Protocol summary

Summary
Laryngoscopy and endotracheal intubation leads to increase in serum catecholamine level which results in hemodynamic responses such as hypertension and tachycardia and providing appropriate depth of sedation is of great importance. Dissociative Conscious Sedation (DCS) by employing subcutaneous ketamine and narcotic is a new approach, safety and usefulness of which is been proven in other invasive procedures. The aim of this study is to study the usefulness of this method in endotracheal intubation. The 48 patients are enrolled in this study. 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. Patients are divided in to two groups each including 24 cases. 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: IRCT201210209660N4
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
2012-02-01, 1390/11/12
Expected recruitment end date
2013-02-01, 1391/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between general anesthesia versus dissociative conscious sedation_ subcutaneous ketamin+ intravenous narcotics_ in hemodynamic responses to tracheal intubation in imam khomaini hospital, on 1391
Public title
A comparison between general anesthesia versus dissociative conscious sedation in hemodynamic responses to tracheal intubation.
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
2012-08-12, 1391/05/22
Ethics committee reference number
61819

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 1-3 microgram/kg fentanyl + 0.1micro/kg morphine and 1mg midazolam as premedication and 5mg/kg thiopental plus 0.6mg/kg atracurium.
Category
Treatment - Drugs

2

Description
The second group will receive 1-3microgram/kg fentanyl + 0.1micro/kg morphine and 1mg midazolam as premedication and 0.6mg/kg subcutaneous ketamine. 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. 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
Tehran University of Medical Sciences
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 Hsp
City
Tehran
Postal code
Phone
+98 21 61190
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 61190
Fax
+98 61192828
Email
sanazshaabani@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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