A Comparison of procedural sedation drugs during endoscopic submucosal dissection of gastric tumor

Not Applicable

Recruiting

Conditions: Neoplasms

Registration Number: KCT0000938

Lead Sponsor: Konkuk University Medical Center

Brief Summary: OBJECTIVE: Endoscopic submucosal dissection (ESD) is nowadays commonly performed as a treatment for gastric tumor. However, the sedation with midazolam (MDZ) often did not reach a satisfactory sedation during the procedure and the drug could suppress respiration and blood pressure also. The aim was to investigate the safety and efficacy of dexmedetomidine with on-demand MDZ (DEX group) in comparison with MDZ alone (MDZ group) as a sedative during an ESD of gastric tumor. METHODS: Eighty patients undergoing ESD of gastric tumor were randomly assigned to one of two treatment regimens (40 patients of each). We investigated the depth of sedation by using a MOAA/S score (Modified Observers Assessment alertness/sedation), interfering actions of patients, sedation related-adverse events, and the satisfaction degree of the patients and doctors. RESULTS: Eighty patients were randomly assigned to one of two treatment regimens (40 patients of each). There was no statistically significant difference between the two groups regarding age, sex, body mass index, ASA classification, and tumor characteristics. Appropriate sedation rate and the satisfaction degree of the doctors were significantly high in the DEX group. There were more interfering actions of patients in the MDZ group than in the DEX group. There was no difference in the adverse events between the two groups. CONCLUSIONS: DEX with on-demand MDZ for the sedation during gastric ESD is as safe as MDZ alone and the sedation effect of DEX with MDZ is superior to that of MDZ alone.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

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

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.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of the appropriacy of sedation between the two drugs

Secondary Outcome Measures

Name	Time	Method
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