Comparison of dexmedetomidine(Precedex premix)-remifentanil(Remiva) versus remimazolam(Byfavo)-remifentanil(Remiva) for procedural sedation during endoscopic submucosal dissection of gastric tumor

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0008517

Enrollment

Registered

2023-06-12

Start date

2023-05-19

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

None listed

Interventions

Drug : Dexmedomidine is an alpha 2 adrenaline receptor promoter in the central nervous system and is a sedative that can help maintain stable blood pressure during procedures in that it relieves incre

titrate to desired level of sedation.) Known side effects are known to cause hypotension and bradycardia, but it is known that side effects occur less frequently than conventional sedatives. Remimazo

at least 2 minutes must elapse prior to administration of any supplemental dose.Remifentanil will be administered for the purpose of reducing pain when administering sedatives and will be continuously

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Those who visit the gastroenterology department of the main hospital and become indicators of gastric tumor endoscopic submucosal dissection 2. ECOG 2 or less

Exclusion criteria

Exclusion criteria: 1. Subjects who disagreed with the study 2. Subjects under the age of 20 or those over the age of 80 3. Persons subject to severe mental quality 4. Pregnant women and those who are planning to get pregnant 5. Those with terminal renal failure or creatine clearance of 30ml/min or less 6. ECOG 3 or higher

Design outcomes

Primary

Measure	Time frame
Target Percentage of subjects who do not need a rescue sedative to maintain sedation level, procedure time, complete resection, interfering action during procedure, recoevery time	—

Secondary

Measure	Time frame
complication during procedure, recovery room, procedure related complication	—

Countries

Korea, Republic of

Contacts

Public ContactEo Jin LEE

Konkuk University Medical Center

laiec@naver.com+82-2-2030-6176

Outcome results