Anesthesia on Optic Nerve Sheath Diameter

NCT04407715 | Completed

• 1 other identifier: 2018/11-0
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Optic Nerve Sheath Diameter

Keywords

Minimal Flow Anesthesia; Optic Nerve Sheath Diameter

Outcome Measures

Primary Outcomes (1)

• Optic Nerve Sheath Diamater

  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

  2 hours operation time

Secondary Outcomes (2)

• Peroperative Complications

  2 hours operation time

• Postoperative Complications

  postop 20 minutes

Study Arms (2)

High Flow Anesthesia, Low Flow Anesthesia

PLACEBO COMPARATOR

. 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. Group 1 (n = 40) was operated under high flow anesthesia with 50% O2 - 50% air at 2 L/min and desflurane at 1.1 MAC for the duration of the surgery. For anesthesia maintenance, Group 2 (n=40) was administered 50% oxygen - 50% air at 2 L/min and desflurane for 10-15 minutes. After reaching 1.1 MAC, it was switched to minimal flow with 50-60% oxygen- 40-50% air at 0.5 L/min and desflurane. 10 minutes before the end of the surgery, it was switched to high flow with 50% oxygen -50% air at 2 L/min.

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

Peroperetive Optic Nerve Sheath Diameter

ACTIVE COMPARATOR

Optic nerve sheath diameter measurements were performed by an experienced and the same anesthetist. In the measurements, the GE Healthcare Logiq e series USG device and 12-MHz linear probe were used. Longitudinal and transverse axis images were obtained on both eyelids while the patient was in the supine position. Measurements were taken 3 mm behind the optic nerve head

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

Interventions

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.

High Flow Anesthesia, Low Flow Anesthesia; Peroperetive Optic Nerve Sheath Diameter

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location

Study Officials

• Anıl Onur, MD

  University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• H.Erkan Sayan, MD

  University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital

  STUDY DIRECTOR

• Tugba Onur, MD

  University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Umran Karaca, MD

  University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Canan Yılmaz, MD

  University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle İnvestigator

Model Details: 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 Record Dates

• First Submitted: March 10, 2020
• First Posted: May 29, 2020
• Study Start: April 30, 2019
• Primary Completion: October 30, 2019
• Study Completion: December 30, 2019
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)