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ACTIVE NOT RECRUITING
NCT07185074
PHASE4

Intubation Conditions During ERCP With Lidocaine Aerosol Plus Low-dose Cisatracurium or Conventional-dose Cisatracurium

Sponsor: Jiangang Song

View on ClinicalTrials.gov

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.

Official title: Effect of Lidocaine Aerosol Combined With Low-dose Cisatracurium vs. Conventional-dose Cisatracurium on Intubation Condition in Patients Undergoing ERCP: a Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

188

Start Date

2025-01-17

Completion Date

2026-04-24

Last Updated

2026-04-02

Healthy Volunteers

No

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.

Locations (1)

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China