Effects of Direct Laryngoscopic and Fiberoptic Intubation on Intraocular Pressure

NCT ID: NCT03003585

Last Updated: 2017-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-04-04

Brief Summary

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In this study, the investigators aimed to compare the effects of direct laryngoscopic and fiberoptic endotracheal intubation on intraocular pressure.

Detailed Description

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Material and Method: Total of 54 American Society of Anesthesiologist Grade 1-2, Mallampati score 1 or 2, age between 18 to 65 patient planned to undergo nonopthalmic surgery will be included to study. Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary diseases, American Society of Anesthesiologist Grade III and IV, body mass index more than 35, difficult intubation, undergo obstetrical surgery and propofol, fentanyl, rocuronium contraindicated will be excluded from the study. Patients will be divided randomly into 2 groups as direct laryngoscopic and fiberoptic intubation group. Patients will be preoxygenated with %100 O2 for 3 minutes then anesthesia will be induced using propofol 2 mg / kg, fentanyl 1 mcg/kg, and rocuronium 0,5 mg / kg in both groups. After 3 minutes mask ventilation, patients will be intubated (women with No:7-7,5, men with No:8-8,5 intubation tube). Systolic blood pressure, diastolic blood pressure, mean arterial pressure, peripheral oxygen saturation,perfusion index will be recorded and intraocular pressure measured by ophthalmologist by tonopen device will be recorded pre-induction (basal), after induction, 1,2,3,5 minutes after intubation, respectively. Period between handling of laryngoscope or fiberoptic device after termination of mask ventilation and obtain end tidal CO2 will be accepted as application time and recorded. Study will be terminated after 5th minute values taken.

Conditions

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Intraocular Pressure Intubation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Fiberoptic bronchoscopy

Evaluate the difference between the two groups about hemodynamic and intraocular pressure responses.

Group Type ACTIVE_COMPARATOR

Fiberoptic bronchoscope

Intervention Type OTHER

This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.

Direct laryngoscopy

Evaluate the difference between the two groups about hemodynamic and intraocular pressure responses.

Group Type ACTIVE_COMPARATOR

Direct laryngoscope

Intervention Type OTHER

This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.

Interventions

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Direct laryngoscope

This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.

Intervention Type OTHER

Fiberoptic bronchoscope

This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ASA (American Society of Anesthesiologist) Grade 1-2,
* Mallampati score 1 or 2,
* Age between 18 to 65
* Patient planned to undergo nonopthalmic surgery.

Exclusion Criteria

* Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary diseases, ASA Grade III and IV, BMI more than 35,
* Patients with difficult intubation,
* Patients undergoing obstetrical surgery and propofol, fentanyl, rocuronium contraindicated.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Selim Ozkan

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Asozkan-2

Identifier Type: -

Identifier Source: org_study_id

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