Anesthesia on Optic Nerve Sheath Diameter

Overview

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.

Full Title of Study: “The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diameter in Laparotomic Gynecological Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 30, 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Peroperative Complications
    • Time Frame: 2 hours operation time
    • Complications during the surgery (decreased oxygen levels, hypercapnia, hypotension, hypertension, bradycardia, tachycardia, rhythm disorders) were recorded.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bursa Yüksek İhtisas Education and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anıl Onur, Principle İnvestigator – Bursa Yüksek İhtisas Education and Research Hospital
  • Overall Official(s)
    • Anıl Onur, MD, Principal Investigator, University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
    • H.Erkan Sayan, MD, Study Director, University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
    • Tugba Onur, MD, Study Chair, University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
    • Umran Karaca, MD, Study Chair, University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
    • Canan Yılmaz, MD, Study Chair, University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital

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