Clinical trial NCT04407715: Anesthesia on Optic Nerve Sheath Diameter
Official title: The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diameter in Laparotomic Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optic Nerve Sheath Diameter
Keywords: Minimal Flow Anesthesia
Optic Nerve Sheath Diameter
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Optic Nerve Sheath Diamater
timeFrame: 2 hours operation time
Secondary outcomes:
measure: Peroperative Complications
timeFrame: 2 hours operation time
measure: Postoperative Complications
timeFrame: postop 20 minutes
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital
Study officials:
affiliation: University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
name: Anıl Onur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
name: H.Erkan Sayan, MD
role: STUDY_DIRECTOR
affiliation: University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
name: Tugba Onur, MD
role: STUDY_CHAIR
affiliation: University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
name: Umran Karaca, MD
role: STUDY_CHAIR
affiliation: University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
name: Canan Yılmaz, MD
role: STUDY_CHAIR
References: