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Evaluation of the sedative effect of nasal dexmedetomidine in endoscopic procedures

Phase 3
Conditions
Indution of sedation for endoscopy in billiary disorders.
Disorders of gallbladder, biliary tract and pancreas in diseases classified elsewhere
Registration Number
IRCT2015103011398N9
Lead Sponsor
Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
50
Inclusion Criteria

Inclusion criteria's are: Age 18-65 years, both sex, having informed consent for entry to the study, ASA physical status class I-III
Exclusion criteria's include: Age less than 18 and over than 65 years, ASA class over than III, history of open surgery in last week before endoscopy, chronic users of opiates & benzodiazepines, bradycardia (HR<45), systolic blood pressure less than 90 mmhg, cardiac conduction abnormality, patients using B-blockers & calcium channel blockers, patients with prolonged QT interval, active bleeding of upper or lower GI tract, patients with hemodynamic instability, pregnant patients, advanced liver insufficiency

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
evel of sedation. Timepoint: Every two min after intervention. Method of measurement: Richmond agitation sedation scale.
Secondary Outcome Measures
NameTimeMethod
Total dose of midazolam and fentanyl useage. Timepoint: End of procedure. Method of measurement: Sum of these drugs in mg/kg.
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