Comparing the effects of three different additional doses of propofol infusion on intubation condition and hemodynamic changes during general anesthesia under elective surgery
Laryngoscopy and endotracheal intubation can induce unfavorable hemodynamic changes as propofol itself can induce hypotension. The aim of this study was to compare the effects of three different additional doses of propofol infusion on intubation conditions and hemodynamic changes occurred after intubation.
This double-blinded prospective study was performed on 140 patients aged 18-60 who received different additional doses of propofol and were randomly allocated into 4 groups as follows: A: received additional dose of propofol 0.5 mg/kg infused after an initial dose 1.5 mg/kg .B: received additional dose of propofol 1mg/kg infused after an initial dose 1mg/kg. C:received additional dose of propofol 1.5 mg/kg after an initial dose 1mg/kg. D:received propofol 2mg/kg as a bolus with no additional dose.Heart rate and mean arterial pressure were examined and recorded at preinduction, immediately prior to laryngoscopy, one , three ,five and ten minutes after laryngoscopy.Intubation conditions were examined and categorized by Magorian et al.scoring system .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307145362N6
Registration date:2013-08-01, 1392/05/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-01, 1392/05/10
Registrant information
Name
Mohammadreza Safavi
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1273 2659
Email address
safavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of three different additional doses of propofol infusion on intubation condition and hemodynamic changes during general anesthesia under elective surgery
Public title
Comparing the effects of three different additional doses of propofol infusion on intubation condition and hemodynamic changes during general anesthesia under elective surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: American Society of Anesthesiologists (ASA) physical status ǀ and ǁ patients ; aged 18 to 60 years ; with normal airway; Body Mass Index less than 27.5 kg/m2 and more than 18.5 kg/m2 .
Exclusion criteria : sensitivity to protocol ; anesthesia with techniques, different from the protocol of this study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Isfahan,Iran
City
Isfahan
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
390172
Health conditions studied
1
Description of health condition studied
complications of tracheal intubation
ICD-10 code
T88.4
ICD-10 code description
failed or difficult intubation
Primary outcomes
1
Description
Intubation conditions
Timepoint
at the time of intubation
Method of measurement
Magorian et al scoring system
2
Description
hemodynamic changes
Timepoint
at preinduction, immediately prior to laryngoscopy, one , three ,five and ten minutes after laryngoscopy
Method of measurement
blood pressure (mmHg) and pulse(bpm) measured by heart monitoring divice
Secondary outcomes
1
Description
bronchospasm,laryngospasmand cyanosis
Timepoint
after laryngoscopy and intubation
Method of measurement
observation
Intervention groups
1
Description
Group A received additional dose of propofol 0.5 mg/kg infused after an initial dose 1.5 mg/kg .additional dose of propofol was infused within 90 seconds by infusion pump.
Category
Prevention
2
Description
Group B received additional dose of propofol 1mg/kg infused after an initial dose 1mg/kg. additional dose of propofol was infused within 90 seconds by infusion pump.
Category
Prevention
3
Description
Group C received additional dose of propofol 1.5 mg/kg after an initial dose 1mg/kg.
additional dose of propofol was infused within 90 seconds by infusion pump.
Category
Prevention
4
Description
Group D received propofol 2mg/kg as a bolus with no additional dose.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, I
Full name of responsible person
Mohammadreza Safavi ,MD
Street address
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Peyman Adibi ,MD
Street address
Anesthesiology and Critical Care Research Center , Isfahan University of Medical Sciences, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Anesthesiology and Critical Care Research Center, Isfahan 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
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Safavi,MD
Position
Associate professor of anesthesia
Other areas of specialty/work
Street address
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 311625555
Fax
Email
safavi@med.mui.ac.ir; honarmand@med.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand,MD
Position
Asssociate professor of anesthesia
Other areas of specialty/work
Street address
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 913 110 2327
Fax
Email
honarmand@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology and Critical Care Research Center,Isfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Safavi, MD
Position
Associate professor of anesthesia
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Ifahan
Postal code
Phone
00
Fax
Email
safavi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)