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Prospective evaluation of new sedative drug during ESD for esophageal cancer

Prospective evaluation of new sedative drug during ESD for esophageal cancer - Evaluation of new sedation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013159
Enrollment
104
Registered
2014-02-14
Start date
2014-02-17
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

esophageal cancer

Interventions

Sedative status during ESD by administering Cercin and opistan Sedative status during ESD by administering Precedex

Sponsors

Department of Gastroenterology, Toranomon Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Squamous cell carcinoma histologically 2)SM2 or less tumor invasion as a preoperative diagnosis 3)no lymph node or distant metastasis by CT 4)obtained written informed consent 5)performance status is 0-2 6)no severe organ dysfunction

Exclusion criteria

Exclusion criteria: 1)uncontrollable DM 2)uncontrollable HT 3)uncontrollable heart disease 4)severe or uncontroallable respiratory disease 5)acute alcoholoic addiction 6)epilepsy 7)oxygen is needed in walking or at rest 8)active bacterial of fungal infection 9)pregnancy 10)psychiatric disease 11)alcoholic liver cirrhosis 12)allergy to opistan 13)administered monoamin oxidase inhibitor 14)acute narrow-angle glaucoma 15)myasthenia gravis 16)administered ritonavir

Design outcomes

Primary

MeasureTime frame
body movement during ESD

Secondary

MeasureTime frame
1.the frequency of hypotention 2.the frequency of bradycardia 3.the frequency of respiratory depression 4.the frequency of complication due to ESD 5.the relationship between repiratory rate and saturation 6.awareness after ESD 7.the number of discontinuation of Precedex 8.sedative level during ESD

Countries

Japan

Contacts

Public ContactToshiro Iizuka

Toranomon Hospital Department of Gastroenterology

t-iizuka@toranomon.gr.jp03-3588-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026