Elderly PatientsNCT04656964
Comparison Between Remimazolam Tosilate and Midazolam in Elderly Patients Undergoing Gastrointestinal Endoscopy
A study testing remimazolam tosilate group and Midazolam group in people with Elderly Patients and Gastrointestinal Endoscopy, run by Peking University People's Hospital at 1 site in China.
Trial summary
Midazolam is a commonly used drug in gastrointestinal endoscopy due to the good cardiovascular stability and mild respiratory depression for elderly patients. However, there is the concern about the the longer and less predictable recovery or the potential for repeat sedation when the active metabolite becomes… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Elderly Patients, Gastrointestinal Endoscopy, Midazolam
- What is being tested?
- remimazolam tosilate group and Midazolam group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 31 Dec 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo a routine diagnostic or therapeutic gastrointestinal endoscopy ;
- Age 60 to 75 ;
- ASA physical status score of I, II or III;
- A body mass index (BMI) of 19 to 28 kg/m2;
- Systolic blood pressure of 90-140mmHg, diastolic blood pressure of 50-90mmHg, resting heart rate of 50-100bpm and blood pulse oxygen saturation ≥95%
Who cannot join
- Those who are refused to be included;
- Those who are allergic to the drugs used in this study;
- Epilepsy and other mental illnesses, a history of addiction such as opiates and other analgesics and/or tranquilizers (hypnotics);
- Severe cardiac dysfunction: NYHA cardiac functions grade 3-4, a history of recent myocardial infarction or cerebral infarction, severe conduction block or malignant arrhythmia;
- Renal failure or liver cirrhosis;
- Severe lung infection or upper respiratory tract infection;
- Sleep apnea syndrome, difficult airway (Mallampati score of 3 or 4) or asthma status;
- Advanced cancer accompanied by extensive intra-abdominal metastasis, acute and chronic obstruction of the gastrointestinal tract, bleeding and severe abdominal effusion;
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100049
About this study
Official title: The Safety and Effectiveness of Remimazolam Tosilate Versus Midazolam in Elderly Patients Undergoing Gastrointestinal Endoscopy: A Multicenter ,Prospective, Double-Blinded, Randomized Controlled Study
Midazolam is a commonly used drug in gastrointestinal endoscopy due to the good cardiovascular stability and mild respiratory depression for elderly patients. However, there is the concern about the the longer and less predictable recovery or the potential for repeat sedation when the active metabolite becomes bioavailable. Remimazolam Tosilate is an innovative benzodiazepine with better sedation effect and less recovery or resedation issues than midazolam, which possibly make the drug more suitable in elderly patients. We aim to clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.
Read the detailed description
Before starting the endoscopy procedures, patients were randomized to receive remimazolam tosilate or midazolam to maintain sufficient sedation, then remifentanil was slowly injected for patients' sufficient analgesia during the examination. We aim to use patients' recovery time, cognition function and other measurement scales to clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.
- Conditions
- Elderly Patients, Gastrointestinal Endoscopy, Midazolam, Remimazolam
- Being tested
- remimazolam tosilate group, Midazolam group
- Keywords
- Remimazolam tosilate, Midazolam, postsedation effect, postsedation safety, cognition function, patients' satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remimazolam tosilate groupDrug
Patients received an initial dose of 0.2mg/kg of remimazolam tosilate(plus repeated 2.5 mg top-ups doses to a total of up to 12.5mg within 15 minutes).
Midazolam groupDrug
Patients received an initial dose of 0.03mg/kg of midazolam(One additional dose of 0.015 mg / kg midazolam was allowed).
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Tosilate group | Experimental | Patients received remimazolam tosilate to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were slowly injected of 0.4 ug/kg of remifentanil for 1 min during the examination.When the analgesia was insufficient, Remifentanil can be added 5-10 ug each time according to the situation. Receives: Drug: remimazolam tosilate group |
| Midazolam group | Active comparator | Patients received midazolam to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were slowly injected of 0.4 ug/kg of remifentanil for 1 min during the examination.When the analgesia was insufficient, Remifentanil can be added 5-10 ug each time according to the situation. Receives: Drug: Midazolam group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time after operation
First of 3 consecutive MOAA/S scores of 5 after the last injection of study drug.
Measured: Day 0
Secondary outcomes (16)
Supine heart rate[HR]
Supine heart rate[HR] in (times)
Measured: Day 0
Modified Observer's Assessment of Alertness/Sedation[MOAA/S]
MOAA/S score ranges from 0 to 5 points, 0 point means patients do not respond to noxious stimulation; 5 point means patients responds readily to name spoken in normal tone. When the Modified Observer's Assessment of Alertness/Sedation [MOAA/S] ≤4 that patients are sufficiently sedated.
Measured: Day 0
Visual analogue scale (VAS)
The visual analogue scale (VAS) score ranges from 0 to 10 points (0mm means patients feel no pain, 100mm means patients feel the most severe pain imaginable)
Measured: Day 0
Post-anesthesia discharge score (PADS)
Post-anesthesia discharge score PADS score ranges from 0 to 10 points. only when the PADS score≥9 that will the patients leave the post-anesthesia care unit(PACU).
Measured: Record within 2 hours ，no more than 6 hours
Perioperative anesthesia effect
Induction time（from the drug administration to the start of endoscopy insertion); procedure time(from the endoscopy insertion to the end of procedure);PACU last time(from the entry to PACU to the PADS score≥9).
Measured: Day 0
Drug dosages
The total single dosage of midazolam, propofol, remifentanil and remimazolam tosilate.
Measured: Day 0
Simple Intelligence Assessment Scale (mini-cog)
- Ask the subjects to listen carefully and memorize 3 unrelated words, and then repeat (Apple, Watch, Coin);
- Ask the subjects to draw the shape of the clock on a blank sheet of paper, and give the subject a time to mark it on the clock (the CDT of the clock drawing test is correct; it can correctly indicate the sequence of the digits and display the given Fixed time);
- Ask the subject to say the 3 words given previously.
Measured: Every 4 hours, up to 1 week.
Patient overall satisfaction and surgeon satisfaction score
The patient's overall satisfaction score and surgeon satisfaction score were evaluated by 1-10 points (1mm=completely dissatisfied, 100mm=completely satisfied).
Measured: Day 0
Systolic, diastolic, and mean blood pressure [MBP]
Systolic, diastolic, and mean blood pressure [MBP] in(mmHg)
Measured: Day 0
Assessment of pulse oximetry measurements[SpO2]
Assessment of pulse oximetry measurements[SpO2]in(%)
Measured: Day 0
Respiration rate[RR]
Respiration rate[RR] in (times)
Measured: Day 0
End-tidal carbon dioxide [EtCO2]
End-tidal carbon dioxide [EtCO2] in (%)
Measured: Day 0
Rate of coughing and vomiting
Rate of coughing and vomiting in（%）
Measured: Within 24 hours
Level of hypoxia
Oxygen saturation <90% for more than 1 minute ，that share a common Unit of Measure in（%）
Measured: Within 24 hours
Respiratory depression
Respiratory rate < 8 breaths per minute ,that share a common Unit of Measure in（times）
Measured: Within 24 hours
Abdominal pain and nausea
Abdominal pain and nausea in （%）
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Apr 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PatientsStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Emergency General Hospital, Fenyang Hospital Affiliated to Shanxi Medical University
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656964
- Sponsor's protocol ID
- 2020PHB249-01
- Status last verified
- Jun 2023
- First submitted
- 5 Nov 2020
- Last updated
- 22 Jun 2023
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of Remimazolam Tosilate Versus Midazolam in Elderly Patients Undergoing Gastrointestinal Endoscopy: A Multicenter ,Prospective, Double-Blinded, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04656964
- Acronym / sponsor ID
- 2020PHB249-01
- Conditions
- Elderly Patients, Gastrointestinal Endoscopy, Midazolam, Remimazolam
- Keywords
- Remimazolam tosilate, Midazolam, postsedation effect, postsedation safety, cognition function, patients' satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Emergency General Hospital, Fenyang Hospital Affiliated to Shanxi Medical University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 Dec 2020 (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.
Midazolam is a commonly used drug in gastrointestinal endoscopy due to the good cardiovascular stability and mild respiratory depression for elderly patients. However, there is the concern about the the longer and less predictable recovery or the potential for repeat sedation when the active metabolite becomes bioavailable. Remimazolam Tosilate is an innovative benzodiazepine with better sedation effect and less recovery or resedation issues than midazolam, which possibly make the drug more suitable in elderly patients. We aim to clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.
Detailed description
Before starting the endoscopy procedures, patients were randomized to receive remimazolam tosilate or midazolam to maintain sufficient sedation, then remifentanil was slowly injected for patients' sufficient analgesia during the examination. We aim to use patients' recovery time, cognition function and other measurement scales to clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Tosilate group | Experimental | Drug: remimazolam tosilate groupPatients received remimazolam tosilate to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were slowly injected of 0.4 ug/kg of remifentanil for 1 min during the examination.When the analgesia was insufficient, Remifentanil can be added 5-10 ug each time according to the situation. |
| Midazolam group | Active comparator | Drug: Midazolam groupPatients received midazolam to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were slowly injected of 0.4 ug/kg of remifentanil for 1 min during the examination.When the analgesia was insufficient, Remifentanil can be added 5-10 ug each time according to the situation. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Scheduled to undergo a routine diagnostic or therapeutic gastrointestinal endoscopy ;
- Age 60 to 75 ;
- ASA physical status score of I, II or III;
- A body mass index (BMI) of 19 to 28 kg/m2;
- Systolic blood pressure of 90-140mmHg, diastolic blood pressure of 50-90mmHg, resting heart rate of 50-100bpm and blood pulse oxygen saturation ≥95%
Key exclusion criteria (8 listed)
- Those who are refused to be included;
- Those who are allergic to the drugs used in this study;
- Epilepsy and other mental illnesses, a history of addiction such as opiates and other analgesics and/or tranquilizers (hypnotics);
- Severe cardiac dysfunction: NYHA cardiac functions grade 3-4, a history of recent myocardial infarction or cerebral infarction, severe conduction block or malignant arrhythmia;
- Renal failure or liver cirrhosis;
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 |
|---|---|---|
| remimazolam tosilate groupPatients received an initial dose of 0.2mg/kg of remimazolam tosilate(plus repeated 2.5 mg top-ups doses to a total of up to 12.5mg within 15 minutes). | Drug | Remimazolam Tosilate group |
| Midazolam groupPatients received an initial dose of 0.03mg/kg of midazolam(One additional dose of 0.015 mg / kg midazolam was allowed). | Drug | Midazolam group |
Primary outcome
Recovery time after operation
Time frame: Day 0
First of 3 consecutive MOAA/S scores of 5 after the last injection of study drug.
16 secondary outcomes
Supine heart rate[HR]
Time frame: Day 0
Modified Observer's Assessment of Alertness/Sedation[MOAA/S]
Time frame: Day 0
Visual analogue scale (VAS)
Time frame: Day 0
Post-anesthesia discharge score (PADS)
Time frame: Record within 2 hours ，no more than 6 hours
Perioperative anesthesia effect
Time frame: Day 0
Drug dosages
Time frame: Day 0
Simple Intelligence Assessment Scale (mini-cog)
Time frame: Every 4 hours, up to 1 week.
Patient overall satisfaction and surgeon satisfaction score
Time frame: Day 0
Systolic, diastolic, and mean blood pressure [MBP]
Time frame: Day 0
Assessment of pulse oximetry measurements[SpO2]
Time frame: Day 0
Respiration rate[RR]
Time frame: Day 0
End-tidal carbon dioxide [EtCO2]
Time frame: Day 0
Rate of coughing and vomiting
Time frame: Within 24 hours
Level of hypoxia
Time frame: Within 24 hours
Respiratory depression
Time frame: Within 24 hours
Abdominal pain and nausea
Time frame: Within 24 hours
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 22 Jun 2023.
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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.
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 study testing remimazolam tosilate group and Midazolam group in people with Elderly Patients and Gastrointestinal Endoscopy, run by Peking University People's 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 5 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 22 Jun 2023. 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?
Recovery time after operation (time frame: Day 0). 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 22 Jun 2023.