AnesthesiaPhase 4NCT04969068
The Median Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg
A Phase 4 study testing Remimazolam in people with Anesthesia, run by Tianjin Nankai Hospital at 1 site in China.
Trial summary
Remimazolam has shown promising results for sedation in colonoscopy . Alfentanil is widely used in the analgesia of ERCP . The purpose of the study was to determine the median effective dose of remimazolam for duodenoscopy insertion during ERCP with alfentanil 10µg/kg. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Remimazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2021to 30 Dec 2021
- 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
- Age is between 18 and 85 years
- ASA I and III, levels;
- Patients undergone elective ERCP surgery, non-intubation patients;
Who cannot join
- Chronic pain with long-term use of analgesics, psychotropic substances (including opioids, NSAIDs, sedatives, antidepressants), alcohol abusers, with known drug allergy;
- BMI<18,BMI>30
- Abnormal renal function (BUN or Cr ) ;
- Previous abnormal surgical anesthesia recovery history;
- Hypertension or systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg when the patient admission to the operating room
- Suffering from esophageal reflux; • Sedatives, analgesics and antipruritic drugs were used 24 hours before operation;
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- Expected difficult intubation ;
- Liver surgery history;
- Opioids allergy history;
- Take monoamine oxidase inhibitor or antidepressant within 15 days;
- COPD;
- Pregnant or parturient women;
- Involved in other drug trials within three months;
- Patients who can not communicate well with the researcher
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Nankai Hospital
Tianjin, Tianjin Municipality, 300000
Yu Jianbo, Professor, （022）27435008 ext. （022）27435027, yujianbo11@126.com
About this study
Remimazolam has shown promising results for sedation in colonoscopy . Alfentanil is widely used in the analgesia of ERCP . The purpose of the study was to determine the median effective dose of remimazolam for duodenoscopy insertion during ERCP with alfentanil 10µg/kg.
Read the detailed description
- Title:The median effective dose of remimazolam for duodenoscopy insertion during ERCP with alfentanil 10µg/kg.
- Research center: Single center.
- The population of the study: Age is between 18 and 85 years; ASA I andIII levels; Patients undergone elective ERCP surgery, non-intubation patients;
- Sample size:The sample size was decided based on that of prior literature, which had demonstrated that at least six independent pairs with success/failure duodenoscopy insertion during ERCP are required for reliable estimates of the ED50 of remimazolam with the Dixon's up-and-down method, and data from seven independent pairs of patients were collected for this study. The ED50 (95% confidence interval, CI) of remimazolam for successful duodenoscopy insertion during ERCP was calculated according to the formula of Dixon and Massey.
- Interventions:The dose of remimazolam for each patient was determined by the response of the previously tested patients using the modified Dixon's up-and-down method.The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size). Duodenoscopy insertion was conducted when MOAA/S≤1.The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement).' Movement was defined duodenoscopy insertion a failure was as gross purposeful muscular movement, coughing or vomiting occurring during or within 2 minutes of insertion of duodenoscopy. No movement was depicted when the reactions mentioned earlier were absent.If BIS>75 and MOAA/S > 1 when 3 min after the intravenous injection of remimazolam, it was considered a failure, and the patient received rescue sedation..
- Conditions
- Anesthesia
- Being tested
- Remimazolam
- Keywords
- remimazolam, alfentanil, duodenoscopy insertion, ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Interventions:The dose of remimazolam for each patient was determined by the response of the previously tested patients using the modified Dixon's up-and-down method.The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size). Duodenoscopy insertion was conducted when MOAA/S≤1.The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement).' Movement was defined as duodenoscopy insertion a failure was as gross purposeful muscular movement, coughing or vomiting occurring during or within 2 minutes of insertion of duodenoscopy. No movement was depicted when the reactions mentioned earlier were absent. If BIS>75 and MOAA/S > 1 when 3 min after the intravenous injection of remimazolam, it was considered a failure, and the patient received rescue sedation.
| Study group | Role | What they receive |
|---|---|---|
| The median effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg | Experimental | The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size).The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement)' Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of success duodenoscopy insertion
success duodenoscopy insertion is defined by no body movement
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start23 Jul 2021
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Nankai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianbo Yu, Tianjin Nankai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969068
- Sponsor's protocol ID
- TianjinNK RM007
- Status last verified
- Dec 2021
- First submitted
- 4 Jul 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Median Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg
- ClinicalTrials.gov ID
- NCT04969068
- Acronym / sponsor ID
- TianjinNK RM007
- Conditions
- Anesthesia
- Keywords
- remimazolam, alfentanil, duodenoscopy insertion, ERCP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tianjin Nankai HospitalUniversity, hospital or other
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 20 Jul 2021 (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.
Remimazolam has shown promising results for sedation in colonoscopy . Alfentanil is widely used in the analgesia of ERCP . The purpose of the study was to determine the median effective dose of remimazolam for duodenoscopy insertion during ERCP with alfentanil 10µg/kg.
Detailed description
- Title:The median effective dose of remimazolam for duodenoscopy insertion during ERCP with alfentanil 10µg/kg.
- Research center: Single center.
- The population of the study: Age is between 18 and 85 years; ASA I andIII levels; Patients undergone elective ERCP surgery, non-intubation patients;
- Sample size:The sample size was decided based on that of prior literature, which had demonstrated that at least six independent pairs with success/failure duodenoscopy insertion during ERCP are required for reliable estimates of the ED50 of remimazolam with the Dixon's up-and-down method, and data from seven independent pairs of patients were collected for this study. The ED50 (95% confidence interval, CI) of remimazolam for successful duodenoscopy insertion during ERCP was calculated according to the formula of Dixon and Massey.
- Interventions:The dose of remimazolam for each patient was determined by the response of the previously tested patients using the modified Dixon's up-and-down method.The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size). Duodenoscopy insertion was conducted when MOAA/S≤1.The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement).' Movement was defined duodenoscopy insertion a failure was as gross purposeful muscular movement, coughing or vomiting occurring during or within 2 minutes of insertion of duodenoscopy. No movement was depicted when the reactions mentioned earlier were absent.If BIS>75 and MOAA/S > 1 when 3 min after the intravenous injection of remimazolam, it was considered a failure, and the patient received rescue sedation..
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The median effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg | Experimental | Drug: RemimazolamThe first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size).The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement)' |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age is between 18 and 85 years
- ASA I and III, levels;
- Patients undergone elective ERCP surgery, non-intubation patients;
Key exclusion criteria (14 listed)
- Chronic pain with long-term use of analgesics, psychotropic substances (including opioids, NSAIDs, sedatives, antidepressants), alcohol abusers, with known drug allergy;
- BMI<18,BMI>30
- Abnormal renal function (BUN or Cr ) ;
- Previous abnormal surgical anesthesia recovery history;
- Hypertension or systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg when the patient admission to the operating room
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 |
|---|---|---|
| RemimazolamInterventions:The dose of remimazolam for each patient was determined by the response of the previously tested patients using the modified Dixon's up-and-down method.The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size). Duodenoscopy insertion was conducted when MOAA/S≤1.The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement).' Movement was defined as duodenoscopy insertion a failure was as gross purposeful muscular movement, coughing or vomiting occurring during or within 2 minutes of insertion of duodenoscopy. No movement was depicted when the reactions mentioned earlier were absent. If BIS>75 and MOAA/S > 1 when 3 min after the intravenous injection of remimazolam, it was considered a failure, and the patient received rescue sedation. | Drug | The median effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg |
Primary outcome
The number of success duodenoscopy insertion
Time frame: 1 day
success duodenoscopy insertion is defined by no body movement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
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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.
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 Remimazolam in people with Anesthesia, run by Tianjin Nankai Hospital 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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 10 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianbo Yu, MD (86-22-27435873, yujianbo11@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of success duodenoscopy insertion (time frame: 1 day). 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 10 Jan 2022.