Intubation, Intratracheal
Conditions
Keywords
cisatracurium, Topical Anesthesia / Aerosol, Lidocaine, ERCP, Noninferiority Trial, Hepatic Dysfunction
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.
Detailed 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.
Interventions
DRUGCisatracurium 0.05 mg/kg IV
Single bolus at induction; used in the experimental arm. Approximate potency reference: 0.05 mg/kg is about 1 x ED95.
DRUGCisatracurium 0.15 mg/kg IV
Single bolus at induction; used in the active comparator arm. Approximate potency reference: 0.15 mg/kg is about 3 x ED95.
DRUGLidocaine aerosol 2.4% topical
Three sprays to the glottic area immediately before intubation; used only in the experimental arm.
Sponsors
Jiangang Song
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically acceptable intubation conditions (Cooper score ≥6) | 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
| Measure | Time frame | Description |
|---|---|---|
| Intubation time (seconds) | From laryngoscope blade passing the incisors to capnography confirmation of tracheal intubation | Time in seconds measured with a stopwatch. |
| First-pass success rate | At the intubation attempt following induction | Proportion of participants with successful tracheal intubation on the first attempt without rescue cisatracurium. |
| Procedure duration (minutes) | From endoscope insertion to scope removal (skin-to-skin for ERCP) | Duration recorded from OR system or anesthesia record. |
| Extubation time (seconds) | From turning off volatile anesthetic to tracheal tube removal | Time in seconds measured with a stopwatch. |
| Operating-room time after ERCP | From scope removal to leaving the operating room | Duration in minutes. |
| Severe hemodynamic reaction within 10 minutes after induction | 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. |
| Oxygen desaturation events | From induction to PACU discharge | Number of participants with SpO₂ ≤92% lasting ≥10 seconds or requiring assisted ventilation. |
| Airway complications related to intubation | From tracheal intubation to 24 hours after the end of anesthesia. | Visible blood on laryngoscope, laryngospasm/stridor, re-intubation, or need for airway interventions. |
| Postoperative nausea and vomiting (PONV) within 24 hours | 0-24 hours after surgery | Presence of nausea and/or vomiting requiring antiemetic therapy. |
| Sore throat or hoarseness within 24 hours | 0-24 hours after surgery | Patient-reported symptoms assessed via standardized questionnaire (yes/no). |
Countries
China
Contacts
STUDY_DIRECTORJiangang Song, MD
Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
Outcome results
None listed