Clinical trial NCT04413903: the Effect of Different Mechanical Ventilation Modes on Optic Nerve Diameter and Conscious Functions
Official title: The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Keywords: Optic Nerve Sheath Diameter,
Minimental test
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-04
Enrollment: 60
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: ASA I-II 60 patients aged 18-65 years undergoing laparoscopic cholecystectomy surgery according to mechanical ventilator mode; Group P (n: 30) Pressure controlled ventilation was randomly divided into Group V (n: 30) volume controlled 50% air, PEEP 5 to 8ml / kg tidal volume.
Primary purpose: DIAGNOSTIC

Brief summary: During surgery, researchers use different methods in respiratory equipment. In the study researchers examine the effects of these methods on intraocular pressure changes by looking at the intraocular nerve diameter. Then look at the effects of these effects on patients conscious functions by asking some questions.

Detailed description: According to the mechanical ventilator application to be applied to the patients; Group P (n: 30) pressure controlled ventilation (PCV), Group V (n: 30) volume controlled ventilation (VCV) are randomly assigned to two groups. General anesthesia will be applied to all patients. Mechanical ventilation settings will be able to 8ml / kg TV (tidal volume). Demographic data (age, gender, weight, height) of patients, duration of surgery and peroperative complications will be recorded choosen time intervals.T0: awake, T1: 5th min after induction, T2: Gas insufflation start in supine position, T3: Maximum gas pressure is reached in reverse trendelenburg position, T4:Before extubation. SAB, DAB, OAB, KAH, SpO2, Ppeek, PEEP, EtCO2, optic nerve diameter will be recorded at same times. Cognitive function test will be performed at postoperative 24th hour for comparing the first awaken routin MMDT (Mini Mental Status Detection) scale. The same test will be repeated for patients who are called for routine general surgery outpatient control 3 months after surgery.

Eligibility criteria: Inclusion Criteria:

* ASA I-II
* 18-65 years old

Exclusion Criteria:

* Unable to cooperate
* Presence of eye disease (detachment, retinapathy, glaucoma)
* Presence of a previous eye operation
* Those with symptoms of KIBAS (intracranial pressure increase syndrome) (Intracranial lesion, previous cerebrovascular diseases)
* BMI (body mass index\> 40 kg / m2
* Obstructive and restrictive lung disease
* Pulmonary Hypertension
* Congestive Heart Failure

Primary outcomes:
measure: Optic nerve sheath diameter (milimeter)
timeFrame: 2 hours operation time
measure: Cognitive Function
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Peroperative Complications
timeFrame: 2 hours operation time
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital
Study officials:
affiliation: BYIEAH
name: Tugba Onur, MD
role: STUDY_CHAIR
affiliation: BYIEAH
name: Korgun Okmen, MD
role: STUDY_CHAIR
affiliation: BYIEAH
name: Serkan Terkancıoglu, MD
role: STUDY_CHAIR
affiliation: BYIEAH
name: Gorkem Cevik, MD
role: STUDY_CHAIR
References:
citation: Karaca U, Onur T, Okmen K, Terkanlioglu S, Cevik G, Ata F. Effect of Various Modes of Mechanical Ventilation in Laparoscopic Cholecystectomies on Optic Nerve Sheath Diameter and Cognitive Functions. J Laparoendosc Adv Surg Tech A. 2021 Jul;31(7):808-813. doi: 10.1089/lap.2020.0866. Epub 2020 Dec 11.