Background and Objective: After induction of anesthesia, tracheal intubation is commonly facilitated by the use of muscle relaxants. Recent studies have suggested that propofol in combination with short-acting opioid such as alfentanil and remifentanil may provide adequate conditions for laryngoscopy and tracheal intubation without using muscle relaxants. In this study, we compare intubating conditions and cardiovascular changes following induction of anesthesia and tracheal intubation in patients receiving either propofol-remifentanil or propofol-succynylcholineto induction. Design: Single blind clinical trial. Setting: Patients were divided into two groups randomly: succynylcholin and remifentanil. Midazolam 0.05 mg.kg and lidocaine 1.5 mg.kg iv was given as premedication approximately 5 minutes before induction of anesthesia. All patients were prehydrated with ringer 5cc.kg before induction.Inclusion criteria: Sixty ASA 1 and2 children aged between 3 and 12 years who require tracheal intubation for elective surgery Exclusion Criteria: Children with common cold; cardiorespiratory disease; neuromascular disease; difficult intubation; other systemic disease Intervention:Control group, propofol(3 mg.kg) was first administrated ovrer10 s followed by succinylcoline(1.5mg.kg) as a rapid bolus. In study group, propofol was followed by remifentanil(2mic.kg) given as a slow blous infusion over 30 sec. Main outcomes: Intubation conditions were assessed as excellent, good or poor on the basis of jaw relaxation, vocal cords, bucking, coughing or body movements.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209089874N2
Registration date:2013-08-11, 1392/05/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-11, 1392/05/20
Registrant information
Name
Freshteh Naziri
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
freshteh.naziri@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor Of Research Babol University Of Medical Science
Expected recruitment start date
2012-06-14, 1391/03/25
Expected recruitment end date
2013-03-15, 1391/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of tracheal intubation with propofol - remifentanil and propofol – succynylcholine in children 3 -12 years
Public title
Comparison of tracheal intubation with propofol - remifentanil and propofol – succynylcholine in children 3 -12 years
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion Criteria:Children aged between 3-12 who undergoing elective surgery.
Exclusion Criteria:Children with common cold; cardiorespiratory disease; nuromuscular disease; difficult intubation; other systemic disease
Age
From 3 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Approval date
2013-03-09, 1391/12/19
Ethics committee reference number
2159/30/ژ/پ
Health conditions studied
1
Description of health condition studied
General Anesthesia
ICD-10 code
T88.8
ICD-10 code description
Other complications of surgical and medical care, not elsewhere classified
Primary outcomes
1
Description
Determination of tracheal intubation condition in children without muscle relaxant with propofol-remifentanil
Timepoint
5 minutes before and after intubation
Method of measurement
Direct observation
Secondary outcomes
1
Description
Comparing pulse rate and blood pressure in two groups
Timepoint
5 minutes before and after intubation
Method of measurement
BP manometer, ECG
2
Description
Comparing laryngoscopy condition between two groups
Timepoint
During Laryngoscopy
Method of measurement
Direct observation
3
Description
Comparing cough between two groups
Timepoint
During and after intubation
Method of measurement
Direct observation
4
Description
Comparing movement of limbers between two groups
Timepoint
During and after intubation
Method of measurement
Direct observation
Intervention groups
1
Description
The intervention group, 3mg/kg propofol injection was used in 10 seconds, then 2microg/kg remifentanil injection is used in 30 seconds finally after 60 seconds, laryngoscopy and intubation are performed.
Category
Diagnosis
2
Description
The control group, 3mg/kg propofol injection is used for 10 seconds, succynylcoline injection with 1.5mg/kg, after 50 seconds injected after 40 seconds, laryngoscopy and intubation are performed.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Ruhani Hospital
Full name of responsible person
Dr Freshteh Naziri
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
2
Recruitment center
Name of recruitment center
shahid Beheshti Hospital
Full name of responsible person
Dr Freshteh Naziri
Street address
shahid ghasemi Avenue
City
Babol
3
Recruitment center
Name of recruitment center
Amirkola pediatric hospital
Full name of responsible person
Dr Freshteh Naziri
Street address
Emam 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 Freshteh Naziri
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
freshteh.naziri@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
Dr Freshteh Naziri
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
freshteh.naziri@yahoo.com, ans_dep@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Freshteh Naziri
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
00
Fax
Email
freshteh.naziri@yahoo.com, ans_dep@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)