Comparative Clinical Study of Midazolam and Remimazolam as Sedatives for Colonoscopy in Elderly Patients Aged 60 and Above

Efficacy and Safety of Remimazolam Compared with Midazolam for Sedation During Colonoscopy in Elderly Patients; A Randomized, Non-inferiority Clinical Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0010059

Enrollment

Registered

2024-12-17

Start date

2025-01-01

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : For the experimental group (Remimazolam), an initial dose of 5 mg is administered over at least 1 minute, and the MOAA/S score is measured. The procedure begins if the score is 3 or below. Base

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1 )Male or female aged 60 to 79 years. (2) Scheduled to undergo sedated colonoscopy for diagnostic or therapeutic purposes (therapeutic procedures include polypectomy, hemostasis, decompression, foreign body removal, stenting, etc.). (3) ASA (American Society of Anesthesiology) physical status classification score of I or II. (4) BMI = 40 kg/m². (5) Voluntarily agreed to participate in this clinical study.

Exclusion criteria

Exclusion criteria: (1) Individuals expected to have difficulty with airway intubation (e.g., Mallampati Class 3 or higher). (2) Individuals with a history of respiratory issues that could arise during sedation (e.g., sleep apnea, chronic obstructive pulmonary disease, other respiratory disorders). (3) Individuals with hypersensitivity to remimazolam, benzodiazepines, flumazenil, narcotics, naloxone, or related medications. (4) Pregnant or breastfeeding women. (5) Individuals deemed inappropriate for study participation by the principal investigator. (6) Individuals with a history of drug or alcohol addiction within 2 years prior to study participation.

Design outcomes

Primary

Measure	Time frame
The proportion of cases where the procedure was completed without the administration of additional doses after the initial dose.	—

Secondary

Measure	Time frame
The time taken from the administration of the first sedative to the start of the procedure (MOAA/S score of 3 or below).;Procedure success rate;Total procedure time;The time taken from the administration of the final dose of medication to being fully alert.; The time taken from the administration of the final dose of medication to being fully alert.; The time taken from the end of the procedure to discharge.; The time taken from the administration of the final dose of medication to discharge.;The time taken to return to normal activities after the administration of the final dose of medication.;The total dosage of sedatives and fentanyl administered.;Patient/Endoscopist Satisfaction;The incidence rates of hypotension, bradycardia, hypertension, and hypoxia.	—

Measure

Time frame

The time taken from the administration of the first sedative to the start of the procedure (MOAA/S score of 3 or below).;Procedure success rate;Total procedure time;The time taken from the administration of the final dose of medication to being fully alert.; The time taken from the administration of the final dose of medication to being fully alert.; The time taken from the end of the procedure to discharge.; The time taken from the administration of the final dose of medication to discharge.;The time taken to return to normal activities after the administration of the final dose of medication.;The total dosage of sedatives and fentanyl administered.;Patient/Endoscopist Satisfaction;The incidence rates of hypotension, bradycardia, hypertension, and hypoxia.

—

Countries

Korea, Republic of

Contacts

Public ContactSeung Wook Hong

Asan Medical Center

hswooki@gmail.com+82-2-3010-0160

Outcome results