Effects of Direct Laryngoscopic and Fiberoptic Intubation on Intraocular Pressure

Comparison of Effects of Direct Laryngoscopic and Fiberoptic Oral Endotracheal Intubation on Intraocular Pressure

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

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure; Intubation Complication
• Intervention / Treatment: Other: Fiberoptic bronchoscope; Other: Direct laryngoscope

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fiberoptic bronchoscopy; Evaluate the difference between the two groups about hemodynamic and intraocular pressure responses.	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.
Active Comparator: Direct laryngoscopy; Evaluate the difference between the two groups about hemodynamic and intraocular pressure responses.	Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Inonu University

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): April 4, 2017

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: December 27, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: intraocular pressure; direct laryngoscopy; fiberoptic bronchoscopy
• Other Study ID Numbers: Asozkan-2