80 patients scheduled for complete colonoscopy participated in the study.all patients recived fentanil 1 microgram/kg intravenously.they randomized into two groups .in the etomidate group (n=40),a bolus dose of etomidate 0.1 mg/kg was given ,followed by a continuous infusion at 5 microgram/kg/min .in the propofol group (n=50) a bolus dose of propofol 0.5 mg/kg was given, followed by continuous infusion at 25 microgram/kg/min.Vital signs,pain and sedation scores were recorded at the begining of colonoscopy and then every 5 min throughout the procedure.The quality of analgesia was assessed before hospital discharge and 24 h after the procedure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212195381N4
Registration date:2013-01-07, 1391/10/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-07, 1391/10/18
Registrant information
Name
Nadia Banihashem
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22 38296
Email address
nbanihashem@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research Babol University of Medical Sciences
Expected recruitment start date
2012-07-30, 1391/05/09
Expected recruitment end date
2012-11-25, 1391/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Etomidate-Fentanyl and Propofol -Fentanyl sedation in patients scheduled for colonoscopy
Public title
Comparison of Etomidate-Fentanyl and Propofol -Fentanyl sedation in patients scheduled for colonoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:patients scheduled for comlete elective colonoscopy;ages of 18-55 years;ASA I-II.
exclusion criteria:History of large bowel surgery;pregnancy;patients with psychiatric and emotional disorder;history of addiction;history of allergic reaction;history of pulmonary and metabolic disorders.
Age
From 18 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Babol University of Medical Sciences
Street address
Daneshgah Sq - Ganjafrooz Ave
City
Babol
Postal code
Approval date
2012-07-30, 1391/05/09
Ethics committee reference number
6830/پ/ژ/30
Health conditions studied
1
Description of health condition studied
Patients with intestine diseases who need colonoscopy
ICD-10 code
k63.9
ICD-10 code description
disease of intestine,unspecified
Primary outcomes
1
Description
Pain
Timepoint
Before of discharge
Method of measurement
Visual Analogues Scale
Secondary outcomes
1
Description
Drug adverse effects
Timepoint
Before and after colonoscopy
Method of measurement
Before and after colonoscopy
2
Description
Colonoscopist satisfaction
Timepoint
After colonoscopy
Method of measurement
Numerical rating scale for colonoscopist satisfaction
3
Description
Blood pressure
Timepoint
Every 5 minutes
Method of measurement
Noninvasive cuff measurrment
4
Description
Heart rate
Timepoint
Every 5 minutes
Method of measurement
Pulse counting
Intervention groups
1
Description
Fentanil 1microgram/kg and bolus dose of propofol 0.5 mg/kg was given, followed by continuous infusion at 25microgram/kg/min.
Category
Treatment - Drugs
2
Description
Fentanil 1 microgram/kg intravenously and bolus dose of etomidate 0.1 mg/kg was given,followed by a continuous infusion at5microgram/kg/min
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Ruhani Hospital
Full name of responsible person
Dr Nadia Banihashem
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor of Research Babol University Of Medical Sciences
Full name of responsible person
Dr Amrolah Mostafazadeh
Street address
Daneshgah Square, Ganjafrooz Avenue, Vice-chancellor Of Research
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of Research Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr Nadia Banihashem
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
nbanihashem@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Nadia Banihashem
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
nbanihashem@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Nadia Banihashem
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
banihashem@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)