Health TrialsbyHealthPanel

Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments

ConditionsPostoperative ComplicationsRespiratory DepressionPostoperative NauseaVomitingConstipation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-80
SponsorKaohsiung Veterans General Hospital.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects are between 20-80 years old.

Anesthesiologists rated ASA as between I and III.

Patients undergoing upper gastrointestinal endoscopic examination or therapy.

Disqualifiers

Allergy to Propofol, Remimazolam, or opioid medications.

Emergency surgery.

Pregnancy.

History of malignant hyperthermia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remimazolam

    Drug

    Remimazolam

  • Propofol

    Drug

    Propofol dose reduction ratio

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: PropofolActive comparator 1 intervention
Group B: RemimazolamExperimental treatment 1 intervention
Group C: Propofol + RemimazolamExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose change

Change in Propofol dose ratio. (Record total dose, Duration, mg/h/kg)

Time frame
Perioperatively (during upper gastrointestinal endoscopy)

Secondary outcomes

1

Incidence of postoperative nausea and vomiting.

Track postoperative nausea and vomiting episodes.

Time frame
After returning to the ward from the recovery room until before breakfast on the first postoperative day.
2

Time to open eyes after stopping Propofol or Remimazolam.

Eye open minutes after Propofol or Remimazolam stop.

Time frame
The timer starts after the anesthetic is administered.
3

Use of rescue medications during surgery.

Rescue drugs are used during the operation

Time frame
During surgery
4

Analgesic dosage in the recovery room.

Analgesic dosage in the postoperative recovery room.

Time frame
Observation period in the postoperative recovery room

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kaohsiung Veterans General Hospital.

Lead sponsor

Source ClinicalTrials.gov
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