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

Jiangang Song

Status and phase: Enrolling; Phase 4

Conditions: Intubation, Intratracheal

Treatments: Drug: Cisatracurium 0.15 mg/kg IV; Drug: Cisatracurium 0.05 mg/kg IV; Drug: Lidocaine aerosol 2.4% topical

Study type: Interventional

Funder types: Other

Identifiers

NCT07185074

ERCP20240808

Details and patient eligibility

About

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.

Full description

Retrospective registration note. Enrollment began on January 17, 2025, was temporarily paused due to investigator training, and is being reactivated at the time of registration. No changes were made to the prespecified primary outcome or analysis plan. This single-center, randomized (1:1), single-blind trial in adult ERCP patients compares low-dose cisatracurium (≈0.05 mg/kg) plus topical lidocaine aerosol versus conventional-dose cisatracurium (≈0.15 mg/kg). Intubation is performed with a video laryngoscope ~3 min after induction. Primary outcome: clinically acceptable intubation conditions (Cooper score ≥6) at the intubation attempt; key secondary outcomes include intubation time, first-pass success, procedure/OR times, extubation time, and safety through 24 h.

Enrollment: 188 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Severe cardiovascular, cerebrovascular, or respiratory disease judged by investigators to increase risk.
• Predicted difficult airway (e.g., Mallampati IV, mouth opening <3 cm, limited neck extension).
• Suspected gastrointestinal obstruction on preoperative assessment.
• Cervical spine disease with limited neck mobility.
• Child-Pugh class C with hepatic encephalopathy.
• Neuromuscular disease.
• Recurrent laryngeal nerve injury or vocal cord dysfunction.
• Pregnancy or breastfeeding.
• Known allergy/hypersensitivity to any study anesthetic (e.g., cisatracurium, lidocaine, propofol, remifentanil, or sufentanil).
• Refusal to participate in the clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 2 patient groups

Low-dose cisatracurium plus topical lidocaine aerosol

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine aerosol 2.4% topical

Drug: Cisatracurium 0.05 mg/kg IV

Conventional-dose cisatracurium

Active Comparator group

Description:

Same induction without topical lidocaine; cisatracurium 0.15 mg/kg IV. Intubation approximately 3 minutes after induction using a video laryngoscope.

Treatment:

Drug: Cisatracurium 0.15 mg/kg IV