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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
120
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 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
Peking University People's Hospital
Beijing, Beijing Municipality, China
induction time
The time from the beginning of the drug injection to the time when the patient does not respond to the verbal call
Time frame: day 0
Recovery time
First of 3 consecutive MOAA/S scores of 5 after the last injection of study drug
Time frame: 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.
Time frame: day 0
Observation time in the PACU
the time interval between "endoscope removal" and "departure from the recovery room" （PADS score≥9）
Time frame: day 0
Simple Intelligence Assessment Scale (mini-cog)
1. Ask the subjects to listen carefully and memorize 3 unrelated words, and then repeat (Apple, Watch, Coin); 2. 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); 3. Ask the subject to say the 3 words given previously.
Time frame: Every 4 hours, up to 1 week
Drug dosages
The total single dosage of remimazolam , propofol, etomidate，remifentanil and tosilate.
Time frame: 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).
Time frame: 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)
Time frame: day 0
Level of hypoxia
Oxygen saturation \<90% for more than 1 minute #that share a common Unit of Measure in（%）
Time frame: day 0
Respiratory depression
Respiratory rate \< 8 breaths per minute ,that share a common Unit of Measure in（times）
Time frame: 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（%）
Time frame: Within 24 hours
Supine heart rate[HR]
Supine heart rate\[HR\] in (times)
Time frame: day 0
Systolic, diastolic, blood pressure
Systolic, diastolic, blood pressure in(mmHg)
Time frame: day 0
Assessment of pulse oximetry measurements[SpO2]
Assessment of pulse oximetry measurements\[SpO2\]in(%)
Time frame: day 0
Respiration rate[RR]
Respiration rate\[RR\] in (times)
Time frame: day 0
End-tidal carbon dioxide [EtCO2]
End-tidal carbon dioxide \[EtCO2\] in (%）
Time frame: day 0
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