Protocol summary

Summary
This study compares the effects and probable complications of two groups of mix of propofol and fentanyle with mix of propofol and ketamin(called ketofol) in sedation in patients should be undergoing diagnostic colonoscopy.Inclusion criteria are: age over 18 years ;age under 80 years;and class 1 in American Society of Anesthesiologists(ASA).Exclusion criteria are: Coronary artery disease; Neurological and psychiatric disease;Egg sensitivities. 90 patients who should be undergoing diagnostic colonoscopy will enrolled in study.Our study will be done in Emam KHomeini hospital.We describe our purpose of research study for patients then after their satisfaction we will be included them in study.Their information about age,gender,past cardiac disease, etiology of colonoscopy,drug consumption will be collect in check list form.Incidently, patient will be divided to two groups,one will be received intra venous mix of propofol-fentanyle,dose of propofol is 0/75mg/kg and fentanyle 1ug/kg,and other group will be recieved intravenous mix of propofol and ketamine that named ketofol.Ketofol solution is made by mixing of 50 mg propofol and 50mg ketamine and 4 cc distilled water in a 10cc syringe.Second group will be received 0/75mg/kg ketofol. Patient sedation level will be differentiated by Ramsay sedation score and patient and physician satisfaction level will be differentiated by visual analogue scale(VAS).In both group sedation level before starting of colonoscopy should be above 5 in ramsay scale,if not, we inject 0/3mg/kg propofol to first group and 0/3 mg/kg ketofol to second group.Median recovery time,additional dose of propofol or ketofol,additional other sedative drug,and complications like vomiting,nausea,chilling,hypoxy,and complication of emergence of ketamin will be determined and compared in both group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012122711909N1
Registration date: 2013-03-24, 1392/01/04
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-03-24, 1392/01/04
Registrant information
Name
hamed marandi
Name of organization / entity
imam khomeini hospital
Country
Iran (Islamic Republic of)
Phone
+98 44206236
Email address
h-marandi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sedation among Intravenous propofol- fentanyle and propofol- ketamine in patients underwent diagnostic colonoscopy.
Public title
Comparison of effect and probable complications of two groups of mix of propofol and fentanyl with mix of propofol and ketamin in sedation in patients should be undergoing diagnostic colonoscopy .
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:age>18years old;age<80years old; ASA1 Exclusion:age<18years old;age>80 years old;cardiovascular disease;coagulopathy;psychatric and neurologic drug user;egg sensitivity.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
N/A
Randomization description
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
Tehran University of Medical Sciences
Street address
Room 206, 1st floor, Number1, Ghods street, Keshavarz street
City
Tehran
Postal code
Approval date
2012-07-11, 1391/04/21
Ethics committee reference number
130/665/د/91

Health conditions studied

1

Description of health condition studied
Sedation
ICD-10 code
F13
ICD-10 code description
Mental and behavioural disorders due to use of sedatives or hypnotics

Primary outcomes

1

Description
Sedation
Timepoint
Before and in colonoscopy
Method of measurement
Ramsy score sedation

Secondary outcomes

1

Description
Satisfaction of patiant and physician
Timepoint
End of colonoscopy
Method of measurement
VAS (visual analouge scale)

2

Description
Recovery
Timepoint
End of colonoscopy
Method of measurement
Time

3

Description
Naueia and vomitting
Timepoint
End of colonoscopy
Method of measurement
Observation

4

Description
Chilling
Timepoint
End of colonoscopy
Method of measurement
Observation

5

Description
Hypoxia
Timepoint
Iin and end of colonoscopy
Method of measurement
Pulse oximetry

6

Description
Blood pressure
Timepoint
Before colonoscopy to end of it every 3 minutes
Method of measurement
Monitoring

7

Description
Emergency complication of ketamin
Timepoint
End of colonoscopy
Method of measurement
Observation

Intervention groups

1

Description
Intervention 1:propofol0.75 mg/kg with fentanyle 1ug/kg IV
Category
Treatment - Other

2

Description
Intervention2:in a 10cc syringe,1cc ketamin+5cc propofol+4cc water,0.75mg/kg IV
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr.Rahmi
Street address
Emam Khomeini hospital, Tohid Sq,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Shahin Akhoondzade
Street address
North door of Tehran University, Poorsina street,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Imam Khomeini hospital
Full name of responsible person
Dr.Rahimi
Position
Professor
Other areas of specialty/work
Street address
Anesthesiology station, Imam Khomeini hospital, Tohid Sq.
City
Tehran
Postal code
Phone
+98 21 6119 2828
Fax
Email
Mrahimi@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Imam Khomeini hospital
Full name of responsible person
Dr.Rahimi
Position
Professor
Other areas of specialty/work
Street address
Anesthesiology station, Imam Khomeini hospital,Tohid Sq.
City
Tehran
Postal code
Phone
+98 21 6119 2828
Fax
Email
Mrahimi@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Imam Khomeini hospital
Full name of responsible person
Dr.Marandi
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Anesthesiology station, Imam Khomeini hospital, Tohid Sq.
City
Tehran
Postal code
Phone
+98 21 6119 2828
Fax
Email
drhamed_m@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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