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Effect of Lidocaine Aerosol Plus Low-dose Cisatracurium vs Conventional-dose Cisatracurium on Intubation Conditions in ERCP - A Randomized Trial

NCT07185074 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2025-09-22

No results posted yet for this study

Summary

This clinical study investigates the effects of lidocaine aerosol as an adjunct to low-dose cisatracurium for endotracheal intubation during ERCP (Endoscopic Retrograde Cholangiopancreatography) procedures. The aim is to assess whether lidocaine aerosol can improve the clinical conditions of intubation to a level comparable to the standard dose of cisatracurium, while reducing the amount of muscle relaxant required. The study also seeks to evaluate the impact of this approach on intubation success, extubation time, and recovery time in the operating room, ultimately improving the efficiency of the operating room. Participants will be randomly assigned to either the low-dose cisatracurium group with lidocaine aerosol or the standard-dose cisatracurium group. The primary outcome is the incidence of clinically acceptable intubation conditions, defined by the Cooper's grading system.

Conditions

  • Intubation, Intratracheal

Interventions

DRUG

Cisatracurium 0.05 mg/kg IV

Single bolus at induction; used in the experimental arm. Approximate potency reference: 0.05 mg/kg is about 1 x ED95.

DRUG

Cisatracurium 0.15 mg/kg IV

Single bolus at induction; used in the active comparator arm. Approximate potency reference: 0.15 mg/kg is about 3 x ED95.

DRUG

Lidocaine aerosol 2.4% topical

Three sprays to the glottic area immediately before intubation; used only in the experimental arm.

Sponsors & Collaborators

  • Jiangang Song

    lead OTHER

Principal Investigators

  • Jiangang Song, MD · Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-17
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07185074 on ClinicalTrials.gov