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

Jiangang Song186 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

186

Interventions

Cisatracurium 0.05 mg/kg IVDRUG

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

Cisatracurium 0.15 mg/kg IVDRUG

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

Lidocaine aerosol 2.4% topicalDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

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

Secondary Outcomes

Intubation time (seconds)

Time in seconds measured with a stopwatch.

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

First-pass success rate

Proportion of participants with successful tracheal intubation on the first attempt without rescue cisatracurium.

Time frame: At the intubation attempt following induction

Procedure duration (minutes)

Duration recorded from OR system or anesthesia record.

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

Extubation time (seconds)

Time in seconds measured with a stopwatch.

Time frame: From turning off volatile anesthetic to tracheal tube removal

Operating-room time after ERCP

Duration in minutes.

Time frame: From scope removal to leaving the operating room

Severe hemodynamic reaction within 10 minutes after induction

Incidence of HR \<45 bpm or \>110 bpm or SBP \<80 mmHg or \>160 mmHg, or need for vasoactive rescue per protocol.

Time frame: From induction to 10 minutes after induction

Oxygen desaturation events

Number of participants with SpO₂ ≤92% lasting ≥10 seconds or requiring assisted ventilation.

Time frame: From induction to PACU discharge

Airway complications related to intubation

Visible blood on laryngoscope, laryngospasm/stridor, re-intubation, or need for airway interventions.

Time frame: From tracheal intubation to 24 hours after the end of anesthesia.

Postoperative nausea and vomiting (PONV) within 24 hours

Presence of nausea and/or vomiting requiring antiemetic therapy.

Time frame: 0-24 hours after surgery

Sore throat or hoarseness within 24 hours

Patient-reported symptoms assessed via standardized questionnaire (yes/no).