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the Effect of Different Mechanical Ventilation Modes on Optic Nerve Diameter and Conscious Functions

B

Bursa Yüksek İhtisas Education and Research Hospital

Status

Completed

Conditions

Mechanical Ventilation

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04413903
2017-17/23

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Pressure controlled ventilation, Volum controlled ventilation
Active Comparator group
Description:
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 ventilation settings were adjusted to be 50% O2- 50% air, 8ml / kg TV (tidal volume) and PEEP 5.
Treatment:
Procedure: The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations
Optic Nerve Sheath Diameter
Active Comparator group
Description:
In optic nerve diameter measurements; A layer of water-soluble sterile gel was applied to the closed upper eyelid. The linear 10-5 MHz ultrasound probe was carefully placed on the upper eyelid over the gel. The entrance of the optic nerve to the orbital globe in 2D mode was displayed on the monitor without applying too much pressure. After finding the optimal contrast between the retrobulbar echogenic fat tissue and vertical hypoechoic band 23, the diameter of the optic nerve sheath was measured 3 mm behind the optic disc using an electronic caliper.
Treatment:
Procedure: The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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