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

NCT07185074 | Active Not Recruiting Phase 4

• 1 other identifier: ERCP20240808
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cisatracurium; Topical Anesthesia / Aerosol; Lidocaine; ERCP; Noninferiority Trial; Hepatic Dysfunction

Outcome Measures

Primary Outcomes (1)

• Clinically acceptable intubation conditions (Cooper score ≥6)

  Intubation conditions are graded with the Cooper scale (jaw relaxation, vocal cords, response to intubation; each 0-3). Scores ≥6 are counted as clinically acceptable. Assessed by the intubating anesthesiologist (unblinded).

  At the intubation attempt following induction (~3 minutes after induction)

Secondary Outcomes (10)

• Intubation time (seconds)

  From laryngoscope blade passing the incisors to capnography confirmation of tracheal intubation

• First-pass success rate

  At the intubation attempt following induction

• Procedure duration (minutes)

  From endoscope insertion to scope removal (skin-to-skin for ERCP)

• Extubation time (seconds)

  From turning off volatile anesthetic to tracheal tube removal

• Operating-room time after ERCP

  From scope removal to leaving the operating room

Study Arms (2)

Low-dose cisatracurium plus topical lidocaine aerosol

EXPERIMENTAL

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.

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

Conventional-dose cisatracurium

ACTIVE COMPARATOR

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

Drug: Cisatracurium 0.15 mg/kg IV

Interventions

Cisatracurium 0.05 mg/kg IV DRUG

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

Low-dose cisatracurium plus topical lidocaine aerosol

Cisatracurium 0.15 mg/kg IV DRUG

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

Conventional-dose cisatracurium

Lidocaine aerosol 2.4% topical DRUG

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

Low-dose cisatracurium plus topical lidocaine aerosol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangang Song: lead

Study Sites (1)

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201203, China

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

cisatracurium

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Jiangang Song, MD

  Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to allocation. Care providers and investigators who prepare drugs and perform intubation are not blinded. Intubation conditions (Cooper score) are rated by the intubating anesthesiologist (unblinded). Objective secondary outcomes (e.g., intubation time, first-pass success, hemodynamic thresholds) are included to mitigate assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: January 17, 2025
• Primary Completion: April 22, 2026
• Study Completion: April 24, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)