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

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

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
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Completed
Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

April 2, 2026

Last Update Submit

July 31, 2026

Conditions

Intracranial PressureLaparoscopic SurgeryOptic Nerve Sheath Diameter

Keywords

SevofluraneDesfluraneTrendelenburg Position

Outcome Measures

Primary Outcomes (1)

  • Optic Nerve Sheath Diameter (ONSD)

    ONSD measured by transorbital ultrasound with a 7.5-15 MHz linear probe, 3.0 mm behind the posterior globe wall, between the outer edges of the dural sheath. At least three measurements are obtained from each eye and averaged.

    T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine

Secondary Outcomes (8)

  • Mean Arterial Pressure (MAP)

    T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine

  • Peripheral Oxygen Saturation (SpO2)

    T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine

  • End-tidal Carbon Dioxide (EtCO2)

    T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine

  • Arterial pH

    T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine

  • Partial Pressure of Carbon Dioxide (pCO2)

    T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine

  • +3 more secondary outcomes

Study Arms (2)

Group 1 (Sevo)

ACTIVE COMPARATOR

Anaesthesia maintenance with sevoflurane titrated to 1.0 MAC in 40% oxygen / 60% air.

Drug: Sevoflurane

Group 2 (Des)

ACTIVE COMPARATOR

Anaesthesia maintenance with desflurane titrated to 1.0 MAC in 40% oxygen / 60% air.

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.
  • ASA physical status I-II

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.
  • History of allergy to the study drugs
  • Known or suspected pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

SevofluraneDesflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Officials

  • Burak Ömür

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
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

July 5, 2026

Study Completion

July 15, 2026

Last Updated

August 4, 2026

Record last verified: 2026-07

Locations

TU(1)