known hypersensitivity or contraindication to study medications (sevoflurane or desflurane)
  • Severe chronic obstructive pulmonary disease (COPD)
  • Uncontrolled bronchial asthma
  • Decompensated heart failure (NYHA Class III-IV)
  • History of prior lung surgery
  • Morbid obesity (BMI \> 35 kg/m²)
  • Pregnancy
  • Refusal to participate or inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, Konya, 42020, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Jo YY, Chang YJ, Lee D, Kim YB, Jung J, Kwak HJ. Comparisons of Mechanical Power and Respiratory Mechanics in Pressure-Controlled Ventilation and Volume-Controlled Ventilation during Laparoscopic Cholecystectomy in Elderly Patients. J Pers Med. 2023 Jan 23;13(2):201. doi: 10.3390/jpm13020201.

    PMID: 36836435BACKGROUND

MeSH Terms

Interventions

SevofluraneDesflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Central Study Contacts

Nuran AKINCI EKİNCİ

CONTACT

+905337637180nurandr@yahoo.com

Esma Karaarslan

CONTACT

+905057317061

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and postoperative outcome assessors are masked to group allocation. The anesthesia team administering sevoflurane or desflurane is not blinded, but all intraoperative data collectors and postoperative evaluators remain blinded to the inhalational agent used. Randomization is performed using sealed opaque envelopes to maintain allocation concealment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Anesthesiology and Reanimation

Study Record Dates

First Submitted

December 8, 2025

First Posted

December 19, 2025

Study Start

March 9, 2026

Primary Completion

April 30, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)