Anesthesia on Optic Nerve Sheath Diameter

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

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.

Study Overview

• Status: Completed
• Conditions: Optic Nerve Sheath Diameter
• Intervention / Treatment: Procedure: The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey
    • University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: High Flow Anesthesia, Low Flow Anesthesia; . 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; 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.
ACTIVE_COMPARATOR: Peroperetive Optic Nerve Sheath Diameter; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Principal Investigator: Anıl Onur, MD, University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital; Study Director: H.Erkan Sayan, MD, University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital; Study Chair: 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 record dates

Study Major Dates

• Study Start (ACTUAL): April 30, 2019
• Primary Completion (ACTUAL): October 30, 2019
• Study Completion (ACTUAL): December 30, 2019

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (ACTUAL): May 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Optic Nerve Sheath Diameter; Minimal Flow Anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2018/11-0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No