Comparison of two methods to facilitate laryngoscopy under Anesthesia with imperfect consciousness and reginal block airway, in patients with predictable difficult airway
The purpose of this study is comparison of two methods to facilitate laryngoscopy under Anesthesia with imperfect consciousness and regional block airway, in patients with predictable difficult airway. In this study the patients aged 16 to 75 years with no history of increased intracranial pressure with predicted difficult airway will be enrolled. 60 patients referred to Tehran Imam Khomeini hospital will be divided into 2 groups, anesthesia with imperfect consciousness and regional block before surgery and factors such as recalling painful memories, compliance for laryngoscopy, patient satisfaction, changes in heart rate and blood pressure will be compared at the end of anesthesia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122112642N6
Registration date:2015-01-18, 1393/10/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-01-18, 1393/10/28
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Tehran University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods to facilitate laryngoscopy under Anesthesia with imperfect consciousness and reginal block airway, in patients with predictable difficult airway
Public title
Comparing anesthesia with imperfect consciousness and regional block in direct examination of airway
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: difficult airway; laryngeal tumor; age between 16 to 75 years
exclusion criteria: Patients with severe psychiatric disorders; known and important cardiovascular diseases; increased intracranial pressure; known intraocular pathology; previous psychotic disorder; hyperthyroidism or thyroid medication; porphyria; history of adverse reactions to ketamine
Age
From 16 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods Ave, Keshavarz Boulevard, Tehran
City
Tehran
Postal code
Approval date
2011-10-11, 1390/07/19
Ethics committee reference number
1408/ 130 /ص / 90
Health conditions studied
1
Description of health condition studied
direct laryngoscopy
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
Patient Compliance
Timepoint
During the study
Method of measurement
Expression of the patient and surgeon
2
Description
Blood pressure changes
Timepoint
Before, during and after the performing laryngoscopy
Method of measurement
according mmHg using a sphygmomanometer
Secondary outcomes
1
Description
heart rate
Timepoint
Before, during and after the performing laryngoscopy
Method of measurement
beat in minute
Intervention groups
1
Description
4-8ug/kg intra venus fentanyl and 0/6mg/kg subcutaneous ketamin
Category
Prevention
2
Description
bilateral supralaryngeal block
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Emam Khomeini Hospital
Full name of responsible person
Majid Golestani Eraghi
Street address
Kargar Ave, Keshavarz Boulevard
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Tehran University of Medical Sciences
Full name of responsible person
Masood Yoonesian
Street address
Ghods Ave, Keshavarz Boulvar, Central Organization of 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
Vice Chancellor for Research and Technology of 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr Square
City
Arak
Postal code
Phone
+98 86 3222 2003
Fax
Email
dr.golestani@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr Square
City
Arak
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)