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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Besylate | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| induction time | The time from the beginning of the drug injection to the time when the patient does not respond to the verbal call | day 0 |
| Recovery time | First of 3 consecutive MOAA/S scores of 5 after the last injection of study drug | 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. | day 0 |
| Observation time in the PACU | the time interval between "endoscope removal" and "departure from the recovery room" （PADS score≥9） | day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Simple Intelligence Assessment Scale (mini-cog) |
|
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Inclusion Criteria:
Exclusion Criteria:
7. Sleep apnea syndrome, difficult airway (Mallampati score of 3 or 4) or asthma status; 8. Advanced cancer accompanied by extensive intra-abdominal metastasis;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100049 | China |
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| etomidate combined with propofol | Drug | 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 |
|
| Every 4 hours, up to 1 week |
| Drug dosages | The total single dosage of remimazolam , propofol, etomidate，remifentanil and tosilate. | 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). | 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) | day 0 |
| Level of hypoxia | Oxygen saturation <90% for more than 1 minute #that share a common Unit of Measure in（%） | day 0 |
| Respiratory depression | Respiratory rate < 8 breaths per minute ,that share a common Unit of Measure in（times） | 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（%） | Within 24 hours |
| Supine heart rate[HR] | Supine heart rate[HR] in (times) | day 0 |
| Systolic, diastolic, blood pressure | Systolic, diastolic, blood pressure in(mmHg) | day 0 |
| Assessment of pulse oximetry measurements[SpO2] | Assessment of pulse oximetry measurements[SpO2]in(%) | day 0 |
| Respiration rate[RR] | Respiration rate[RR] in (times) | day 0 |
| End-tidal carbon dioxide [EtCO2] | End-tidal carbon dioxide [EtCO2] in (%） | day 0 |
| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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