The aim of this randomized double-blind clinical trial is to evaluate Laryngoscopy and tracheal intubating condition after co-induction with propofol plus lidocaine and different doses of remifentanil in the absence of muscle relaxant drugs. A total of 162 patients, meeting eligibility criteria, were randomly allocated into two equal groups. After establishing routine monitors, blood pressure and heart rate are measured and serve as baseline values. All patients after hydration and premedication with 0.02 mg/kg midazolam will receive 1.5 mg/kg lidocaine, 2 mg/kg propofol and according to the group 2 or 3 µg/kg remifentanil. 90 seconds after induction of anesthesia, laryngoscopy and intubation was performed. Laryngoscopy and intubation conditions on the movement and position of vocal cord, airway reaction and limb movement as excellent, good and poor will be assessed. Immediately and 5 min after laryngoscopy and tracheal intubation, blood pressure and heart rate will be measured. Finally Laryngoscopy and intubation conditions and blood pressure and heart rate are compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110216803N2
Registration date:2011-10-27, 1390/08/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-27, 1390/08/05
Registrant information
Name
Abolfazl Firouzian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 6655
Email address
a.firouzian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2006-09-23, 1385/07/01
Expected recruitment end date
2007-02-20, 1385/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of different doses of remifentanil on tracheal intubation in the absence of muscle relaxants
Public title
The effect of remifentanil on endotracheal intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Informed written consent; ASA class Ι-ΙΙ; Age between 18 and 50 years; Elective surgery; Mallampati class Ι-ΙΙ.
Exclusion criteria: History of difficult intubation; Pulmonary diseases; Recent respiratory tract infection; History of previous surgery on the larynx; Smoking; Gastroesophageal reflux; Hiatal hernia; Substance abuse; Pregnancy; Obesity; Renal diseases (baseline serum creatinine > 2mg/dl); Hepatic diseases (liver function tests > 1.5 times of the normal upper limit).
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
162
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
Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
46175866
Approval date
2006-09-13, 1385/06/22
Ethics committee reference number
63-85
Health conditions studied
1
Description of health condition studied
In the absence of muscle relaxants to facilitate intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
tracheal intubation
Timepoint
90 seconds after induction of anesthesia
Method of measurement
on the movement and position of vocal cord, airway reaction and limb movement as excellent, good and poor will be assessed.
Secondary outcomes
1
Description
systolic pressure
Timepoint
Immediately and 5 min after laryngoscopy and tracheal intubation
Method of measurement
manometer
2
Description
diastolic pressure
Timepoint
Immediately and 5 min after laryngoscopy and tracheal intubation
Method of measurement
manometer
3
Description
heart rate
Timepoint
Immediately and 5 min after laryngoscopy and tracheal intubation
Method of measurement
manitoring
Intervention groups
1
Description
intervention 1: Remifentanil 2 µg/kg
Category
Treatment - Drugs
2
Description
intervention 2 : Remifentanil 3 µg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeini hospital
Full name of responsible person
Alieh Zamani Kiasary MD,Assistant Professor
Street address
Emam khomeini hospitalو Amirmazandarani Ave.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Alieh Zamani Kiasary MD
Position
Anesthesiologist,Assistant Professor
Other areas of specialty/work
Street address
Amirmazandarani Ave- Emam khomeini hospital
City
Sari
Postal code
4814839953
Phone
+98 15 1222 4488
Fax
+98 15 1227 5038
Email
aliehzamani@yahoo.com
Web page address
www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian
Position
Anesthesiologist
Other areas of specialty/work
Street address
Amirmazandarani Ave- Emam khomeini hospital
City
Sari
Postal code
4814839953
Phone
+98 15 1222 6655
Fax
+98 15 1227 5038
Email
a.firouzian@mazums.ac.ir
Web page address
www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)