Colon DiseaseNCT05801757
Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients
A study testing Remimazolam and Propofol in people with Colon Disease, run by Tongji Hospital at 1 site in China.
Trial summary
To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Colon Disease
- What is being tested?
- Remimazolam and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 30 Apr 2024
- Phase
- Interventional
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60-80 years old;
- ASA Level I - III;
- Operation time: 15min~1h;
- BMI18.0-29.9；
Who cannot join
- Emergency surgery;
- Patients with high risk of gastric satiety and reflux aspiration;
- Allergies to benzodiazepines and opioids;
- Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours;
- Abnormal liver and kidney function;
- Previous drug use history;
- Recently participated in other clinical studies;
- Patients who cannot cooperate with communication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sedative Effect of Remidazolam Besylate Continuous Pump Infusion for Colonoscopic Polypectomy in Elderly Patients
To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy.
Read the detailed description
To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy, and to screen the optimal dose of remidazolam, in order to provide a more reasonable and safe sedative and analgesic drug regimen for elderly outpatients undergoing colonoscopic polypectomy.
- Conditions
- Colon Disease
- Being tested
- Remimazolam, Propofol
- Keywords
- colonoscopic polypectomy, elderly patients
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called Remimazolam besylate
Using two different doses of remidazolam for continuous pumping to maintain anesthetic effect
PropofolDrug
Also called Diprivan
propofol 2-3mg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Active comparator | propofol 2-3mg/kg/h Receives: Drug: Propofol |
| R1 group | Experimental | remimazolam 0.5mg/kg/h Receives: Drug: Remimazolam |
| R2 group | Experimental | remimazolam 0.75mg/kg/h Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation success rate
Evaluating the success rate of sedation using the modified MOAA/S scoring table
Measured: 1 day
Secondary outcomes (4)
Intraoperative time record
Anesthesia time; Operation time; Wake up time; PACU time
Measured: Intraoperative
Drug usage
doses of propofol,remimazolam and other drugs used
Measured: 1 day
The incidence of adverse reactions during surgery
includes: body movements, hypoxemia, hypotension, bradycardia; Intraoperative awareness
Measured: 1 day
Incidence of postoperative adverse reactions
Postoperative nausea and vomiting, postoperative pain, hypotension, bradycardia, dizziness
Measured: 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 posted6 Apr 2023
- Study start1 May 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon DiseaseStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind, prospective, randomized controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- aihua Du, Dr., Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801757
- Sponsor's protocol ID
- CIRC
- Status last verified
- Aug 2024
- First submitted
- 26 Mar 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: You can request it from the main researcher
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedative Effect of Remidazolam Besylate Continuous Pump Infusion for Colonoscopic Polypectomy in Elderly Patients
- ClinicalTrials.gov ID
- NCT05801757
- Acronym / sponsor ID
- CIRC
- Conditions
- Colon Disease
- Keywords
- colonoscopic polypectomy, elderly patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 6 Apr 2023 (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.
To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy.
Detailed description
To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy, and to screen the optimal dose of remidazolam, in order to provide a more reasonable and safe sedative and analgesic drug regimen for elderly outpatients undergoing colonoscopic polypectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Single blind, prospective, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Active comparator | Drug: Propofolpropofol 2-3mg/kg/h |
| R1 group | Experimental | Drug: Remimazolamremimazolam 0.5mg/kg/h |
| R2 group | Experimental | Drug: Remimazolamremimazolam 0.75mg/kg/h |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 60-80 years old;
- ASA Level I - III;
- Operation time: 15min~1h;
- BMI18.0-29.9；
Key exclusion criteria (8 listed)
- Emergency surgery;
- Patients with high risk of gastric satiety and reflux aspiration;
- Allergies to benzodiazepines and opioids;
- Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours;
- Abnormal liver and kidney function;
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 |
|---|---|---|
| RemimazolamAlso: Remimazolam besylateUsing two different doses of remidazolam for continuous pumping to maintain anesthetic effect | Drug | R1 group, R2 group |
| PropofolAlso: Diprivanpropofol 2-3mg/kg/h | Drug | Propofol group |
Primary outcome
Sedation success rate
Time frame: 1 day
Evaluating the success rate of sedation using the modified MOAA/S scoring table
4 secondary outcomes
Intraoperative time record
Time frame: Intraoperative
Drug usage
Time frame: 1 day
The incidence of adverse reactions during surgery
Time frame: 1 day
Incidence of postoperative adverse reactions
Time frame: 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 13 Aug 2024.
- Individual participant dataSharing planned: No. You can request it from the main researcher
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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.
aihua Du, Dr. study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam and Propofol in people with Colon Disease, run by Tongji 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 4 inclusion and 8 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 13 Aug 2024. 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.
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?
Sedation success rate (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 13 Aug 2024.