Clinical trial NCT05763056: Effects of Intubation on Intra-ocular Pressure and Optic Nerve Sheath Diameter
Official title: Comparison of the Effects of Intubation With a Machintosh Laryngoscope, McGrath Videolaryngoscope and C-Mac Videolaryngoscope on Intra-ocular Pressure, Optic Nerve Sheath Diameter and Haemodynamic Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Keywords: laryngoscope
intraocular pressure
optic nerve sheath
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Prospective Randomized, Placebo-Controlled Clinical Trial
Primary purpose: PREVENTION

Brief summary: Brief Summary:

In this study, the investigators aimed to compare the effects of different types of endotracheal instruments (Machintosh laryngoscope, McGrath videoingoscope and C-Mac videoryngoscope) on intraocular pressure, optic nerve diameter and hemodynamic parameters.

Detailed description: Detailed Description:

Laryngoscopy and endotracheal intubation cause increased intracranial pressure due to hypoxia, hypercapnia, straining, or coughing. It may be an indirect result of increased arterial and venous pressure, as well as a direct effect of intubation.

With the emergence of neuroimaging techniques and new diagnostic tools, various methods have been developed that can replace invasive methods, which are the gold standard in intraocular pressure measurement. However, invasive methods such as intraventricular and intraparenchymal catheter systems have some disadvantages and are associated with significant risks in terms of infection, bleeding, and time lost until follow-up.

The intraorbital subarachnoid space surrounding the optic nerve shows the same pressure variation as the intracranial subarachnoid space, and any increase in intracranial pressure is also seen in the orbital subarachnoid space. With the increase in intracranial pressure, the optic nerve, optic nerve sheath diameter, and subarachnoid space enlarge. There are many studies reporting that optic nerve sheath diameter can be evaluated using ultrasonography. Although there is no clear cut-off value for optic nerve sheath diameter, previous studies have found that an optic nerve sheath diameter of 5.0 mm and above may indicate an increase in intracranial pressure.

Previous studies have determined that the distribution of intraocular pressure in the adult population varies between 11 mmHg and 21 mmHg, and the mean intraocular pressure is 16.5 mmHg. It is well known that the sympathoadrenergic response caused by laryngoscopy and tracheal intubation significantly increases intraocular pressure (at least 10-20 mmHg). In addition, intravenous pressure and intraocular pressure increase due to cough, airway obstruction, succinylcholine use, hypoxia and hypercapnia during intubation.

In this study, the investigators aimed to compare the effects of different types of endotracheal instruments (Machintosh laryngoscope, McGrath videoingoscope and C-Mac videoringoscope) on intraocular pressure, optic nerve sheath diameter and hemodynamic parameters.

Eligibility criteria: Inclusion Criteria:

* Non-ophthalmic surgery
* Mallampati I or II classifications
* American Society of Anesthesiologists (ASA) I-II

Exclusion Criteria:

* Glaucoma,
* Diabetes mellitus,
* Cardiovascular diseases,
* Pulmonary diseases,
* ASA 3 and 4
* Body Mass Index (BMI) greater than 30
* Eye surgery
* Difficult intubation (Mallampati score of 3 or 4, thyromental distance of less than 6 cm and a maximum mouth opening of less than 3 cm)
* Intraocular pressure value more than 20 mmHg
* More than two intubation attempts
* A risk of regurgitation patients
* History of obstetric surgery
* Allergies to propofol, fentanyl or rocuronium

Primary outcomes:
measure: Intraocular pressure-1
timeFrame: Intraocular pressure will be measured at before induction
measure: Intraocular pressure-2
timeFrame: Intraocular pressure will be measured at just before laryngoscopy and intubation
measure: Intraocular pressure-3
timeFrame: Intraocular pressure will be measured at immediately after intubation
measure: Intraocular pressure-4
timeFrame: Intraocular pressure will be measured at 5 minutes after intubation
measure: Intraocular pressure-5
timeFrame: Intraocular pressure will be measured at 10 minutes after intubation
Secondary outcomes:
measure: Optic nerve diameter measurement-1
timeFrame: Optic nerve diameter measurement-1 will be measured at before induction
measure: Optic nerve diameter measurement-2
timeFrame: Optic nerve diameter measurement-2 will be measured at just before laryngoscopy and intubation
measure: Optic nerve diameter measurement-3
timeFrame: Optic nerve diameter measurement-3 will be measured at immediately after intubation
measure: Optic nerve diameter measurement-4
timeFrame: Optic nerve diameter measurement-4 will be measured at 5 minutes after intubation
measure: Optic nerve diameter measurement-5
timeFrame: Optic nerve diameter measurement-5 will be measured at 10 minutes after intubation
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty
Study officials:
affiliation: Inonu University Medical Faculty , malatya.turkey
name: Erol Karaaslan, assoc prof
role: STUDY_DIRECTOR
References:
citation: Dubourg J, Javouhey E, Geeraerts T, Messerer M, Kassai B. Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2011 Jul;37(7):1059-68. doi: 10.1007/s00134-011-2224-2. Epub 2011 Apr 20.