Background & Purpose: Using muscle relaxants for endotracheal intubation is not always possible, therefore we can use short-acting opioids along with propofol. Design: double-blind clinical trial method: patients are allocated randomly into 2 30-person groups. The doctor and the patients were unaware of the injected dose of the drug. Inclusion criteri: 60 patients aged between 18-35; orthopedic operation; ASA class I,II exclusion criteria: hypertention; cardiovascular problems; difficult and irritant air-way; drug abuse; BMI above 30 interventions: after initial assessment and standard monitoring, 10cc/Kg Ringer’s solution is infused. 0.03mg/Kg midazolam and 1mg/Kg meperidine is administered to all of them. After 5 minutes, 1µg/Kg and 1.5µg/Kg remifentanyl is administered to the first and the second group, respectively. Moreover, 2mg/Kg propofol is infused over 60 seconds for both groups. Primary consequences : changes in patient’s blood pressure and heart rate in specific time intervals are recorded
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310234923N4
Registration date:2013-12-12, 1392/09/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-12, 1392/09/21
Registrant information
Name
Bahman Hasannasab
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
bahmanh2002@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor Of Research Babol University Of Medical Sciences
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of different doses of remifentanyl with the combination of propofol and meperidine on endotracheal intubation without muscle relaxant
Public title
comparison of different doses of remifentanyl with the combination of propofol and meperidine on endotracheal intubation without muscle relaxant
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : patients aged between 18-35 , ASA؛ class I and II , general anesthesia ,undergoing orthopedic surgery
exclusion criteria : The patients with hypertention, cardiovascular problems, irritable air way, drug abuse, BMI above 30, addiction and possibility of difficult airway
Age
From 18 years old to 35 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
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Approval date
2009-07-04, 1388/04/13
Ethics committee reference number
3823/30/ژ/پ
Health conditions studied
1
Description of health condition studied
endotracheal intubation
ICD-10 code
Y45.0
ICD-10 code description
Opioids and related analgesics
Primary outcomes
1
Description
endotracheal intubation
Timepoint
60 seconds after drug injection
Method of measurement
evaluation of jaw relaxation ; laryngoscopy status ,vocal cord ,and coughing
Secondary outcomes
1
Description
blood pressure
Timepoint
before intubation, after drug injection, in one, three and five minutes after endotracheal intubation.
Method of measurement
cuff manometer
2
Description
heart rate
Timepoint
before intubation, after drug injection, in one, three and five minutes after endotracheal intubation.
Method of measurement
, puls oximetry
Intervention groups
1
Description
1µg/Kg remifentanil injection
Category
Treatment - Drugs
2
Description
1.5µg/Kg remifentanil injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti Hospital
Full name of responsible person
Dr Bahman Hasannasab
Street address
Shahid Ghasemi Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor Of Research Babol University Of Medical Sciences
Full name of responsible person
Dr Amrolah Mostafazadeh
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor Of Research Babol 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
Babol University Of Medical Sciences
Full name of responsible person
Dr Bahman Hasannasab
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
bahmanh2002@yahoo.com; ans_dep@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
1-Dr Bahman Hasannasab , 2-Dr mohmmad ali ropani
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
bahmanh2002@yahoo.com; ans_dep@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)