Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal Endoscopy

Safety Clinical Trial

Official title:

Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal : a Multicenter,Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05406102
• Other study ID #: XJTUIAF2020LSK-213
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Anesthetics
• Anesthetics, Intravenous
• Drug Effect
• Psychotropic Drugs
• Recovery
• Safety

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