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

Influence of Endotracheal Intubation versus Endotracheal Intubation with Lidocaine on Intracranial Pressure assessed by Optic Nerve Sheath Diameter

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000704-26-NL

Enrollment

Registered

2018-03-06

Start date

2018-08-10

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing surgery at the Erasmus Medical Centre Rotterdam in a period from January 2018 till the end of inclusion.

Interventions

Trade Name: Lidocaïne HCL Product Name: Lidocaine HCL Product Code: Lidocaine HCL Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: LIDOCAINE HYDROCHLORIDE Ot

Eligibility

Sex/Gender

All

Inclusion criteria

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

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. o Heart block, second or third degree (without pacemaker) o Severe sinoatrial block (without pacemaker) o Serious adverse drug reaction to lidocaine or amide local anesthetics o Concurrent treatment with quinidine, flecainide, disopyramide, procainamide (class I antiarrhythmic agents) o Prior use of amiodarone hydrochloride o Adams-Stokes syndrome (ASS) o Wolff-Parkinson-White syndrome (WPW) o Severe heart failure

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): Time taken for the ONSD to return back to its initial value once the patients is intubated ;Timepoint(s) of evaluation of this end point: after intubation	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026