Neurologic safety of etomidate-based sedation compared with propofol-based sedation during upper GI endoscopy in patients with liver cirrhosis: A double-blind, randomized controlled trial

Clinical safety and efficacy of etomidate-based sedation compared with propofol-based sedation during upper GI endoscopy in patients with liver cirrhosis: A double-blind, randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004904

Enrollment

208

Registered

2020-04-08

Start date

2017-11-13

Completion date

Unknown

Last updated

2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Fentora buccal tab 100mcg is administered to both the propofol group and the etomidate group participating in the study to prevent the occurrence of myoclonus before sedation. The propofol grou

(150 mg / 15 ml / A) at a sedation-inducing dose and starts the procedure when the MOAA / S scale 0 or 1 is reached. Thereafter, to maintain the MOAA / S scale 0 or 1, the procedure is completed and c

(150mg / 15ml / A) 20mg (2ml) as a maintenance dose. The etomidate group intravenously injects 8mg (4ml) of ETOMIDATE-LIPURO INJ (20mg / 10ml / A) at a sedation induction dose and starts the procedure

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For patients with cirrhosis who meet clinical, biochemical and histological criteria from 18 to 80 years of age who need diagnostic or therapeutic upper gastrointestinal endoscopy.

Exclusion criteria

Exclusion criteria: 1. Clinically confirmed or suspected hepatic coma or subjects with neurological / psychiatric disorders or problems 2. Subjects who have recently taken neuro / psychiatric drugs or who have taken drugs related to metabolism of propofol or etomidate 3. Persons with a past history of risk cases among past sedation endoscopy 4. Subjects who are sensitive to etomidate, propofol or fentanyl, or those who are sensitive to eggs, beans, etc. 5. Subjects with adrenal hypogonadism, chronic steroid therapy, or subjects with porphyria 6. Subjects with severe renal disease (serum creatinine more than 2mg / dL) 7. Pregnant women or those who are breastfeeding 8. Subjects who wish to receive an endoscope without compromising 9. Subject who has not obtained informed consent 10. Subject who has less than 90% oxygen saturation in the absence of oxygen, or less than 95% oxygen saturation despite supply of 2 L / min. 11. Subjects with basal systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 50 mmHg or subjects with mean blood pressure less than 60 mmHg

Design outcomes

Primary

Measure	Time frame
Psychometric tests (Number connection test)	—

Secondary

Measure	Time frame
incidence of each adverse event (hypoxemia, respiratory depression, apnea, hypotension, and arrhythmia);incidence of events that interfered with the procedure (myoclonus or a paradoxical reaction);administered dose of sedatives;changes in vital signs during sedation (heart rate, systolic blood pressure, mean blood pressure and SpO2)	—

Countries

Korea, Republic of

Contacts

Public ContactJang Han Jung

Hallym University Medical Center-Dongtan

Outcome results