Effects of Direct Laryngoscopic and Fiberoptic Intubation on Intraocular Pressure

Intraocular Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003585
• Other study ID #: Asozkan-2
• Status: Completed
• Phase: N/A
• First received: December 22, 2016
• Last updated: April 4, 2017
• Start date: December 2016
• Est. completion date: April 4, 2017

Study information

• Verified date: April 2017
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 4, 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intraocular Pressure
• Intubation Complication

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure		From Beginning of Anesthesia induction to 5th minutes of intubation
Primary	Heart rate		From Beginning of Anesthesia induction to 5th minutes of intubation
Primary	Adverse events		within the first 24 hour after surgery
Primary	Intraocular pressure		From Beginning of Anesthesia induction to 5th minutes of intubation