Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal Endoscopy

NCT ID: NCT05406102

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-10
• Study Completion Date: 2023-06-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

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 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.

Group Type: ACTIVE_COMPARATOR

Propofol group

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

experimental; active comparator

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiang Wang

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Affiliated Tumor Hospital of Zhengzhou University

Zhengzhou, Henan, China

Qinghai University Affiliated Hospital

Xining, Qinghai, 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

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

Xinjiang, Xinjiang, China

Countries

China

Central Contacts

Qiang Wang

Role: CONTACT

dr.wangqiang@139.com

0086-02985323646

Wei Gao

Role: CONTACT

gaowei2906@xjtufh.edu.cn

15209225834

Other Identifiers

XJTUIAF2020LSK-213

Identifier Type: -

Identifier Source: org_study_id