Predicted compromised airway is absolute indication for general anesthesia and preserving spontaneous breathing is of great importance in these patients. Rigid bronchoscopy in order to dilate the stenotic trachea needs general anesthesia by preserving spontaneous breathing. Dissociative Conscious Sedation (DCS) by employing subcutaneous ketamine plus narcotic is a new method of sedation with few side effects. The aim of this method is preserving patient`s safety by applying spontaneous ventilation beside effective anesthesia and amnesia. The 48 patients are divided in to two groups each including 24 cases. Inclusion criteria is 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 is 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. The first group will receive midazolam + fentanyl as premedication and na thiopental + atracurium for induction. The second group will receive fentanyl + 0.6 mg/kg SQ ketamine+ morphine during the procedure. At the end of the study two groups will be comparing in hemodynamic parameters and side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210199660N2
Registration date:2012-11-25, 1391/09/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-25, 1391/09/05
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
2012-03-01, 1390/12/11
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
Subcutaneous Dissociative Conscious Sedation (CDS) an Alternative Method for General Anesthesia in Rigid Bronchoscopy (A New Approach)
Public title
Subcutaneous Dissociative Conscious Sedation (CDS) an Alternative Method for General Anesthesia in Rigid Bronchoscopy
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)
Single 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
2010-08-20, 1389/05/29
Ethics committee reference number
62086
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
The first group will resieve 1mg midazolam + 2 micro/kg fentanyl as premedication and 5mg/kg na thiopental + 0.6 mg/kg atracurium for induction.
Category
Treatment - Drugs
2
Description
The second group will receive1mg midazulam+ 2microgram/kg fentanyl + 0.6 mg/kg SQ ketamine+ 0.1mg/kg morphine during the procedure. The site of SQ injection is in front of the fore arm in all patients. Drug administration and monitorings all are done by a resident of anesthesiology in train. and all the intubations will be perform by a single person who is a resident of anesthesiology in train.
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. Shahin Akhondzadeh
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
+98 21 6119 2828
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 Hospital
City
Tehran
Postal code
Phone
+98 21 61190
Fax
+98 21 6119 2828
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 in anesthesia and critical care
Other areas of specialty/work
Street address
Imam Khomaini Hsp
City
Tehran
Postal code
Phone
+98 21 61190
Fax
+98 21 6119 2828
Email
sanazshaabani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)