NCT07525648

Brief Summary

Laparoscopic surgeries require pneumoperitoneum and Trendelenburg position, which may lead to increased intracranial pressure (ICP). Optic nerve sheath diameter (ONSD) measurement via ultrasound is a non-invasive method to evaluate ICP. This prospective study aims to compare the effects of sevoflurane and desflurane on ONSD in patients undergoing laparoscopic hysterectomy and bilateral oophorectomy in the Trendelenburg position.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Apr 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

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Study Timeline

Key milestones and dates

Study Progress75%
Apr 2026May 2026

First Submitted

Initial submission to the registry

April 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2026

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

25 days

First QC Date

April 2, 2026

Last Update Submit

April 16, 2026

Conditions

Intracranial PressureLaparoscopic SurgeryOptic Nerve Sheath Diameter

Keywords

SevofluraneDesfluraneTrendelenburg Position

Outcome Measures

Primary Outcomes (1)

  • Optic Nerve Sheath Diameter (ONSD)

    Three measurements will be taken in the transverse and sagittal planes for each eye and the average will be calculated.

    Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position."

Secondary Outcomes (6)

  • Mean Arterial Pressure (MAP)

    Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position."

  • Heart Rate (HR)

    Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position."

  • Peripheral Oxygen Saturation (SpO2)

    Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position."

  • End-tidal Carbon Dioxide (EtCO2)

    Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position."

  • Arterial pH

    Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position."

  • +1 more secondary outcomes

Study Arms (2)

Group 1 (Sevo)

ACTIVE COMPARATOR
Drug: Sevoflurane

Group 2 (Des)

ACTIVE COMPARATOR
Drug: Desflurane

Interventions

SevofluraneDRUG

Anesthesia maintenance will be provided with sevoflurane at 1 MAC in a 40% oxygen-air mixture.

Group 1 (Sevo)
DesfluraneDRUG

Anesthesia maintenance will be provided with desflurane at 1 MAC in a 40% oxygen-air mixture.

Group 2 (Des)

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients planned for laparoscopic hysterectomy bilateral oophorectomy surgery under general anesthesia.

You may not qualify if:

  • Patients receiving beta-blocker or diuretic treatment.
  • Patients with severe heart failure.
  • Patients diagnosed with diabetes with ocular or neurological complications.
  • Patients who have undergone cardiac surgery, eye surgery, brain surgery, or thoracic surgery.
  • Patients with a history of hydrocephalus, glaucoma, intracranial mass, and stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

SevofluraneDesflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 13, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

May 10, 2026

Study Completion (Estimated)

May 15, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)