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NCT Number: NCT04407715

Anesthesia on Optic Nerve Sheath Diameter

Different amounts of anesthetic gas can be used in the obstetric gynecological surgery operations to be performed with open method. Researchers aimed to compare the effect of gas changes on intraocular nerve diameter by ultrasonography.

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Key information

Conditions

Optic Nerve Sheath Diameter

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

About this study

A total of 80 patients who underwent laparotomic gynecological surgery were divided into two groups prospectively: high flow of 2 L/min and minimal flow of 0.5 L/min. Anesthesia was maintained with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 1 (n=40) and with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 2 (n=40). After 10-15 minutes, group 2 was administered minimal flow with 50-60% oxygen-40-50% air at 0.5 L/min and desflurane, and 10 minutes before the end of the surgery, the patients were switched to high flow with 50% oxygen-50% air at 2 L/min.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18-65 years
  • ASA I-II
  • Who underwent laparotomic gynecological surgery

Exclusion criteria

  • Patients with obstructive pulmonary disease
  • Patients with decompensated diabetes, those with a fasting period of more than 12 hours -Acute alcohol intoxication
  • Chronic alcohol use
  • Who refuse to participate in the study
  • Who are not cooperative, do not speak Turkish
  • Who had known eye disease (glaucoma, retinal detachment), had a previous history of eye surgery,
  • Increased intracranial pressure findings (intracranial lesion, previous cerebrovascular diseases
  • Body mass index of > 40kg/m2
  • ASA > III

Treatment and study plan

The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater

Procedure

The patients were randomly allocated to one of the two groups of fresh gas flows using the closed-envelope technique: 2 L/min high flow and 0.5 L/min minimal flow.

Primary outcomes

  1. Optic Nerve Sheath Diamater

    Time frame: 2 hours operation time

    Optic nerve sheath diamater measurements of the patients were recorded before and during the surgery at specified time points (T0: awake, T1: High fresh gas flow after induction at the 10th min., T2: Inhalation anesthesia at the 30th min., T3: Inhalation anesthesia at the 60th min., T4: Inhalation anesthesia at the 90th min., T5: Before extubation).A typical optic nerve sheath is generally less than 5 mm in diameter, and diameters greater than 5.5 mm predict an ICP of ≥20 cm H2O with 100% sensitivity and specifity

Secondary outcomes

  1. Peroperative Complications

    Time frame: 2 hours operation time

    Complications during the surgery (decreased oxygen levels, hypercapnia, hypotension, hypertension, bradycardia, tachycardia, rhythm disorders) were recorded.

  2. Postoperative Complications

    Time frame: postop 20 minutes

    Complications in the recovery room (respiratory distress, decreased oxygen levels, hypotension, hypertension, bradycardia, tachycardia, vomiting, rhythm disorders) were recorded.

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diameter in Laparotomic Gynecological Surgery

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 29, 2020
Registry last updated
Mar 3, 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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