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Completed

NCT Number: NCT03003585

Effects of Direct Laryngoscopic and Fiberoptic Intubation on Intraocular Pressure

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Direct laryngoscope

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.

Fiberoptic bronchoscope

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.

Primary outcomes

  1. Systolic blood pressure

    Time frame: From Beginning of Anesthesia induction to 5th minutes of intubation

  2. Heart rate

    Time frame: From Beginning of Anesthesia induction to 5th minutes of intubation

  3. Adverse events

    Time frame: within the first 24 hour after surgery

  4. Intraocular pressure

    Time frame: From Beginning of Anesthesia induction to 5th minutes of intubation

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 28, 2016
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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