Overview

Comparison Between Remimazolam Tosilate and Midazolam in Elderly Patients Undergoing Gastrointestinal Endoscopy

Status:
Not yet recruiting
Trial end date:
2022-12-30
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking University People's Hospital
Collaborators:
China Meitan General Hospital
First Hospital of Shijiazhuang City
Sinopharm Tongmei(datong) healthcare corporation
The Fifth People's Hospital of Datong
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Treatments:
Midazolam
Criteria
Inclusion Criteria:

1. Scheduled to undergo a routine diagnostic or therapeutic gastrointestinal endoscopy ;

2. Age 60 to 75 ;

3. ASA physical status score of I, II or III;

4. A body mass index (BMI) of 19 to 28 kg/m2;

5. 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:

1. Those who are refused to be included;

2. Those who are allergic to the drugs used in this study;

3. Epilepsy and other mental illnesses, a history of addiction such as opiates and other
analgesics and/or tranquilizers (hypnotics);

4. Severe cardiac dysfunction: NYHA cardiac functions grade 3-4, a history of recent
myocardial infarction or cerebral infarction, severe conduction block or malignant
arrhythmia;

5. Renal failure or liver cirrhosis;

6. 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, acute and chronic
obstruction of the gastrointestinal tract, bleeding and severe abdominal effusion;