The objective of this study is evaluation of intranasal dexmedetomidine efficacy for moderate sedation induction in patients during endoscopic retrograde cholangio-pancreatography (ERCP). For this purpose, in a double blinded randomized placebo controlled clinical trial, 50 patients 18-65 years from both sex candidate for ERCP will be enrolled in the study and will be divided in two group (intervention or placebo) randomly. In intervention group, 20 min before the onset of endoscopy, 1 µg/kg of diluted dexmedetomidine in the shape of intra nasal drops and in the control group the same volume of placebo drop (normal saline) will be administer. After the entry of the patients in the endoscopy room and before the onset of procedure, midazolam and fentanyl with titrated and divided dose will be prescribed until the achievement to optimal level of sedation (score I & II Richmond scoring system). Then sedation level, total dose of midazolam & fentanyl usage and occurrence of complications such as apnea and respiratory disasters during ERCP will be recorded and compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015103011398N9
Registration date:2015-11-04, 1394/08/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-04, 1394/08/13
Registrant information
Name
Mohammad Reza Ghodraty
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
m-ghodrati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research & Technology, Iran university of medical sciences
Expected recruitment start date
2014-09-06, 1393/06/15
Expected recruitment end date
2015-03-06, 1393/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intranasal adminstration of dexmedetomidine in providing moderate sedation for patients undergoing ERCP ; a randomized control trial
Public title
Evaluation of the sedative effect of nasal dexmedetomidine in endoscopic procedures
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 64 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical sciences
Street address
Research deputy, 5th floor, central bilding, Iran university of medical sciences, Hemmat high way
City
Tehran
Postal code
Approval date
2013-10-15, 1392/07/23
Ethics committee reference number
9011174053
Health conditions studied
1
Description of health condition studied
Indution of sedation for endoscopy in billiary disorders
ICD-10 code
K87*
ICD-10 code description
Disorders of gallbladder, biliary tract and pancreas in diseases classified elsewhere
Primary outcomes
1
Description
Level of sedation
Timepoint
Every two min after intervention
Method of measurement
Richmond agitation sedation scale
Secondary outcomes
1
Description
Total dose of midazolam and fentanyl useage
Timepoint
End of procedure
Method of measurement
Sum of these drugs in mg/kg
Intervention groups
1
Description
Control Group: Placebo
Category
Placebo
2
Description
Nasal Dexmedetomidine 1 microgram per kg of body weight
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Somayeh Allameh
Street address
Anesthesiology department
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi MD.
Street address
7th Floor, , Department of Internal Medicine, Hazrat-E-Rasoul Hospital, Iran University of Medical Sciences, Niayesh St.,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayeh Allameh MD.
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology department, Firoozgar hospital, Behafarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
d.sallame@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammd Reza Ghodraty MD.
Position
Associate Professor of anesthesiology
Other areas of specialty/work
Street address
Anesthesiology department, Firoozgar hospital, Behafarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8871 2818
Fax
Email
ghodrati.mr@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghodraty MD.
Position
Associate Professor of anesthesiology
Other areas of specialty/work
Street address
Anesthesiology department, Firoozgar hospital, Behafarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8871 2818
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)