Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal Endoscopy

NCT05406102 | Unknown Phase 4 DMC

• 1 other identifier: XJTUIAF2020LSK-213
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Keywords

Remimazolam; Elderly; Endoscopes, Gastrointestinal; Propofol

Outcome Measures

Primary Outcomes (1)

• Incidence of hyoxemia

  The proportion of blood oxygen saturation \< 90%.

  two hours

Secondary Outcomes (10)

• Incidence of respiratory depression

  two hours

• Incidence of hypotension

  two hours

• The time of Improved Aldrete≥9

  two hours

• The time of discharge score ≥9

  two hours

• Postoperative cognitive decline rate

  two hours

Study Arms (2)

Remimazolam group

EXPERIMENTAL

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

Propofol group

ACTIVE COMPARATOR

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

Interventions

Remimazolam 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).

Also known as: experimental

Remimazolam group

Propofol group 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).

Also known as: active comparator

Propofol group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥60, no gender limitation;
• Patients receiving gastroscopy or gastrointestinal endoscope;
• ASA physical status score of I to III;
• kg/m² \< BMI \< 30kg/m²;
• They clearly understand and voluntarily participate in the study and sign informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (9)

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Location

Affiliated Tumor Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Qinghai University Affiliated Hospital

Xining, Qinghai, China

Location

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 029710061, China

Location

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 029710068, China

Location

Xian Yang Central Hospital

Xi'an, Shaanxi, China

Location

Affiliated Hospital of Shaanxi University of traditional Chinese Medicine

Xianyang, Shaanxi, 029712000, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

Xinjiang, Xinjiang, China

Location

MeSH Terms

Interventions

remimazolam

Study Officials

• Qiang Wang

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Qiang Wang

CONTACT

0086-02985323646; dr.wangqiang@139.com

Wei Gao

CONTACT

15209225834; gaowei2906@xjtufh.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: July 10, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 1, 2022

Record last verified: 2021-12

Locations

CN (9)