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Not yet recruiting NCT06258356

Remimazolam in High Risk ERCP Patients

No phase Interventional the Severity and Duration of Intraoperative Hypotension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remimazolam, placebo.
Who it may be relevant to
Registry conditions: the Severity and Duration of Intraoperative Hypotension. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Exploring the Use of Remimazolam (BYFAVO®) in Patients at High Risk for ERCP to Reduce Intraoperative Hypotension and Assess Safety and Efficacy: A Randomized Controlled Trial

Overview

We conducted a randomized trial to investigate whether the administration of Remimazolam in patients undergoing high-risk endoscopic retrograde cholangiopancreatography (ERCP) could significantly reduce the occurrence of intraoperative hypotension, facilitate rapid induction, and result in fewer associated complications.

Detailed description

Remimazolam is a novel ultra-short-acting benzodiazepine-like anesthetic used for gastrointestinal endoscopic procedures, characterized by predictable sedation duration and rapid recovery. Propofol, commonly used in clinical practice as an intravenous anesthetic, also exhibits rapid onset, short duration, and quick recovery characteristics. To date, there is relatively limited literature comparing the likelihood of intraoperative hypotension during general anesthesia with these two agents in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Additionally, a comparison is needed regarding the frequency of additional sedative doses required during anesthesia induction and the occurrence of major postoperative complications, including pancreatitis.

Therefore, the investigators we conducted a randomized trial to investigate whether the administration of Remimazolam in patients undergoing high-risk ERCP could significantly reduce the occurrence of intraoperative hypotension, facilitate rapid induction, and result in fewer associated complications. The investigators aimed to enroll 60 patients with a 1:1 ratio of ASA III to IV undergoing ERCP. The investigators anticipate that Remimazolam can reduce intraoperative hypotension, acute postoperative pancreatitis, and the occurrence of major organ complications.

Interventions

  • Drug Remimazolam
    novel ultra-short-acting benzodiazepine-like anesthetic.
  • Drug placebo
    normal saline (compared to Remimazolam)

Primary outcome measures

  • the duration and severity of hypotension checklist [Time frame: 1 day (during the ERCP examination)]

Eligibility criteria

Inclusion criteria

  • Male and female subjects aged between 20 and 90 years old;
  • ASA (American Society of Anesthesiologists) class III to IV;
  • Body Mass Index (BMI) between 18 and 30 kg/m².

Exclusion criteria

  • Uncontrolled hypertension or hypotension, or clinically significant coronary artery atherosclerosis heart disease or heart failure;
  • Severe respiratory system disorders;
  • Severe sinus bradycardia, heart conduction block, frequent ventricular arrhythmias, or atrial fibrillation;
  • Clinically significant coagulation disorders;
  • End-stage liver failure or kidney disease requiring dialysis;
  • Emergency surgery;
  • Peripheral artery disease with upper limb functional impairment;
  • Other conditions deemed inappropriate by the investigator, including patients with superficial pharyngeal cancer for whom rapid extubation is not suitable during ERCP.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06258356 · 202310115MIND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗