Endoscopic Hemostasis, Sedation
Conditions
Brief summary
Remazolam besylate was used for sedation during endoscopic hemostasis in patients with esophageal and gastric varices rupture and bleeding in liver cirrhosis. The onset time, recovery time and incidence of adverse reactions were observed.
Detailed description
Esophagogastric variceal bleeding (EGVB) is one of the most serious and common complications of liver cirrhosis. Endoscopic hemostasis is the most widely used and important method for the prevention and treatment of EGVB. The treatment of varicose veins hemostasis under gastroscope has the problem of long operation time. Patients are prone to nausea, vomiting and excessive secretions due to nervousness and fear, which affect endoscopic insertion and observation, leading to failure of ligation and massive bleeding, and even death. Therefore, appropriate analgesic and sedative drugs are necessary to ensure endoscopic treatment and improve the prognosis. Remimazolam, an ultra-short-acting benzodiazepine drug, is obtained by introducing metabolizable methyl propionate side chain into midazolam. It may have a good effect on sedation during endoscopic hemostasis in cirrhotic patients with ruptured esophageal and gastric varices.
Interventions
DRUGPropofol
Remifentanil maintenance analgesic dose was 1.2-9 μg/kg/h. If the CPOT score ≥3 at the time of maintenance administration, dose adjustment can be considered. Propofol was used for sedation at a loading dose of 0.5mg/kg and a maintenance dose of 1.5mg/kg/h.
DRUGRemimazolam besylate
Remifentanil was administered at a maintenance dose of 1.2-9 μg/kg/h for analgesia. If CPOT score ≥3 during maintenance administration, dose adjustment could be considered. For sedation, remazolam besylate was given a load of 0.1-0.2mg/kg and a maintenance dose of 0.1-0.3mg/kg/h.
Sponsors
Renmin Hospital of Wuhan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with bleeding from ruptured esophageal and gastric varices * Endoscopic hemostatic treatment was performed * Body Mass Index(BMI)18～28kg/m2
Exclusion criteria
* History or evidence of increased risk of sedation/anesthesia; * Pregnant and lactating women; * Have participated in other drug trials within 30 days prior to enrollment; * those with contraindications to propofol, opioids and their remedies; * Unwilling to sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sedation scores | From the begin to 48 hours after procedure | sedation scores were performed during administration,Richmond Agitation-Sedation Scale（RASS）1\ -2 was defined as compliance,Otherwise, sedation was considered inadequate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse events | Within 2 hours from the start of administration to the end of administration | Any adverse events that occurred during the administration of the drug, such as bradycardia, hypotension, respiratory depression, etc |
| Vital signs | From the begin to 48 hours after procedure | Systolic and Diastolic Blood Pressure |
Countries
China
Contacts
Primary ContactLu Wang
Outcome results
None listed