Duodenal SpasmPhase 4LIDO ERCPNCT07333859
Effect of IV Lidocaine on Duodenal Peristalsis and Sedation in ERCP
A Phase 4 study testing Lidocaine Hydrochloride 2% and 0.9 % Normal Saline in people with Duodenal Spasm and ERCP, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the efficacy of intravenous lidocaine infusion on duodenal peristalsis during Endoscopic Retrograde Cholangiopancreatography (ERCP). The study compares lidocaine against a placebo to determine if lidocaine can reduce the need for rescue spasmolytics (hyoscine-N-butylbromide or glucagon)… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Duodenal Spasm, ERCP, Sedation
- What is being tested?
- Lidocaine Hydrochloride 2% and 0.9 % Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2026to 15 Mar 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective ERCP.
- ASA Physical Status I, II, or III.
- Age between 18 and 85 years.
- Provided written informed consent.
Who cannot join
- Allergy to amide-type local anesthetics.
- Severe hepatic or renal failure.
- History of AV block or severe cardiac arrhythmia.
- Pregnancy or lactation.
- Chronic opioid use.
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Lidocaine Infusion on Duodenal Peristalsis, Sedation Quality and Rescue Spasmolytic Requirement in ERCP Procedures: A Randomized, Double-Blind, Placebo-Controlled Study
This study aims to evaluate the efficacy of intravenous lidocaine infusion on duodenal peristalsis during Endoscopic Retrograde Cholangiopancreatography (ERCP). The study compares lidocaine against a placebo to determine if lidocaine can reduce the need for rescue spasmolytics (hyoscine-N-butylbromide or glucagon), decrease propofol consumption, and improve hemodynamic stability.
Read the detailed description
Duodenal peristalsis can hinder successful cannulation during ERCP. Traditionally, antispasmodics like hyoscine-N-butylbromide are used but have side effects. This randomized, double-blind, placebo-controlled trial includes 120 patients (ASA I-III) undergoing elective ERCP. "All patients will undergo a standardized sedation protocol managed by an anesthesiologist. Sedation induction will be performed with a loading dose of propofol (0.5-1 mg/kg). Maintenance of sedation will be achieved through a continuous infusion of propofol (40-60 µg/kg/min), supplemented by intermittent bolus doses of 20-30 mg as clinically required. The sedation level will be dynamically titrated by the physician to maintain a target Ramsay Sedation Scale (RSS) score of 3-4 and Bispectral Index (BIS) values between 60 and 80. This approach ensures patient comfort and procedural stability while minimizing respiratory depression
Patients will be randomized 1:1 into two groups:
Group L (Lidocaine): IV bolus 1.0 mg/kg before induction + 2.0 mg/kg/h continuous infusion during the procedure.
Group C (Control): Equal volume of 0.9% Saline. Primary outcome is the "Rescue Spasmolytic Requirement" based on endoscopist's evaluation. Secondary outcomes include duodenal peristalsis score (Suzuki Scale) assessed via video review by a blinded endoscopist, total propofol consumption, and recovery times.
- Conditions
- Duodenal Spasm, ERCP, Sedation
- Being tested
- Lidocaine Hydrochloride 2%, 0.9 % Normal Saline
- Keywords
- lidocaine, Peristalsis, Intravenous Anesthesia, deep sedation, Duodenoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Hydrochloride 2%Drug
1.0 mg/kg IV bolus followed by 2.0 mg/kg/h IV infusion during the procedure. Propofol Induction: 0.5-1 mg/kg loading dose, Maintenance: Continuous infusion of 40-60 µg/kg/min, supplemented by intermittent 20-30 mg boluses as clinically required.
0.9 % Normal SalineOther
IV bolus and infusion of 0.9% NaCl matched in volume and rate to the study drug.
Propofol Induction: 0.5-1 mg/kg loading dose, Maintenance: Continuous infusion of 40-60 µg/kg/min, supplemented by intermittent 20-30 mg boluses as clinically required..
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Group | Experimental | 1.0 mg/kg IV bolus followed by 2.0 mg/kg/h IV infusion during the procedure. Receives: Drug: Lidocaine Hydrochloride 2% |
| Placebo Group | Placebo comparator | IV bolus and infusion of 0.9% NaCl matched in volume and rate to the study drug. Receives: Other: 0.9 % Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue Spasmolytic Requirement Rate
The proportion of patients requiring rescue medication (Hyoscine-N-butylbromide or Glucagon) due to severe duodenal spasm preventing cannulation.
Measured: Intraoperative (During the ERCP procedure, approx. 30 minutes)
Secondary outcomes (1)
Total Propofol Consumption
The total amount of intravenous propofol (measured in milligrams) required to maintain the target sedation depth (RSS 3-4 and BIS 60-80) from the start of induction until the completion of the ERCP procedure.
Measured: From induction until the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start11 Feb 2026
- Primary completion11 Feb 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Duodenal SpasmStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet sahap, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333859
- Sponsor's protocol ID
- ERCP-LIDO-2026-01
- Other IDs
- MEHMET SAHAP
- Acronym
- LIDO ERCP
- Status last verified
- Feb 2026
- First submitted
- 30 Dec 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "Individual participant data will not be shared due to privacy concerns and the lack of a dedicated data management infrastructure to ensure secure anonymization.
Publications
Suzuki M, Sekino Y, Hosono K, Kurita Y, Uechi H, Kuzuu K, Uchiyama S, Kawana K, Nagase H, Kubota K, Yoneda M, Nakajima A. Inhibitory Effect of Lidocaine on Duodenal Peristalsis During Endoscopic Retrograde Cholangiopancreatography: A Multicenter, Randomized Controlled Trial (With Video). DEN Open. 2025 Nov 27;6(1):e70252. doi: 10.1002/deo2.70252. eCollection 2026 Apr.
PubMed 41321955Abrahams M, Derby R, Horn JL. Update on Ultrasound for Truncal Blocks: A Review of the Evidence. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):275-88. doi: 10.1097/AAP.0000000000000372.
PubMed 26866299Busch R, Murti K, Liu J, Patra AK, Muhammad K, Knobeloch KP, Lichtinger M, Bonifer C, Wortge S, Waisman A, Reifenberg K, Ellenrieder V, Serfling E, Avots A. NFATc1 releases BCL6-dependent repression of CCR2 agonist expression in peritoneal macrophages from Saccharomyces cerevisiae infected mice. Eur J Immunol. 2016 Mar;46(3):634-46. doi: 10.1002/eji.201545925. Epub 2016 Jan 8.
PubMed 26631626
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Lidocaine Infusion on Duodenal Peristalsis, Sedation Quality and Rescue Spasmolytic Requirement in ERCP Procedures: A Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07333859
- Acronym / sponsor ID
- LIDO ERCP / ERCP-LIDO-2026-01
- Conditions
- Duodenal Spasm, ERCP, Sedation
- Keywords
- lidocaine, Peristalsis, Intravenous Anesthesia, deep sedation, Duodenoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 12 Jan 2026 (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 study aims to evaluate the efficacy of intravenous lidocaine infusion on duodenal peristalsis during Endoscopic Retrograde Cholangiopancreatography (ERCP). The study compares lidocaine against a placebo to determine if lidocaine can reduce the need for rescue spasmolytics (hyoscine-N-butylbromide or glucagon), decrease propofol consumption, and improve hemodynamic stability.
Detailed description
Duodenal peristalsis can hinder successful cannulation during ERCP. Traditionally, antispasmodics like hyoscine-N-butylbromide are used but have side effects. This randomized, double-blind, placebo-controlled trial includes 120 patients (ASA I-III) undergoing elective ERCP. "All patients will undergo a standardized sedation protocol managed by an anesthesiologist. Sedation induction will be performed with a loading dose of propofol (0.5-1 mg/kg). Maintenance of sedation will be achieved through a continuous infusion of propofol (40-60 µg/kg/min), supplemented by intermittent bolus doses of 20-30 mg as clinically required. The sedation level will be dynamically titrated by the physician to maintain a target Ramsay Sedation Scale (RSS) score of 3-4 and Bispectral Index (BIS) values between 60 and 80. This approach ensures patient comfort and procedural stability while minimizing respiratory depression
Patients will be randomized 1:1 into two groups:
Group L (Lidocaine): IV bolus 1.0 mg/kg before induction + 2.0 mg/kg/h continuous infusion during the procedure.
Group C (Control): Equal volume of 0.9% Saline. Primary outcome is the "Rescue Spasmolytic Requirement" based on endoscopist's evaluation. Secondary outcomes include duodenal peristalsis score (Suzuki Scale) assessed via video review by a blinded endoscopist, total propofol consumption, and recovery times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Group | Experimental | Drug: Lidocaine Hydrochloride 2%1.0 mg/kg IV bolus followed by 2.0 mg/kg/h IV infusion during the procedure. |
| Placebo Group | Placebo comparator | Other: 0.9 % Normal SalineIV bolus and infusion of 0.9% NaCl matched in volume and rate to the study drug. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for elective ERCP.
- ASA Physical Status I, II, or III.
- Age between 18 and 85 years.
- Provided written informed consent.
Key exclusion criteria (6 listed)
- Allergy to amide-type local anesthetics.
- Severe hepatic or renal failure.
- History of AV block or severe cardiac arrhythmia.
- Pregnancy or lactation.
- Chronic opioid use.
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 |
|---|---|---|
| Lidocaine Hydrochloride 2%1.0 mg/kg IV bolus followed by 2.0 mg/kg/h IV infusion during the procedure. Propofol Induction: 0.5-1 mg/kg loading dose, Maintenance: Continuous infusion of 40-60 µg/kg/min, supplemented by intermittent 20-30 mg boluses as clinically required. | Drug | Lidocaine Group |
| 0.9 % Normal SalineIV bolus and infusion of 0.9% NaCl matched in volume and rate to the study drug. Propofol Induction: 0.5-1 mg/kg loading dose, Maintenance: Continuous infusion of 40-60 µg/kg/min, supplemented by intermittent 20-30 mg boluses as clinically required.. | Other | Placebo Group |
Primary outcome
Rescue Spasmolytic Requirement Rate
Time frame: Intraoperative (During the ERCP procedure, approx. 30 minutes)
The proportion of patients requiring rescue medication (Hyoscine-N-butylbromide or Glucagon) due to severe duodenal spasm preventing cannulation.
1 secondary outcome
Total Propofol Consumption
Time frame: From induction until the end of the procedure
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 8 Apr 2026.
- Background: PubMed 41321955Suzuki M, Sekino Y, Hosono K, Kurita Y, Uechi H, Kuzuu K, Uchiyama S, Kawana K, Nagase H, Kubota K, Yoneda M, Nakajima A. Inhibitory Effect of Lidocaine on Duodenal Peristalsis During Endoscopic Retrograde Cholangiopancreatography: A Multicenter, Randomized Controlled Trial (With Video). DEN Open. 2025 Nov 27;6(1):e70252. doi: 10.1002/deo2.70252. eCollection 2026 Apr.
- Background: PubMed 26866299Abrahams M, Derby R, Horn JL. Update on Ultrasound for Truncal Blocks: A Review of the Evidence. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):275-88. doi: 10.1097/AAP.0000000000000372.
- Background: PubMed 26631626Busch R, Murti K, Liu J, Patra AK, Muhammad K, Knobeloch KP, Lichtinger M, Bonifer C, Wortge S, Waisman A, Reifenberg K, Ellenrieder V, Serfling E, Avots A. NFATc1 releases BCL6-dependent repression of CCR2 agonist expression in peritoneal macrophages from Saccharomyces cerevisiae infected mice. Eur J Immunol. 2016 Mar;46(3):634-46. doi: 10.1002/eji.201545925. Epub 2016 Jan 8.
- Individual participant dataSharing planned: No. "Individual participant data will not be shared due to privacy concerns and the lack of a dedicated data management infrastructure to ensure secure anonymization.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lidocaine Hydrochloride 2% and 0.9 % Normal Saline in people with Duodenal Spasm and ERCP, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 6 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 8 Apr 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Rescue Spasmolytic Requirement Rate (time frame: Intraoperative (During the ERCP procedure, approx. 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07333859, which also lists 3 linked publications.
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 8 Apr 2026.