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Anesthesia on Optic Nerve Sheath Diameter

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ClinicalTrials.gov Identifier: NCT04407715
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Anıl Onur, 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.

Condition or disease Intervention/treatment Phase
Optic Nerve Sheath Diameter Procedure: The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model 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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diameter in Laparotomic Gynecological Surgery
Actual Study Start Date : April 30, 2019
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : December 30, 2019

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407715


Locations
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Turkey
University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital
Bursa, Turkey
Sponsors and Collaborators
Bursa Yüksek İhtisas Education and Research Hospital
Investigators
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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
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Responsible Party: Anıl Onur, Principle İnvestigator, Bursa Yüksek İhtisas Education and Research Hospital
ClinicalTrials.gov Identifier: NCT04407715    
Other Study ID Numbers: 2018/11-0
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anıl Onur, Bursa Yüksek İhtisas Education and Research Hospital:
Minimal Flow Anesthesia
Optic Nerve Sheath Diameter
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs