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NCT Number: NCT07525648

Comparison of the Effects of Sevoflurane and Desflurane on Optic Nerve Sheath Diameter During Laparoscopic Surgery

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.

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Key information

Conditions

Intracranial Pressure Laparoscopic Surgery Optic Nerve Sheath Diameter

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

About this study

The primary objective of this study is to compare the ONSD values measured by ultrasound between the sevoflurane and desflurane groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients planned for laparoscopic hysterectomy bilateral oophorectomy surgery under general anesthesia.
  • ASA physical status I-II

Exclusion criteria

  • 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

Treatment and study plan

Sevoflurane

Drug

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

Desflurane

Drug

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

Primary outcomes

  1. Optic Nerve Sheath Diameter (ONSD)

    Time frame: 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

    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.

Secondary outcomes

  1. Mean Arterial Pressure (MAP)

    Time frame: 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

    Mean arterial pressure will be measured via non-invasive blood pressure monitoring or invasive radial artery cannulation.

  2. Peripheral Oxygen Saturation (SpO2)

    Time frame: 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

    Oxygen saturation will be monitored continuously using pulse oximetry.

  3. End-tidal Carbon Dioxide (EtCO2)

    Time frame: 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 levels will be measured using capnography monitoring.

  4. Arterial pH

    Time frame: 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 levels will be evaluated from arterial blood gas analysis samples.

  5. Partial Pressure of Carbon Dioxide (pCO2)

    Time frame: 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

    pCO2 levels will be evaluated from arterial blood gas analysis samples.

  6. Change in optic nerve sheath diameter between consecutive study phases (Δ ONSD)

    Time frame: 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

    Within-patient change in ONSD between consecutive time points (Δ T1-T2, Δ T2-T3, Δ T3-T4, Δ T4-T5) and across the whole procedure (Δ T1-T4, Δ T1-T5), compared between the sevoflurane and desflurane groups.

  7. Arterial lactate

    Time frame: 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 lactate measured from arterial blood gas samples.

  8. Peak airway pressure

    Time frame: 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

    Peak inspiratory airway pressure recorded from the anaesthesia ventilator.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Comparison of the Effects of Sevoflurane and Desflurane Used for Anesthesia Maintenance on Optic Nerve Sheath Diameter in the Trendelenburg Position

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Aug 4, 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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