A Comparative Study of Rimazolam and Propofol Combined With Etomidate in Gastroenteroscopy in Elderly Patients
Study Details
Study Description
Brief 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.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Before starting the endoscopy procedures, patients were randomly assigned to either Remimazolam Besylate or propofol combined with etomidate. The effect time, recovery time, vital signs, postoperative recovery, cognitive function and complication were observed.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Remimazolam group 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 slowly injected of 0.3ug/kg of remifentanil during the examination.When the analgesia was insufficient, Remifentanil can be added 5-10 ug each time according to the situation. |
Drug: Remimazolam Besylate
Remazolam 7mg for the first time (push time 1min), 2.5mg can be added after 2min according to MOAA/S score, no more than 4 times within 15min
|
| Active Comparator: EP group 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 slowly injected of 0.3 ug/kg of remifentanil during the examination.When the analgesia was insufficient, Remifentanil can be added 5-10 ug each time according to the situation |
Drug: etomidate combined with propofol
The first dose of etomidate was 0.1mg/kg+1% propofol 0.5mg/kg for sedation, remifentanil 0.3μg/kg (push time > 1min), propofol 5mg-10mg+ etomidate 1-2mg according to MOAA/S score
|
Outcome Measures
Primary Outcome Measures
- oneset time [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 after operation [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] [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.
- Supine heart rate[HR] [day 0]
Supine heart rate[HR] in (times)
- Systolic, diastolic, and mean blood pressure [MBP] [day 0]
Systolic, diastolic, and mean blood pressure [MBP] in(mmHg)
- Assessment of pulse oximetry measurements[SpO2] [day 0]
Assessment of pulse oximetry measurements[SpO2]in(%)
- Respiration rate[RR] [day 0]
Respiration rate[RR] in (times)
- End-tidal carbon dioxide [EtCO2] [day 0]
End-tidal carbon dioxide [EtCO2] in (%）
Secondary Outcome Measures
- Simple Intelligence Assessment Scale (mini-cog) [Every 4 hours, up to 1 week]
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.
- procedure time [day 0]
from the endoscopyinsertio in to the end of procedure)
- Drug dosages [day 0]
The total single dosage of remimazolam , propofol, etomidate，remifentanil and tosilate.
- PACU last time [day 0]
from the entry to PACU to the PADS score≥9
- Patient overall satisfaction and surgeon satisfaction score [day 0]
The patient's overall satisfaction score and surgeon satisfaction score were evaluated by 1-10 points (1mm=completely dissatisfied, 100mm=completely satisfied).
- Visual analogue scale (VAS) [day 0]
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)
- Level of hypoxia [day 0]
Oxygen saturation <90% for more than 1 minute #that share a common Unit of Measure in（%）
- Respiratory depression [day 0]
Respiratory rate < 8 breaths per minute ,that share a common Unit of Measure in（times）
- Rate of nause、vomiting、 dizziness、hiccups、 muscle tremor and injection pain [Within 24 hours]
Rate of nause、vomiting、 dizziness、hiccups、 muscle tremor and injection pain in （%） Rate of coughing and vomiting in（%）
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with asAI-III indications for painless gastroenteroscopy and receiving diagnostic or therapeutic gastroenteroscopy;
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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%
Exclusion Criteria:
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Those who are refused to be included;
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Those who are allergic to the drugs used in this study;
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Epilepsy and other mental illnesses, a history of addiction such as opiates and other analgesics and/or tranquilizers (hypnotics);
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Severe cardiac dysfunction: NYHA cardiac functions grade 3-4, a history of recent myocardial infarction or cerebral infarction, severe conduction block or malignant arrhythmia;
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Renal failure or liver cirrhosis;
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Severe lung infection or upper respiratory tract infection;
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Sleep apnea syndrome, difficult airway (Mallampati score of 3 or 4) or asthma status;
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Advanced cancer accompanied by extensive intra-abdominal metastasis, acute and chronic obstruction of the gastrointestinal tract, bleeding and severe abdominal effusion; -
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University People's Hospital | Beijing | Beijing | China | 100049 |
Sponsors and Collaborators
- Peking University People's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021PHB002-001