Status:
UNKNOWN
Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal Endoscopy
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Anesthetics
Recovery
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
Gastroenteroscopy diagnosis and treatment drugs need to meet the needs of quick onset, quick recovery and less anesthesia complications. Remimazolam is an anesthetic sedative independently developed b...
Detailed Description
Patients are fasted for at least 6 hours and water for at least 2 hours. After entering the gastroscopic room, patients took 0.1 g of dacronin hydrochloride glue in the throat for about 5 minutes, ins...
Eligibility Criteria
Inclusion
- Age ≥60, no gender limitation;
- Patients receiving gastroscopy or gastrointestinal endoscope;
- ASA physical status score of I to III;
- 18 kg/m² \< BMI \< 30kg/m²;
- They clearly understand and voluntarily participate in the study and sign informed consent
Exclusion
- Endoscopic diagnosis and treatment techniques with complex operation are required;
- Patients with respiratory management difficulties;
- Anemia or Thrombocytopenia;
- Have a history of drug abuse and/or alcohol abuse within 2 years prior to the beginning of the screening period;
- Patients with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive medication (sital systolic blood pressure ≥160 mmHg at screening stage, and/or diastolic blood pressure ≥100 mmHg at screening stage);
- Allergic or contraindicated to benzodiazepines, opioids, propofol, lidocaine and their components;
- Participated in clinical trials of other drugs as a subject within the last 3 months;
- The investigator considered the patients unfit to participate in the trial.
Key Trial Info
Start Date :
July 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05406102
Start Date
July 10 2022
End Date
June 1 2023
Last Update
July 1 2022
Active Locations (9)
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1
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
2
Affiliated Tumor Hospital of Zhengzhou University
Zhengzhou, Henan, China
3
Qinghai University Affiliated Hospital
Xining, Qinghai, China
4
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 029710061