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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
353
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).
Patients received an initial dose of 0.03mg/kg of midazolam(One additional dose of 0.015 mg / kg midazolam was allowed).
Peking University People's Hospital
Beijing, Beijing Municipality, China
Recovery time after operation
First of 3 consecutive MOAA/S scores of 5 after the last injection of study drug.
Time frame: Day 0
Supine heart rate[HR]
Supine heart rate\[HR\] in (times)
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
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
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).
Time frame: 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).
Time frame: Day 0
Drug dosages
The total single dosage of midazolam, propofol, remifentanil and remimazolam tosilate.
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.
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
Systolic, diastolic, and mean blood pressure [MBP]
Systolic, diastolic, and mean blood pressure \[MBP\] 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
Rate of coughing and vomiting
Rate of coughing and vomiting in（%）
Time frame: Within 24 hours
Level of hypoxia
Oxygen saturation \<90% for more than 1 minute ，that share a common Unit of Measure in（%）
Time frame: Within 24 hours
Respiratory depression
Respiratory rate \< 8 breaths per minute ,that share a common Unit of Measure in（times）
Time frame: Within 24 hours
Abdominal pain and nausea
Abdominal pain and nausea in （%）
Time frame: Within 24 hours
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