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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03003585
Other study ID # Asozkan-2
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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