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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Scheduled ERCP under general anesthesia requiring endotracheal intubation.

• Hepatic dysfunction: Child-Pugh class B or C.

• Age 18-70 years.

• ASA physical status I-III.

Locations
Other Locations
China
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
RECRUITING
Shanghai
Contact Information
Primary
Jian Xie
xjnjmu@163.com
+86-021-20256301
Time Frame
Start Date: 2025-01-17
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 188
Treatments
Experimental: Low-dose cisatracurium plus topical lidocaine aerosol
Induction with propofol 2.5 mg/kg IV, sufentanil 5 mcg IV, remifentanil 2 mcg/kg IV, and cisatracurium 0.05 mg/kg IV. After approximately 2 minutes, the glottis is exposed with a video laryngoscope and 2.4% lidocaine aerosol is sprayed three times onto the vocal cords. Intubation is performed approximately 3 minutes after induction.
Active_comparator: Conventional-dose cisatracurium
Same induction without topical lidocaine; cisatracurium 0.15 mg/kg IV. Intubation approximately 3 minutes after induction using a video laryngoscope.
Related Therapeutic Areas
Sponsors
Leads: Jiangang Song

This content was sourced from clinicaltrials.gov