Intubation, IntratrachealPhase 4NCT07185074
Intubation Conditions During ERCP With Lidocaine Aerosol Plus Low-dose Cisatracurium or Conventional-dose Cisatracurium
A Phase 4 study testing Cisatracurium 0.05 mg/kg IV, Cisatracurium 0.15 mg/kg IV and Lidocaine aerosol 2.4% topical in people with Intubation, Intratracheal, run by Jiangang Song at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- Cisatracurium 0.05 mg/kg IV, Cisatracurium 0.15 mg/kg IV and Lidocaine aerosol 2.4% topical
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2025to 24 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 201203
About this study
Official 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
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.
Read the 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.
- Conditions
- Intubation, Intratracheal
- Being tested
- Cisatracurium 0.05 mg/kg IV, Cisatracurium 0.15 mg/kg IV, Lidocaine aerosol 2.4% topical
- Keywords
- cisatracurium, Topical Anesthesia / Aerosol, Lidocaine, ERCP, Noninferiority Trial, Hepatic Dysfunction
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Cisatracurium 0.15 mg/kg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At the intubation attempt following induction (~3 minutes after induction)
Secondary outcomes (10)
Intubation time (seconds)
Time in seconds measured with a stopwatch.
Measured: 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.
Measured: At the intubation attempt following induction
Procedure duration (minutes)
Duration recorded from OR system or anesthesia record.
Measured: From endoscope insertion to scope removal (skin-to-skin for ERCP)
Extubation time (seconds)
Time in seconds measured with a stopwatch.
Measured: From turning off volatile anesthetic to tracheal tube removal
Operating-room time after ERCP
Duration in minutes.
Measured: 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.
Measured: From induction to 10 minutes after induction
Oxygen desaturation events
Number of participants with SpO₂ ≤92% lasting ≥10 seconds or requiring assisted ventilation.
Measured: From induction to PACU discharge
Airway complications related to intubation
Visible blood on laryngoscope, laryngospasm/stridor, re-intubation, or need for airway interventions.
Measured: 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.
Measured: 0-24 hours after surgery
Sore throat or hoarseness within 24 hours
Patient-reported symptoms assessed via standardized questionnaire (yes/no).
Measured: 0-24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start17 Jan 2025
- Primary completion22 May 2026
- Study completion24 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, IntratrachealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangang Song
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiangang Song, ShuGuang Hospital
- Investigators
- Jiangang Song, MD, Study director, Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185074
- Sponsor's protocol ID
- ERCP20240808
- Status last verified
- May 2026
- First submitted
- 15 Sep 2025
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07185074
- Acronym / sponsor ID
- ERCP20240808
- Conditions
- Intubation, Intratracheal
- Keywords
- cisatracurium, Topical Anesthesia / Aerosol, Lidocaine, ERCP, Noninferiority Trial, Hepatic Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Jiangang SongUniversity, hospital or other
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 24 May 2026 (actual)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose cisatracurium plus topical lidocaine aerosol | Experimental | Drug: Cisatracurium 0.05 mg/kg IV, Drug: Lidocaine aerosol 2.4% topicalInduction 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. |
| Conventional-dose cisatracurium | Active comparator | Drug: Cisatracurium 0.15 mg/kg IVSame induction without topical lidocaine; cisatracurium 0.15 mg/kg IV. Intubation approximately 3 minutes after induction using a video laryngoscope. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisatracurium 0.05 mg/kg IVSingle bolus at induction; used in the experimental arm. Approximate potency reference: 0.05 mg/kg is about 1 x ED95. | Drug | Low-dose cisatracurium plus topical lidocaine aerosol |
| Cisatracurium 0.15 mg/kg IVSingle bolus at induction; used in the active comparator arm. Approximate potency reference: 0.15 mg/kg is about 3 x ED95. | Drug | Conventional-dose cisatracurium |
| Lidocaine aerosol 2.4% topicalThree sprays to the glottic area immediately before intubation; used only in the experimental arm. | Drug | Low-dose cisatracurium plus topical lidocaine aerosol |
Primary outcome
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).
10 secondary outcomes
Intubation time (seconds)
Time frame: From laryngoscope blade passing the incisors to capnography confirmation of tracheal intubation
First-pass success rate
Time frame: At the intubation attempt following induction
Procedure duration (minutes)
Time frame: From endoscope insertion to scope removal (skin-to-skin for ERCP)
Extubation time (seconds)
Time frame: From turning off volatile anesthetic to tracheal tube removal
Operating-room time after ERCP
Time frame: From scope removal to leaving the operating room
Severe hemodynamic reaction within 10 minutes after induction
Time frame: From induction to 10 minutes after induction
Oxygen desaturation events
Time frame: From induction to PACU discharge
Airway complications related to intubation
Time frame: From tracheal intubation to 24 hours after the end of anesthesia.
Postoperative nausea and vomiting (PONV) within 24 hours
Time frame: 0-24 hours after surgery
Sore throat or hoarseness within 24 hours
Time frame: 0-24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiangang Song, MD study director
Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cisatracurium 0.05 mg/kg IV, Cisatracurium 0.15 mg/kg IV and Lidocaine aerosol 2.4% topical in people with Intubation, Intratracheal, run by Jiangang Song at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically acceptable intubation conditions (Cooper score ≥6) (time frame: At the intubation attempt following induction (~3 minutes after induction)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.