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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05406102
Other study ID # XJTUIAF2020LSK-213
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date July 10, 2022
Est. completion date June 1, 2023

Study information

Verified date December 2021
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Qiang Wang
Phone 0086-02985323646
Email dr.wangqiang@139.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


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, instructed the patient to be in the left recumbent position and nasal catheter oxygen (4 L / min), finger oxygen and blood pressure ; after static pushing sufentanil 0.08 μg/kg, respectively, give remimazolam or propofol for sedation; MOAA/S score ≤ 3 , start gastrointestinal endoscopy, maintain MOAA/S ≤ 4 during the operation. After the end of gastrointestinal treatment, the patient is moved to the recovery room for recovery. The evaluators also assessed the incidence of blood oxygen saturation < 90%, the incidence of respiratory rate < 8 times/min, the incidence of hypotension, the time of improved aldrete≥9, the time of discharge score ≥9 points, the postoperative cognitive function, amnesia, anxiety, dizziness, pain, nausea, and adverse events.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Remimazolam
Patients received an initial dose of 0.1mg/kg of remimazolam (add to 0.05 mg/kg top-ups doses to a total of up to five times within 15minutes).
Propofol group
Patients received an initial dose of 1.5mg/kg of propofol(add to 0.5 mg/kg top-ups doses to a total of up to five times within 15minutes).

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

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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