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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation time (seconds) | Time in seconds measured with a stopwatch. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiangang Song, MD | Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | 201203 | China |
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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.
| 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. |
|
| At the intubation attempt following induction |
| Procedure duration (minutes) | Duration recorded from OR system or anesthesia record. | From endoscope insertion to scope removal (skin-to-skin for ERCP) |
| Extubation time (seconds) | Time in seconds measured with a stopwatch. | From turning off volatile anesthetic to tracheal tube removal |
| Operating-room time after ERCP | Duration in minutes. | 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. | From induction to 10 minutes after induction |
| Oxygen desaturation events | Number of participants with SpO₂ ≤92% lasting ≥10 seconds or requiring assisted ventilation. | From induction to PACU discharge |
| Airway complications related to intubation | Visible blood on laryngoscope, laryngospasm/stridor, re-intubation, or need for airway interventions. | 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. | 0-24 hours after surgery |
| Sore throat or hoarseness within 24 hours | Patient-reported symptoms assessed via standardized questionnaire (yes/no). | 0-24 hours after surgery |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C101584 | cisatracurium |
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