Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments

Kaohsiung Veterans General Hospital

Status and phase: Enrolling; Phase 4

Conditions: Vomiting; Postoperative Complications; Respiratory Depression; Constipation; Postoperative Nausea

Treatments: Drug: Propofol; Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT06777758

KSVGH24-CT8-16

Details and patient eligibility

About

This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes.

Full description

Objective This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes.

Methods The investigators will conduct a prospective, randomized, single-center study. Eligible patients will be randomly allocated into three groups: the first group receiving Propofol alone for moderate sedation anesthesia (control group), the second group receiving Remimazolam alone for anesthesia, and the third group receiving a combination of Propofol and Remimazolam for anesthesia. The investigators will record anesthesia depth (DSA values of BIS), heart rate, blood pressure, oxygen saturation, and other indicators during the procedure, as well as postoperative recovery time, time to consciousness recovery, oxygen desaturation, instances of inadequate anesthesia depth, intraoperative patient movement or recall, surgeon satisfaction, patient satisfaction, readmission rate within 14 days, complications, and length of hospital stay.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects are between 20-80 years old.
• Anesthesiologists rated ASA as between I and III.
• Patients undergoing upper gastrointestinal endoscopic examination or therapy.

Exclusion criteria

• Allergy to Propofol, Remimazolam, or opioid medications.
• Emergency surgery.
• Pregnancy.
• History of malignant hyperthermia.
• Impaired liver or kidney function.
• Airway difficulties due to pharyngeal tumors.
• Refusal to participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Propofol

Active Comparator group

Description:

The patient underwent a routine upper gastrointestinal endoscopy.

Treatment:

Drug: Propofol

Remimazolam

Experimental group

Description:

The patient underwent routine upper gastrointestinal endoscopy and Remimazolam was substituted for Propofol.

Treatment:

Drug: Remimazolam

Propofol + Remimazolam

Experimental group

Description:

The patient underwent routine upper gastrointestinal endoscopy, and the anesthetic drug used was Propofol combined with Remimazolam.

Treatment:

Drug: Remimazolam

Drug: Propofol