Influence of Endotracheal Intubation versus Endotracheal Intubation with Lidocaine on Brain Pressure assessed by Optic Ultrasound

Phase 1

• Conditions: Patients undergoing surgery at the Erasmus Medical Centre Rotterdam in a period from January 2018 till the end of inclusion.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-000704-26-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-06
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients aged >18 year old, ASA I or II, scheduled for elective surgery under general anesthesia with a planned duration of the procedure > 30 min that can be routinely performed with a ETI.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Surgery of the eye an eye region
-Bilateral eye trauma
-Glaucoma
-Mentally retarded patients
-Contraindications for the use of lidocaine e.g.
oHeart block, second or third degree (without pacemaker)
oSevere sinoatrial block (without pacemaker)
oSerious adverse drug reaction to lidocaine or amide local anesthetics
oConcurrent treatment with quinidine, flecainide, disopyramide, procainamide (class I antiarrhythmic agents)
oPrior use of amiodarone hydrochloride
oAdams-Stokes syndrome (ASS)
oWolff-Parkinson-White syndrome (WPW)
oSevere heart failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect on the distention of the ONSD while using lidocaine 1,5 mg/kg IV during endotracheal intubation versus placebo. ;Secondary Objective: The secondary objective of this study is to investigate the effect size of lidocaine 1,5 mg/kg IV;Primary end point(s): Difference in optic nerve sheet diameter in millimetre before, during and after intubation between both groups.;Timepoint(s) of evaluation of this end point: before, during and after intubation between both groups.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time taken for the ONSD to return back to its initial value once the patients is<br>intubated<br>;Timepoint(s) of evaluation of this end point: after intubation