Colonoscopy is now the most common diagnostic and therapeutic procedures in the field of GI medicine. Since this procedure is painful and causes discomfort, patients prefer to be sedated during the procedure, and also do the endoscopist. Traditional methods of sedation in which benzodiazepines and narcotics were used due to serious complications such as respiratory depression and hypotension is now under question and hypnotic drugs such as propofol are used widely, and the major side effect of this drug is apnea. Ketamine is a hypnotic agent with less respiratory side effects but may cause hallucination and loss of patient’s cooperation. Dissociative conscious sedation (SQ ketamine + narcotic) is kind of sedation with less side effects which efficacy has been established in laparoscopic procedures. A unique feature of this approach is to preserve full cooperation of the patient during an invasive procedure. The purpose of this study is to compare the efficacy and adverse events of sedation with propofol and DCS in colonoscopy procedures. 48 patients are divided in to two age and sex matched groups first of which will receive propofol and fentanyl and the second will receive SQ ketamine and fentanyl. Then we will study the quality of sedation and the probable side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205079660N1
Registration date:2012-09-29, 1391/07/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-29, 1391/07/08
Registrant information
Name
Sanaz Sha`bani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3605 0354
Email address
s-shaabani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-09-01, 1391/06/11
Expected recruitment end date
2013-03-01, 1391/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between dissociative conscious sedation and sedation with propofol in patients undergoing colonoscopy procedures
Public title
Comparison between sedation with subcutaneuos ketamine and sedation with propofol in patients undergoing colonoscopy procedures
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: all patients in ASA class 1 or 2 (without underlying disease or with mild underlying disease which is well controlled by medication) undergoing colonoscopy; age between 18-60. Exclusion criteria: any uncontrolled or poor controlled underlying disease; seizure disorders; history of hypersensitivity to egg or any drug; addiction to narcotics; mental retardation or any cognitive disorder.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee, Tehran univercity of medical sciences
Street address
Keshavarz blvd, Ghods ave.
City
Tehran
Postal code
Approval date
2012-05-05, 1391/02/16
Ethics committee reference number
2750/130/د/90
Health conditions studied
1
Description of health condition studied
Mental and behavioural disorders due to use of sedatives or hypnotics
ICD-10 code
F10-19
ICD-10 code description
Mental and behavioural disorders due to use of sedatives or hypnotics
Primary outcomes
1
Description
SPO2
Timepoint
Continuous
Method of measurement
pulse oxiometery
2
Description
blood pressure
Timepoint
every 5 minutes
Method of measurement
noninvasive cuff measurrment
3
Description
heart rate
Timepoint
every 5 minutes
Method of measurement
pulse counting
Secondary outcomes
1
Description
apnea
Timepoint
continuous
Method of measurement
observation
Intervention groups
1
Description
First group will receive 2microgram/kg fentanyl + propofol 50-75 mg/kg during the procedure and if needed additional fentanyl will be added up to 4 micro/kg.
Category
Treatment - Drugs
2
Description
The second group will receive 2microgram/kg fentanyl + 0.6 mg/kg SQ ketamine during the procedure and if needed additional fentanyl up to 4 micro/kg will be added. The site of SQ injection is in front of the fore arm in all patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomaini hospital
Full name of responsible person
Mihan Javid MD
Street address
Keshavarz blvd, Gharib aveneu
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mihan Javid
Street address
Keshavarz Blv, Ghods Avenue
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
Tehran University of Medical Sciences
Full name of responsible person
Sanaz Sha`bani
Position
Resident in anesthesia and critical care
Other areas of specialty/work
Street address
Imam Khomaini Hsp.
City
Tehran
Postal code
Phone
+98 21 61190
Fax
Email
sanazshaabani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mihan Ja`fari Javid
Position
Associated Professor
Other areas of specialty/work
Street address
Imam Khomaini Hsp.
City
Tehran
Postal code
Phone
+98 21 6119 2828
Fax
Email
mihanjavid@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sanaz Sha`bani
Position
resident
Other areas of specialty/work
Street address
Imam Khomaini Hsp
City
Tehran
Postal code
Phone
+98 21 6119 2828
Fax
Email
sanazshaabani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)