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Clinical Trials/NCT04413903
NCT04413903
Completed
Not Applicable

The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations

Bursa Yüksek İhtisas Education and Research Hospital1 site in 1 country60 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mechanical Ventilation
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Enrollment
60
Locations
1
Primary Endpoint
Optic nerve sheath diameter (milimeter)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
October 31, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Umran Karaca

Principle İnvestigator

Bursa Yüksek İhtisas Education and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Optic nerve sheath diameter (milimeter)

Time Frame: 2 hours operation time

Optic nerve sheath diameter; It was measured from the optic nerve sheath 3 mm behind the optic disc from the closed upper eyelid. T0: Awake, T1: 5th minute after induction, T2: Gas insufflation start in supine position, T3: Maximum gas pressure is reached in reverse trendelenburg position, T4: Before extubation in supine position. 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 cmH2O .

Cognitive Function

Time Frame: 3 months after surgery

Cognitive function test with Mini Mental Conditioning Scale was performed to the patients before the anesthesia induction and 3 months after the surgery . Mini Mental Scale points are between 0 and 30.

Secondary Outcomes

  • Peroperative Complications(2 hours operation time)

Study Sites (1)

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