Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal Endoscopy
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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, 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Remimazolam group Patients were slowly injected of 0.08 ug/kg of sufentanil. Patients received remimazolam 0.1mg/kg to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. |
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).
Other Names:
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| Active Comparator: Propofol group Patients were slowly injected of 0.08 ug/kg of sufentanil for 1 min during the examination.Patients received Propofol 1.5mg/kg to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. |
Drug: 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).
Other Names:
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Outcome Measures
Primary Outcome Measures
- Incidence of hyoxemia [two hours]
The proportion of blood oxygen saturation < 90%.
Secondary Outcome Measures
- Incidence of respiratory depression [two hours]
The incidence of respiratory rate < 8 times/min
- Incidence of hypotension [two hours]
The incidence of systolic blood pressure decreased by more than 20% before sedation or systolic blood pressure decreased to ≤ 80 mmHg.
- The time of Improved Aldrete≥9 [two hours]
improved Aldrete≥9 was evaluated every 1 min after the last administration, and the time from the last administration to improved Aldrete score ≥9 .
- The time of discharge score ≥9 [two hours]
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.
- Postoperative cognitive decline rate [two hours]
Changes in MOCA score before and after surgery
- Incidence of postoperative amnesia [two hours]
incidence of anterograde and retrograde amnesia
- Incidence of postoperative anxiety [two hours]
incidence of patients with generalized Anxiety Disorder Scale (GAD-7) score ≥ 10
- Incidence of postoperative vertigo [two hours]
incidence of vertigo patients
- Incidence of postoperative pain [two hours]
incidence of patients with visual analogue scale (VAS) ≥ 4
- Adverse events [two hours]
abnormal clinical symptoms and vital signs, and abnormalities in laboratory tests
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥60, no gender limitation;
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Patients receiving gastroscopy or gastrointestinal endoscope;
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ASA physical status score of I to III;
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18 kg/m² < BMI < 30kg/m²;
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They clearly understand and voluntarily participate in the study and sign informed consent
Exclusion Criteria:
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Endoscopic diagnosis and treatment techniques with complex operation are required;
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Patients with respiratory management difficulties;
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Anemia or Thrombocytopenia;
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Have a history of drug abuse and/or alcohol abuse within 2 years prior to the beginning of the screening period;
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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);
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Allergic or contraindicated to benzodiazepines, opioids, propofol, lidocaine and their components;
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Participated in clinical trials of other drugs as a subject within the last 3 months;
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The investigator considered the patients unfit to participate in the trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
| 5 | Shaanxi Provincial People's Hospital | Xi'an | Shaanxi | China | 029710068 |
| 6 | Xian Yang Central Hospital | Xi'an | Shaanxi | China | |
| 7 | Affiliated Hospital of Shaanxi University of traditional Chinese Medicine | Xianyang | Shaanxi | China | 029712000 |
| 8 | First Hospital of Shanxi Medical University | Taiyuan | Shanxi | China | |
| 9 | Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine | Xinjiang | Xinjiang | China |
Sponsors and Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
Investigators
- Study Chair: Qiang Wang, First Affiliated Hospital Xi'an Jiaotong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XJTUIAF2020LSK-213