Elderly PatientsNCT05103696
A Comparative Study of Rimazolam and Propofol Combined With Etomidate in Gastroenteroscopy in Elderly Patients
A study testing Remimazolam Besylate and etomidate combined with propofol in people with Elderly Patients and Gastrointestinal Endoscopy, run by Peking University People's Hospital at 1 site in China.
Trial summary
Studies have shown that etomidate combined with propofol in gastroscopy has high safety and lower incidence of hypoxia and hypotension, suggesting the advantages of etomidate combined with propofol in elderly patients. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Elderly Patients, Gastrointestinal Endoscopy, Remimazolam Besylate
- What is being tested?
- Remimazolam Besylate and etomidate combined with propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Mar 2023
- 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
- Patients with asAI-II indications for painless gastroenteroscopy and receiving diagnostic or therapeutic gastroenteroscopy;
- Aged 60-75, body mass index (BMI) 19-28 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 lung infection or upper respiratory tract infection;
- 7. Sleep apnea syndrome, difficult airway (Mallampati score of 3 or 4) or asthma status; 8. Advanced cancer accompanied by extensive intra-abdominal metastasis;
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: Safety and Efficacy of Remazolam in Gastroenteroscopy in Elderly Patients
Studies have shown that etomidate combined with propofol in gastroscopy has high safety and lower incidence of hypoxia and hypotension, suggesting the advantages of etomidate combined with propofol in elderly patients.
Remimazolam Besylate is a 1.1 class new drug that acts on GABA receptors and is metabolized by plasma esterase with fast metabolism time, only 1/7 of midazolam, which may be more suitable for elderly patients. Therefore, this study intends to explore the safety and effectiveness of two sedation schemes in gastroenteroscopy for elderly patients.
Read the detailed description
Before starting the endoscopy procedures, patients were randomly assigned to either Remimazolam Besylate group or propofol combined with etomidate group. The onset time, recovery time, vital signs, postoperative recovery, cognitive function and adverse events were compared.
- Conditions
- Elderly Patients, Gastrointestinal Endoscopy, Remimazolam Besylate, Etomidate Combined With Propofol
- Being tested
- Remimazolam Besylate, etomidate combined with propofol
- Keywords
- Remimazolam Besylate, Etomidate combined with propofol, Gastrointestinal Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam BesylateDrug
Remazolam 7mg for the first time (push time 1min), 2.5mg can be added after 2min according to MOAA/S score, no more than 5 times within 15min
etomidate combined with propofolDrug
Etomidate 0.1mg/kg+1% propofol 0.5mg/kg for the first time ,etomidate0.05mg/kg+ 1% propofol 0.25 mg/kg can be added according to MOAA/S score
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | Patients received remimazolam to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were injected remifentanil 0.3μg/kg (infusion time > 1min) at the first time，When the analgesia was insufficient, Remifentanil can be added according to the situation. Receives: Drug: Remimazolam Besylate |
| EP group | Active comparator | Patients received Etomidate combined with propofol to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were injected remifentanil 0.3μg/kg (infusion time > 1min) at the first time.When the analgesia was insufficient,Remifentanil can be added according to the situation Receives: Drug: etomidate combined with propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction time
The time from the beginning of the drug injection to the time when the patient does not respond to the verbal call
Measured: day 0
Recovery time
First of 3 consecutive MOAA/S scores of 5 after the last injection of study drug
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
Observation time in the PACU
the time interval between "endoscope removal" and "departure from the recovery room" （PADS score≥9）
Measured: day 0
Secondary outcomes (12)
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
Drug dosages
The total single dosage of remimazolam , propofol, etomidate，remifentanil and tosilate.
Measured: day 0
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
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
Level of hypoxia
Oxygen saturation <90% for more than 1 minute #that share a common Unit of Measure in（%）
Measured: day 0
Respiratory depression
Respiratory rate < 8 breaths per minute ,that share a common Unit of Measure in（times）
Measured: day 0
Rate of nause、vomiting、 dizziness、hiccups、 cough choking 、body movement
Rate of nause、vomiting、 dizziness、hiccups、 cough choking 、body movement in （%） Rate of coughing and vomiting in（%）
Measured: Within 24 hours
Supine heart rate[HR]
Supine heart rate[HR] in (times)
Measured: day 0
Systolic, diastolic, blood pressure
Systolic, diastolic, blood pressure 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Oct 2021
- Primary completion1 Dec 2022
- Study completion30 Mar 2023
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103696
- Sponsor's protocol ID
- 2021PHB002-001
- Status last verified
- Jul 2023
- First submitted
- 21 Oct 2021
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remazolam in Gastroenteroscopy in Elderly Patients
- ClinicalTrials.gov ID
- NCT05103696
- Acronym / sponsor ID
- 2021PHB002-001
- Conditions
- Elderly Patients, Gastrointestinal Endoscopy, Remimazolam Besylate, Etomidate Combined With Propofol
- Keywords
- Remimazolam Besylate, Etomidate combined with propofol, Gastrointestinal Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 2 Nov 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.
Studies have shown that etomidate combined with propofol in gastroscopy has high safety and lower incidence of hypoxia and hypotension, suggesting the advantages of etomidate combined with propofol in elderly patients.
Remimazolam Besylate is a 1.1 class new drug that acts on GABA receptors and is metabolized by plasma esterase with fast metabolism time, only 1/7 of midazolam, which may be more suitable for elderly patients. Therefore, this study intends to explore the safety and effectiveness of two sedation schemes in gastroenteroscopy for elderly patients.
Detailed description
Before starting the endoscopy procedures, patients were randomly assigned to either Remimazolam Besylate group or propofol combined with etomidate group. The onset time, recovery time, vital signs, postoperative recovery, cognitive function and adverse events were compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: Remimazolam BesylatePatients received remimazolam to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were injected remifentanil 0.3μg/kg (infusion time > 1min) at the first time，When the analgesia was insufficient, Remifentanil can be added according to the situation. |
| EP group | Active comparator | Drug: etomidate combined with propofolPatients received Etomidate combined with propofol to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were injected remifentanil 0.3μg/kg (infusion time > 1min) at the first time.When the analgesia was insufficient,Remifentanil can be added 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 (2 listed)
- Patients with asAI-II indications for painless gastroenteroscopy and receiving diagnostic or therapeutic gastroenteroscopy;
- Aged 60-75, body mass index (BMI) 19-28 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 (5 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 lung infection or upper respiratory tract infection;
- 7. Sleep apnea syndrome, difficult airway (Mallampati score of 3 or 4) or asthma status; 8. Advanced cancer accompanied by extensive intra-abdominal metastasis;
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 BesylateRemazolam 7mg for the first time (push time 1min), 2.5mg can be added after 2min according to MOAA/S score, no more than 5 times within 15min | Drug | Remimazolam group |
| etomidate combined with propofolEtomidate 0.1mg/kg+1% propofol 0.5mg/kg for the first time ,etomidate0.05mg/kg+ 1% propofol 0.25 mg/kg can be added according to MOAA/S score | Drug | EP group |
Primary outcome
induction time
Time frame: day 0
The time from the beginning of the drug injection to the time when the patient does not respond to the verbal call
Recovery time
Time frame: day 0
First of 3 consecutive MOAA/S scores of 5 after the last injection of study drug
Modified Observer's Assessment of Alertness/Sedation[MOAA/S]
Time frame: day 0
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.
Observation time in the PACU
Time frame: day 0
the time interval between "endoscope removal" and "departure from the recovery room" （PADS score≥9）
12 secondary outcomes
Simple Intelligence Assessment Scale (mini-cog)
Time frame: Every 4 hours, up to 1 week
Drug dosages
Time frame: day 0
Patient overall satisfaction and surgeon satisfaction score
Time frame: day 0
Visual analogue scale (VAS)
Time frame: day 0
Level of hypoxia
Time frame: day 0
Respiratory depression
Time frame: day 0
Rate of nause、vomiting、 dizziness、hiccups、 cough choking 、body movement
Time frame: Within 24 hours
Supine heart rate[HR]
Time frame: day 0
Systolic, diastolic, blood pressure
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
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 14 Jul 2023.
- 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.
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 Besylate and etomidate combined with propofol 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 2 inclusion and 5 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 14 Jul 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?
induction time (time frame: day 0). The study lists 4 primary outcomes in all. 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 14 Jul 2023.