The comparison assessment the sedative effect of propofol-ketamine and propofol-fentanyl in colonoscopy
Design
A randomized clinical trial with parallel groups. 200 patients have randomly divided into intervention groups A and B with a table of random numbers and Randomizer software.
Settings and conduct
The population of this study was aged 18-55 years old who referred to Ayatollah Rouhani Hospital in Babol. Patients are randomly divided into two Intervention groups with a table of random numbers by computer Group A: Fentanyl 0.7 microgram/kg and bolus dose of propofol 1 mg/kg
Group B: propofol 1 mg/kg intravenously and bolus dose of Ketamine 0.5 mg/kg.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients scheduled for complete elective colonoscopy, 18-55 years old, 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
Intervention groups
Group A: Fentanyl 0.7 microgram/kg and bolus dose of propofol 1 mg/kg
Group B: propofol 1 mg/kg intravenously and bolus dose of Ketamine 0.5 mg/kg
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190529043750N1
Registration date:2019-06-18, 1398/03/28
Registration timing:retrospective
Last update:2019-06-18, 1398/03/28
Update count:0
Registration date
2019-06-18, 1398/03/28
Registrant information
Name
mohammad esmaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 8305
Email address
dresmaeili48@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
2018-03-06, 1396/12/15
Actual recruitment end date
2019-03-06, 1397/12/15
Trial completion date
2019-03-06, 1397/12/15
Scientific title
The comparison assessment the sedative effect of propofol-ketamin and propofol-fentanyl in colonoscopy
Public title
Effect of propofol-ketamin and propofol-fentanyl in colonoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients scheduled for comlete elective colonoscopy
18-55 years old
ASA class 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
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Actual sample size reached:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients into two intervention groups Patients are randomly divided into two groups A and B with a table of random numbers (a random number table is a collection of numbers that are generated without a specific pattern or order and completely randomized, then samples are randomly selected by Randomizer software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Approval date
2018-03-03, 1396/12/12
Ethics committee reference number
IR.MUBABOL.HRI.REC.1396.242
Health conditions studied
1
Description of health condition studied
disease of intestine,unspecified
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
Group A: Fentanyl 0.7 microgram/kg and bolus dose of propofol 1 mg/kg
Category
Treatment - Drugs
2
Description
Group B: propofol 1 mg/kg intravenously and bolus dose of Ketamine 0.5 mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Mohammad Esmaeili
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
dresmaeili48@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Reza Ghadimi
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?