Effect of Lidocaine Sprayed for Attenuating Hemodynamic Response During Laryngoscopy and Intubation

NCT06226532 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: HE661362
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laryngoscopy; Intubation; Hemodynamics; Neurosurgery; Lidocaine

Keywords

Lidocaine; Laryngoscopy and intubation; Hemodynamics; Neurosurgery

Outcome Measures

Primary Outcomes (3)

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

  Mean arterial pressure was recorded in mmHg by the anesthesiologist

  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

  Blood pressure was recorded in mmHg by the anesthesiologist

  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 heart rate (HR) during the peri-intubation period

  Heart rate was recorded in bpm by the anesthesiologist

  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

Secondary Outcomes (1)

• Incidence of adverse event during laryngoscopy and intubation procedure

  During laryngoscopy and intubation procedure

Study Arms (2)

Group SL

EXPERIMENTAL

10%lidocaine spray total 8 puffs at laryngoscopes blade and endotracheal tube cuff, 4 puffs each.

Drug: lidocaine spray

Group IL

ACTIVE COMPARATOR

2% lidocaine intravenous 1.5 mg/kg, not exceed 80 mg equally to spray group.

Drug: Intravenous Lidocaine

Interventions

lidocaine spray DRUG

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)

Also known as: 10% lidocaine spray

Group SL

Intravenous Lidocaine DRUG

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

Also known as: 2%Intravenous Lidocaine

Group IL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old
• American Society of Anesthesiologists (ASA) physical status classification I-II

You may not qualify if:

• History of lidocaine allergy
• Predicted difficult airways
• Body mass index \> 35 kilograms per meter squared
• Risk aspiration
• Baseline hemodynamic instability; heart rate \< 50 bpm, heart rate \> 120 bpm, blood pressure \< 90/60 mmHg, blood pressure \> 160/90 mmHg
• Underlying disease: epilepsy, cardiovascular disease, heart failure, impaired cardiac function, severe renal dysfunction, impaired hepatic function, peripheral vascular disease
• Pregnancy
• Cerebral aneurysm, Arteriovenous malformation, Tumor size \> 4 centimeters, Brain herniation

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Khon Kaen University

Nai Muang, KhonKaen, 40002, Thailand

Location

Related Publications (8)

• Ismail SA, Bisher NA, Kandil HW, Mowafi HA, Atawia HA. Intraocular pressure and haemodynamic responses to insertion of the i-gel, laryngeal mask airway or endotracheal tube. Eur J Anaesthesiol. 2011 Jun;28(6):443-8. doi: 10.1097/EJA.0b013e328345a413.

  PMID: 21455075 BACKGROUND

• Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anesthesiology. 2000 Jul;93(1):48-54. doi: 10.1097/00000542-200007000-00012.

  PMID: 10861145 BACKGROUND

• Tada Y, Wada K, Shimada K, Makino H, Liang EI, Murakami S, Kudo M, Kitazato KT, Nagahiro S, Hashimoto T. Roles of hypertension in the rupture of intracranial aneurysms. Stroke. 2014 Feb;45(2):579-86. doi: 10.1161/STROKEAHA.113.003072. Epub 2013 Dec 26.

  PMID: 24370755 BACKGROUND

• Khan FA, Ullah H. Pharmacological agents for preventing morbidity associated with the haemodynamic response to tracheal intubation. Cochrane Database Syst Rev. 2013 Jul 3;2013(7):CD004087. doi: 10.1002/14651858.CD004087.pub2.

  PMID: 23824697 BACKGROUND

• Gerlach AT, Murphy CV. Dexmedetomidine-associated bradycardia progressing to pulseless electrical activity: case report and review of the literature. Pharmacotherapy. 2009 Dec;29(12):1492. doi: 10.1592/phco.29.12.1492.

  PMID: 19947809 BACKGROUND

• Tam S, Chung F, Campbell M. Intravenous lidocaine: optimal time of injection before tracheal intubation. Anesth Analg. 1987 Oct;66(10):1036-8. No abstract available.

  PMID: 3631567 BACKGROUND

• Shribman AJ, Smith G, Achola KJ. Cardiovascular and catecholamine responses to laryngoscopy with and without tracheal intubation. Br J Anaesth. 1987 Mar;59(3):295-9. doi: 10.1093/bja/59.3.295.

  PMID: 3828177 BACKGROUND

• Lee SY, Min JJ, Kim HJ, Hong DM, Kim HJ, Park HP. Hemodynamic effects of topical lidocaine on the laryngoscope blade and trachea during endotracheal intubation: a prospective, double-blind, randomized study. J Anesth. 2014 Oct;28(5):668-75. doi: 10.1007/s00540-014-1812-z. Epub 2014 Mar 12.

  PMID: 24619576 BACKGROUND

Study Officials

• Nattawadee Phokaw, MD

  Department of anesthesiologist, Faculty of Medicine, Khon Kaen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nattawadee Phokaw, MD

CONTACT

+66619719493; Nattapho@kku.ac.th

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 1. Group SL: 10%lidocaine spray total 8 puffs at laryngoscopes blade and endotracheal tube cuff. 2. Group IL: 2% lidocaine intravenous 1.5 mg/kg, not exceed 80 mg equally to spray group.

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 26, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication
• Access Criteria: Researcher who required more information for further study

Locations

TH (1)