Esophageal cancer (SCC)
Conditions
Interventions
Sadation by dexmedetomidine, midazolam and pethidine hydrochloride during esophageal ESD
Sponsors
Department of Gastroenterology,Cancer Institute Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Histologically diagnosed squamous cell carcinoma by endoscopic biopsy 2 SM1 or less in tumor invasion by preoperative diagnosis 3 Located in Ut/Mt/Lt/Ae, and able to perform ESD without intubation 4 No lymph node or distant metastasis by preoperative CT 5 Age is 20-80 6 Performance status is 0-2 7 No severe organ dysfunction 8 Written informed consent are obtained
Exclusion criteria
Exclusion criteria: 1 Uncontrollable hypertention 2 Uncontrollable heart disease or arrhythmia 3 Respiratory disease needed oxygen in rest 4 Unstable angina (newly occurred or worsened in these 3 weeks) or myocardial infarction within 6 months 5 Difficult to discontinue antithrombotic drugs during preoperative period 6 Severe infectious disease needed systemic treatment 7 Patients judged inappropriate by investigator or attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of the cases with no body movement during ESD | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 The frequency of respiratory depression, hypotention and bradycardia 2 Patients' levels of conciousness and suffer 3 Endoscopists' satisfaction level for sedation 4 Efficacy of BIS 5 Total consumed amount of midazolam and pethidine hydrochloride | — |
Countries
Japan
Contacts
Public ContactToshiyuki Yoshio
Cancer Institute Hospital Gastroenterology
Outcome results
None listed