None listed
Conditions
Interventions
Drug : Normal saline 0.1 ml/kg/hr before 10 min to start the procedure and midazolam 0.05 mg/kg (maximum initial dose 5mg) just before the procedure started were administered intravenously to cases in
Sponsors
Konkuk University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Among the patient undergoing ESD of stomach under monitored anesthesia care (MAC), a total of 80 individuals who signed the agreement were recruited for the study. Recruited patients were equally divided into two groups, each of 40 patients, by using the assigned patient identification number (PIN).The randomized number table was generated using Excel 2010 (Microsoft Corporation, Redmond, WA, USA). The table was preordered by a researcher who was not involved in the study. Patients were randomly assigned to either one of the two groups (Group I; midazolam group, Group II; dexmedetomidine group), so that both the participants and the staff participating were blinded to the study drug administered except anesthesiologist. To ease keeping the double-blind test, drug administration during the procedure was performed by the anesthesiologist.
Exclusion criteria
Exclusion criteria: The exclusion criteria were as follows: age less than 20 years or more than 80 years; ASA physical status III-IV; pregnancy; history of alcoholism or drug abuse; allergy to any of the drugs like MDZ, DEX, and opioids; patients who refused to sign the consent; serious psychiatric problems.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| comparison of the appropriacy of sedation between the two drugs | — |
Secondary
| Measure | Time frame |
|---|---|
| recovery rapidity ;the procedure time, procedure related-complication rate, the complete resection rate of tumor, satisfaction research of the patients and doctors;the safety and side effect of the drugs | — |
Countries
Korea, Republic of
Contacts
Public ContactSang Pyo Lee
Konkuk University Medical Center
Outcome results
None listed