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Evaluation of the sedative effect of nasal dexmedetomidine in endoscopic procedures

Effect of intranasal adminstration of dexmedetomidine in providing moderate sedation for patients undergoing ERCP ; a randomized control trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015103011398N9
Enrollment
50
Registered
2015-11-04
Start date
2014-09-06
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Indution of sedation for endoscopy in billiary disorders. Disorders of gallbladder, biliary tract and pancreas in diseases classified elsewhere

Interventions

Intervention 1: Control Group: Placebo. Intervention 2: Nasal Dexmedetomidine 1 microgram per kg of body weight.
Placebo
Treatment - Drugs
Control Group: Placebo
Nasal Dexmedetomidine 1 microgram per kg of body weight

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Level of sedation. Timepoint: Every two min after intervention. Method of measurement: Richmond agitation sedation scale.

Secondary

MeasureTime frame
Total dose of midazolam and fentanyl useage. Timepoint: End of procedure. Method of measurement: Sum of these drugs in mg/kg.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSomayeh Allameh MD.

Iran University of Medical Sciences

d.sallame@gmail.com+98 21 8894 6762

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026