Actively Recruiting

Phase 4
Age: 20Years - 80Years
All Genders
ID06777758

Comparison of Remimazolam Alone, Propofol Alone, and Their Combination for Moderate Sedation During Endoscopic Examination and Treatment

Led by Kaohsiung Veterans General Hospital. · Updated on 2025-05-08

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Remimazolam, used alone or combined with Propofol, for moderate sedation anesthesia during endoscopic procedures such as upper gastrointestinal endoscopy. The study aims to determine if combining these drugs improves anesthesia quality and recovery outcomes compared to using each drug alone. This is a prospective, randomized study conducted at a single center, focusing on sedation during endoscopic examinations and treatments. Participants will be randomly assigned to one of three groups: Propofol alone, Remimazolam alone, or a combination of both drugs for sedation during the procedure. Throughout the endoscopic examination, various measures will be recorded including anesthesia depth, heart rate, blood pressure, and oxygen levels. Researchers will also monitor recovery time, consciousness return, episodes of oxygen desaturation, patient movement, recall of the procedure, satisfaction of both patients and surgeons, readmission rates within 14 days, complications, and hospital stay length. During the study, participants will undergo routine upper gastrointestinal endoscopy with their assigned sedation method. Assessments will include monitoring vital signs, anesthesia depth, and collecting data on postoperative nausea, vomiting, pain intensity, and analgesic use. Pain will be evaluated using a visual scale every 15 minutes for one hour after surgery. The main outcome measured is the dose changes of sedative drugs during the procedure. Safety and recovery will be closely observed, with follow-up until the first day after surgery.

CONDITIONS

Brief Title

Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects are between 20 and 80 years old
  • Anesthesiologists rated ASA as between I and III
  • Patients undergoing upper gastrointestinal endoscopic examination or therapy
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of the endoscopic procedure

Participants receive moderate sedation anesthesia using Remimazolam, Propofol, or their combination during upper gastrointestinal endoscopic examinations or treatments.

1 visit (in-person procedure day)

Follow-up

Duration - Up to 1 day post-procedure

Participants are monitored after sedation for recovery time, complications, pain intensity, nausea, and recall of surgery events.

1 to 2 visits including recovery room observation and ward follow-up

Trial Site Locations

Total: 1 location

1

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan, 81362

Actively Recruiting

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Research Team

Y

Yuan-Yi Chia, M.D

C

Chen-Hsiu Chen, Ph.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Remimazolam versus propofol for sedation in gastrointestinal endoscopic procedures: a systematic review and meta-analysis.

Eduardo Cerchi Barbosa, Paula Arruda Espírito Santo, Stefano Baraldo...

https://pubmed.ncbi.nlm.nih.gov/38443286

A randomized, controlled clinical trial comparing remimazolam to propofol when combined with alfentanil for sedation during ERCP procedures.

Shu-An Dong, Yan Guo, Sha-Sha Liu...

https://pubmed.ncbi.nlm.nih.gov/36764022

Remimazolam versus propofol for sedation in gastrointestinal endoscopy and colonoscopy within elderly patients: a meta-analysis of randomized controlled trials.

Wania Ahmer, Sahar Imtiaz, Daniyal Muhammad Alam...

https://pubmed.ncbi.nlm.nih.gov/38261005

A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy.

Douglas K Rex, Raj Bhandari, Taddese Desta...

https://pubmed.ncbi.nlm.nih.gov/29723512

Nonintubated laryngomicrosurgery with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange: A case series.

Shan-Han Yang, Chun-Yu Wu, Wen-Hsuan Tseng...

https://pubmed.ncbi.nlm.nih.gov/30522856