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Completed

NCT Number: NCT07185074

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

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.

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Key information

Conditions

Intubation, Intratracheal Digestive System Diseases Liver Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201203, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Lidocaine aerosol 2.4% topical

Drug

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

Primary outcomes

  1. Clinically acceptable intubation conditions (Cooper score ≥6)

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

    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).

Secondary outcomes

  1. Intubation time (seconds)

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

    Time in seconds measured with a stopwatch.

  2. First-pass success rate

    Time frame: At the intubation attempt following induction

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

  3. Procedure duration (minutes)

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

    Duration recorded from OR system or anesthesia record.

  4. Extubation time (seconds)

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

    Time in seconds measured with a stopwatch.

  5. Operating-room time after ERCP

    Time frame: From scope removal to leaving the operating room

    Duration in minutes.

  6. Severe hemodynamic reaction within 10 minutes after induction

    Time frame: From induction to 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.

  7. Oxygen desaturation events

    Time frame: From induction to PACU discharge

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

  8. Airway complications related to intubation

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

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

  9. Postoperative nausea and vomiting (PONV) within 24 hours

    Time frame: 0-24 hours after surgery

    Presence of nausea and/or vomiting requiring antiemetic therapy.

  10. Sore throat or hoarseness within 24 hours

    Time frame: 0-24 hours after surgery

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

Sponsors and collaborators

Lead sponsor

Jiangang Song

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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