Anesthesia on Optic Nerve Sheath Diameter

NCT ID: NCT04407715

Last Updated: 2020-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2019-12-30

Brief Summary

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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

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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.

Conditions

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Optic Nerve Sheath Diameter

Keywords

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Minimal Flow Anesthesia Optic Nerve Sheath Diameter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Anıl Onur

Principle İnvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anıl Onur, MD

Role: PRINCIPAL_INVESTIGATOR

University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital

H.Erkan Sayan, MD

Role: STUDY_DIRECTOR

University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital

Tugba Onur, MD

Role: STUDY_CHAIR

University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital

Umran Karaca, MD

Role: STUDY_CHAIR

University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital

Canan Yılmaz, MD

Role: STUDY_CHAIR

University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital

Locations

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University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2018/11-0

Identifier Type: -

Identifier Source: org_study_id