Effects of Direct Laryngoscopic and Fiberoptic Intubation on Intraocular Pressure

Not Applicable

Completed

• Conditions: Intubation Complication; Intraocular Pressure
• Interventions: Other: Direct laryngoscope; Other: Fiberoptic bronchoscope

• Registration Number: NCT03003585
• Lead Sponsor: Inonu University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2016-12-27
• Study First Posted: 2016-12-28
• Primary Completion: 2017-02
• Status Verified: 2017-04
• Study Completion: 2017-04-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct laryngoscopy	Direct laryngoscope	Evaluate the difference between the two groups about hemodynamic and intraocular pressure responses.
Fiberoptic bronchoscopy	Fiberoptic bronchoscope	Evaluate the difference between the two groups about hemodynamic and intraocular pressure responses.

Primary Outcome Measures

Name	Time	Method
Heart rate	From Beginning of Anesthesia induction to 5th minutes of intubation
Intraocular pressure	From Beginning of Anesthesia induction to 5th minutes of intubation
Systolic blood pressure	From Beginning of Anesthesia induction to 5th minutes of intubation
Adverse events	within the first 24 hour after surgery