The aim of this study is evaluating “Subcutaneous Dissociative Conscious Sedation” (sDCS) as an alternative method to airway regional blocks for awake intubation. In this prospective non-randomized study, 30 patients, with predicted difficult airway (laryngeal tumors) who were scheduled for direct laryngoscopic biopsy (DLB) in whom airway regional blocks were not possible or were unsafe, were included.” Dissociative Conscious Sedation” (DCS) exerted by intravenous fentanyl 3-4ug/kg, and subcutaneous ketamine 0.7mg/kg. The tongue and pharynx were anaesthetized with lidocaine spray (4%). 8-10 minutes after subcutaneous injection of ketamine direct laryngoscopy was performed. Extra doses of fentanyl 50-100 ug was administered if the patient wasn't cooperative enough for laryngoscopy. The patients were evaluated for hemodynamic stability (heart rate and blood pressure), oxygen saturation (Spo2), patient’s cooperation (obedient to open the mouth for laryngoscopy) and the number of tries for laryngoscopy, patient’s comfort (remaining moveless), hallucination, nystagmus and salivation (need for aspiration before laryngoscopy) during the laryngoscopy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012075333N1
Registration date:2011-08-29, 1390/06/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-29, 1390/06/07
Registrant information
Name
Mihan Jafari Javid
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2329
Email address
jafarija@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-12-01, 1388/09/10
Expected recruitment end date
2010-02-01, 1388/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dissociative conscious sedation an alternative to regional airway blocks
Public title
An alternative method for regional airway blocks
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: predicted difficult airway because of laryngeal tumors with impossible airway regional blocks
Exclusion criteria: history of Psychological disorders, coronary artery disease, uncontrolled hypertension, increased ICP, intracranial mass lesions, open eye injury
Age
From 40 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Dean for Research, Faculty of medicine
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2011-07-30, 1390/05/08
Ethics committee reference number
13918
Health conditions studied
1
Description of health condition studied
difficult laryngoscopy and difficult intubation
ICD-10 code
Y40, y84
ICD-10 code description
Complications of medical and surgical care
Primary outcomes
1
Description
possibility of laryngoscopy
Timepoint
time of intubation
Method of measurement
successful or not successful
2
Description
possibility of fiberoptic bronchoscopy
Timepoint
time of intubation
Method of measurement
successful or not successful
3
Description
possibility of rigid bronchoscopy
Timepoint
no time point
Method of measurement
successful or not successful
4
Description
Possibility of Double lumen endobronchial intubation
Timepoint
Evaluation of possibility of endobronchial intubation
Method of measurement
possibility of procedure
Secondary outcomes
1
Description
hemodynamic changes
Timepoint
3-4 times during the procedure
Method of measurement
increased heart rate and blood pressure
2
Description
Spo2
Timepoint
continuous
Method of measurement
Pulseoximetry
3
Description
Patient's cooperation
Timepoint
during the procedure
Method of measurement
Possibility of tube insertion
Intervention groups
1
Description
1-Subcutaneous Ketamine 0.7mg/kg
2- intravenous Fentanyl 2-4 ug/kg
3- Anesthesia of the tongue, larynx and pharynx with lidocain spray 4%
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomaini Medical center
Full name of responsible person
Mihan Jafari Javid
Street address
Tehran University of Medical Sciences
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of Medical Scioences
Full name of responsible person
Shahin Akhondzadeh
Street address
Vice-chancellor for Research, Faculty of Medicine, Tehran University of Medical Sciences
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 Scioences
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
Mihan Jafari Javid
Position
Associate Professor
Other areas of specialty/work
Street address
Department of anesthesiology, Imam Khomaini Medical center, Tehran , Iran
City
Tehran
Postal code
Phone
+98 21 6119 2329
Fax
+98 21 6119 2329
Email
jafarija@sina.ac.irmihanjavid@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
Mihan Jafari javid
Position
Associate professor
Other areas of specialty/work
Street address
Department of anesthesiology, Imam Khomaini Medical center, Tehran, Iran
City
Tehran
Postal code
Phone
+98 212161192329
Fax
+98 21 6119 2329
Email
jafarija@sina.tums.ac.ir 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
Mihan Jafari Javid
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Anesthesiology, Imam Khomaini Medical center, Tehran , Iran
City
Tehran
Postal code
Phone
+98 21 6119 2329
Fax
+98 21 6119 2329
Email
jafarija@sina.tums.ac.irmihanjavid@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)