- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07525648
Comparison of the Effects of Sevoflurane and Desflurane on Optic Nerve Sheath Diameter During Laparoscopic Surgery
Comparison of the Effects of Sevoflurane and Desflurane Used for Anesthesia Maintenance on Optic Nerve Sheath Diameter in the Trendelenburg Position
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
The primary objective of this study is to compare the ONSD values measured by ultrasound between the sevoflurane and desflurane groups.
The secondary objective is to evaluate the relationship between ONSD changes, hemodynamic parameters, and postoperative neurological complications.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Istanbul Medipol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients planned for laparoscopic hysterectomy bilateral oophorectomy surgery under general anesthesia.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1 (Sevo)
|
Anesthesia maintenance will be provided with sevoflurane at 1 MAC in a 40% oxygen-air mixture.
|
|
Active Comparator: Group 2 (Des)
|
Anesthesia maintenance will be provided with desflurane at 1 MAC in a 40% oxygen-air mixture.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Optic Nerve Sheath Diameter (ONSD)
Time Frame: Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position."
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Arterial Pressure (MAP)
Time Frame: Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position."
|
Mean arterial pressure will be measured via non-invasive blood pressure monitoring or invasive radial artery cannulation.
|
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)
Time Frame: 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 will be continuously monitored and recorded using electrocardiography (ECG).
|
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)
Time Frame: Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position."
|
Oxygen saturation will be monitored continuously using pulse oximetry.
|
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)
Time Frame: 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 levels will be measured using capnography monitoring.
|
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
Time Frame: 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 levels will be evaluated from arterial blood gas analysis samples.
|
Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position."
|
|
Partial Pressure of Carbon Dioxide (pCO2)
Time Frame: Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position."
|
pCO2 levels will be evaluated from arterial blood gas analysis samples.
|
Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position."
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 191 - 2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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