Anesthesia on Optic Nerve Sheath Diameter

Not Applicable

Completed

• Conditions: Optic Nerve Sheath Diameter

• Registration Number: NCT04407715
• Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-04-30
• Primary Completion: 2019-10-30
• Study Completion: 2019-12-30
• Study First Submitted: 2020-03-10
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-26
• Last Update Submitted: 2020-05-26
• Study First Posted: 2020-05-29
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Optic Nerve Sheath Diamater	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 Outcome Measures

Name	Time	Method
Peroperative Complications	2 hours operation time	Complications during the surgery (decreased oxygen levels, hypercapnia, hypotension, hypertension, bradycardia, tachycardia, rhythm disorders) were recorded.
Postoperative Complications	postop 20 minutes	Complications in the recovery room (respiratory distress, decreased oxygen levels, hypotension, hypertension, bradycardia, tachycardia, vomiting, rhythm disorders) were recorded.

Trial Locations

Locations (1)

University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital; 🇹🇷 Bursa, Turkey