Clinical trial

Effect of Lidocaine Sprayed at the Laryngeal Inlet and Endotracheal Tube Cuff Versus Intravenous Lidocaine for Attenuating Hemodynamic Response During Laryngoscopy and Intubation in Neurosurgical Patients

Name

HE661362

Description

The goal of this clinical trial is to to evaluate the efficacy of lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff compare with intravenous lidocaine on the hemodynamic response to laryngoscopy and intubation in patients undergoing elective neurological procedures during general anesthesia with total intravenous technique. The main question it aims to answer is: - Does topical lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff have more effect on stabilizing hemodynamic responses to laryngoscopy and intubation than intravenous lidocaine, in neurosurgical patients who undergo general anesthesia with total intravenous technique? Participants will be recruited and randomized to receive either lidocaine spray (Group SL) or intravenous lidocaine (group IL) to blunt hemodynamic response to laryngoscopy and intubation.

Trial arms

Trial start

2024-01-01

Estimated PCD

2025-01-01

Trial end

2025-05-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

lidocaine spray

Group SL: Spray 10% lidocaine for 4 puffs at the endotracheal tube cuff, also prepare for spray at the laryngeal inlet for 4 puffs (total approximately 1.5mg/kg)

Arms:

Group SL

Other names:

10% lidocaine spray

Intravenous Lidocaine

2% lidocaine 1.5 mg/kg IV will be given 2 minutes after cisatracurium injection (3 minutes prior intubation).

Arms:

Group IL

Other names:

2%Intravenous Lidocaine

Size

Primary endpoint

Changing in mean arterial pressure (MAP) during the peri-intubation period

T0: Baseline at operating room, T1: immediately after cisatracurium injection, T2: During direct laryngoscopy, T3: During intubation, T4-T9: repeated measurement every 1 minute until 6 minute after intubation

Changing in blood pressure (BP) during the peri-intubation period

Changing in heart rate (HR) during the peri-intubation period

Eligibility criteria

Inclusion Criteria: 1. Age 18-65 years old 2. American Society of Anesthesiologists (ASA) physical status classification I-II Exclusion Criteria: 1. History of lidocaine allergy 2. Predicted difficult airways 3. Body mass index \> 35 kilograms per meter squared 4. Risk aspiration 5. Baseline hemodynamic instability; heart rate \< 50 bpm, heart rate \> 120 bpm, blood pressure \< 90/60 mmHg, blood pressure \> 160/90 mmHg 6. Underlying disease: epilepsy, cardiovascular disease, heart failure, impaired cardiac function, severe renal dysfunction, impaired hepatic function, peripheral vascular disease 7. Pregnancy 8. Cerebral aneurysm, Arteriovenous malformation, Tumor size \> 4 centimeters, Brain herniation

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. Group SL: 10%lidocaine spray total 8 puffs at laryngoscopes blade and endotracheal tube cuff.\n2. Group IL: 2% lidocaine intravenous 1.5 mg/kg, not exceed 80 mg equally to spray group.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2024-01-26

1 organization

1 product

5 indications

Organization

Khon Kaen University

Product

Lidocaine

Indication

Laryngoscopy

Indication

Endotracheal intubation

Indication

Hemodynamics

Indication

Neurosurgery

Indication

Lidocaine