Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal Endoscopy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Recovery; Drug Effect; Safety; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics
• Intervention / Treatment: Drug: Remimazolam; Drug: Propofol group

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Qiang Wang; Phone Number: 0086-02985323646; Email: dr.wangqiang@139.com
• Study Contact Backup: Name: Wei Gao; Phone Number: 15209225834; Email: gaowei2906@xjtufh.edu.cn

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China
      • The First Hospital of Lanzhou University
  • Henan
    • Zhengzhou, Henan, China
      • Affiliated Tumor Hospital of Zhengzhou University
  • Qinghai
    • Xining, Qinghai, China
      • Qinghai University Affiliated Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 029710068
      • Shaanxi Provincial People's Hospital
    • Xi'an, Shaanxi, China, 029710061
      • First Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shaanxi, China
      • Xian Yang Central Hospital
    • Xianyang, Shaanxi, China, 029712000
      • Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
  • Shanxi
    • Taiyuan, Shanxi, China
      • First Hospital Of ShanXi Medical University
  • Xinjiang
    • Xinjiang, Xinjiang, China
      • Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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: experimental
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: active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hyoxemia	The proportion of blood oxygen saturation < 90%.	two hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of respiratory depression	The incidence of respiratory rate < 8 times/min	two hours
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
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
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
Postoperative cognitive decline rate	Changes in MOCA score before and after surgery	two hours
Incidence of postoperative amnesia	incidence of anterograde and retrograde amnesia	two hours
Incidence of postoperative anxiety	incidence of patients with generalized Anxiety Disorder Scale (GAD-7) score ≥ 10	two hours
Incidence of postoperative vertigo	incidence of vertigo patients	two hours
Incidence of postoperative pain	incidence of patients with visual analogue scale (VAS) ≥ 4	two hours
Adverse events	abnormal clinical symptoms and vital signs, and abnormalities in laboratory tests	two hours

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Chair: Qiang Wang, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 10, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Elderly; Propofol; Remimazolam; Endoscopes, Gastrointestinal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: XJTUIAF2020LSK-213

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No