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Completed

NCT Number: NCT04413903

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

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.

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Key information

Conditions

Mechanical Ventilation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

Bursa, 60160, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. 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 .

  2. 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

  1. Peroperative Complications

    Time frame: 2 hours operation time

    Complications during the surgery (hypercapnia, hypotension,hypertension,rythm disorder) were recorded.

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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