Safety Clinical Trial
Official title:
Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal : a Multicenter,Randomized Controlled Study
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 by China. It is a new short-acting GABA(A) receptor agonist. Remimazolam has the advantages of rapid onset, rapid recovery, antagonist, controllable degree of cardiovascular and respiratory depression, low incidence of hypotension and respiratory depression. However, elderly patients as important and special patients, there are still a lack of relevant studies and reports. In order to verify the safety and effectiveness of remimazolam in the gastroenteroscopy treatment of elderly patients, it can reduce the incidence of intraoperative hypotension or respiratory depression rate, improve the quality of recovery of elderly patients.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | June 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Hospital of Lanzhou University | Lanzhou | Gansu |
China | First Hospital of Shanxi Medical University | Taiyuan | Shanxi |
China | First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi |
China | Shaanxi Provincial People's Hospital | Xi'an | Shaanxi |
China | Xian Yang Central Hospital | Xi'an | Shaanxi |
China | Affiliated Hospital of Shaanxi University of traditional Chinese Medicine | Xianyang | Shaanxi |
China | Qinghai University Affiliated Hospital | Xining | Qinghai |
China | Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine | Xinjiang | Xinjiang |
China | Affiliated Tumor Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital Xi'an Jiaotong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of hyoxemia | The proportion of blood oxygen saturation < 90%. | two hours | |
Secondary | Incidence of respiratory depression | The incidence of respiratory rate < 8 times/min | two hours | |
Secondary | Incidence of hypotension | The incidence of systolic blood pressure decreased by more than 20% before sedation or systolic blood pressure decreased to = 80 mmHg. | two hours | |
Secondary | The time of Improved Aldrete=9 | improved Aldrete=9 was evaluated every 1 min after the last administration, and the time from the last administration to improved Aldrete score =9 . | two hours | |
Secondary | The time of discharge score =9 | the discharge score was evaluated every 3 minutes after the modified Aldrete=9, and the time from the last administration to the discharge score =9. | two hours | |
Secondary | Postoperative cognitive decline rate | Changes in MOCA score before and after surgery | two hours | |
Secondary | Incidence of postoperative amnesia | incidence of anterograde and retrograde amnesia | two hours | |
Secondary | Incidence of postoperative anxiety | incidence of patients with generalized Anxiety Disorder Scale (GAD-7) score = 10 | two hours | |
Secondary | Incidence of postoperative vertigo | incidence of vertigo patients | two hours | |
Secondary | Incidence of postoperative pain | incidence of patients with visual analogue scale (VAS) = 4 | two hours | |
Secondary | Adverse events | abnormal clinical symptoms and vital signs, and abnormalities in laboratory tests | two hours |
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