Clinical trial NCT05406102: Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal Endoscopy
Official title: Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal : a Multicenter,Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthetics
Recovery
Drug Effect
Safety
Psychotropic Drugs
Anesthetics, Intravenous
Keywords: Remimazolam
Elderly
Endoscopes, Gastrointestinal
Propofol
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of hyoxemia
timeFrame: two hours
Secondary outcomes:
measure: Incidence of respiratory depression
timeFrame: two hours
measure: Incidence of hypotension
timeFrame: two hours
measure: The time of Improved Aldrete≥9
timeFrame: two hours
measure: The time of discharge score ≥9
timeFrame: two hours
measure: Postoperative cognitive decline rate
timeFrame: two hours
measure: Incidence of postoperative amnesia
timeFrame: two hours
measure: Incidence of postoperative anxiety
timeFrame: two hours
measure: Incidence of postoperative vertigo
timeFrame: two hours
measure: Incidence of postoperative pain
timeFrame: two hours
measure: Adverse events
timeFrame: two hours
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Zhengzhou
country: China
facility: Affiliated Tumor Hospital of Zhengzhou University
state: Henan
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xian Yang Central Hospital
state: Shaanxi
city: Xianyang
country: China
facility: Affiliated Hospital of Shaanxi University of traditional Chinese Medicine
state: Shaanxi
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Xinjiang
country: China
facility: Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
state: Xinjiang
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Qiang Wang
role: STUDY_CHAIR
References: