Comparison Between Remimazolam Tosilate and Midazolam in Elderly Patients Undergoing Gastrointestinal Endoscopy

NCT ID: NCT04656964

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 353 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-12-31

Brief Summary

Midazolam is a commonly used drug in gastrointestinal endoscopy due to the good cardiovascular stability and mild respiratory depression for elderly patients. However, there is the concern about the the longer and less predictable recovery or the potential for repeat sedation when the active metabolite becomes bioavailable. Remimazolam Tosilate is an innovative benzodiazepine with better sedation effect and less recovery or resedation issues than midazolam, which possibly make the drug more suitable in elderly patients. We aim to clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.

Detailed Description

Before starting the endoscopy procedures, patients were randomized to receive remimazolam tosilate or midazolam to maintain sufficient sedation, then remifentanil was slowly injected for patients' sufficient analgesia during the examination. We aim to use patients' recovery time, cognition function and other measurement scales to clarify whether remimazolam tosilate is better than midazolam in elderly patients undergoing gastrointestinal endoscopy.

Conditions

Elderly Patients; Gastrointestinal Endoscopy; Midazolam; Remimazolam

Study Design

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

Study Groups

Remimazolam Tosilate group

Patients received remimazolam tosilate to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were slowly injected of 0.4 ug/kg of remifentanil for 1 min during the examination.When the analgesia was insufficient, Remifentanil can be added 5-10 ug each time according to the situation.

Group Type: EXPERIMENTAL

remimazolam tosilate group

Intervention Type: DRUG

Patients received an initial dose of 0.2mg/kg of remimazolam tosilate(plus repeated 2.5 mg top-ups doses to a total of up to 12.5mg within 15 minutes).

Midazolam group

Patients received midazolam to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. And patients were slowly injected of 0.4 ug/kg of remifentanil for 1 min during the examination.When the analgesia was insufficient, Remifentanil can be added 5-10 ug each time according to the situation.

Group Type: ACTIVE_COMPARATOR

Midazolam group

Intervention Type: DRUG

Patients received an initial dose of 0.03mg/kg of midazolam(One additional dose of 0.015 mg / kg midazolam was allowed).

Interventions

remimazolam tosilate group

Patients received an initial dose of 0.2mg/kg of remimazolam tosilate(plus repeated 2.5 mg top-ups doses to a total of up to 12.5mg within 15 minutes).

Intervention Type: DRUG

Midazolam group

Patients received an initial dose of 0.03mg/kg of midazolam(One additional dose of 0.015 mg / kg midazolam was allowed).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Scheduled to undergo a routine diagnostic or therapeutic gastrointestinal endoscopy ;

2. Age 60 to 75 ;

3. ASA physical status score of I, II or III;

4. A body mass index (BMI) of 19 to 28 kg/m2;

5. Systolic blood pressure of 90-140mmHg, diastolic blood pressure of 50-90mmHg, resting heart rate of 50-100bpm and blood pulse oxygen saturation ≥95%

Exclusion Criteria

1. Those who are refused to be included;

2. Those who are allergic to the drugs used in this study;

3. Epilepsy and other mental illnesses, a history of addiction such as opiates and other analgesics and/or tranquilizers (hypnotics);

4. Severe cardiac dysfunction: NYHA cardiac functions grade 3-4, a history of recent myocardial infarction or cerebral infarction, severe conduction block or malignant arrhythmia;

5. Renal failure or liver cirrhosis;

6. Severe lung infection or upper respiratory tract infection;

7. Sleep apnea syndrome, difficult airway (Mallampati score of 3 or 4) or asthma status;

8. Advanced cancer accompanied by extensive intra-abdominal metastasis, acute and chronic obstruction of the gastrointestinal tract, bleeding and severe abdominal effusion;

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emergency General Hospital

OTHER

Sponsor Role: collaborator

Fenyang Hospital Affiliated to Shanxi Medical University

UNKNOWN

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yi Feng, MD

Chief of Anesthesiology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2020PHB249-01

Identifier Type: -

Identifier Source: org_study_id