Protocol summary

Summary
The aim of this randomized double-blind clinical trial is to evaluate and comparison the hemodynamic changes of two regimens propofol + ketamine and thiopental Na + ketamine with etomidate during anesthesia induction. A total of 120 patients, meeting eligibility criteria, were randomly allocated into three equal groups. Inclusion criteria are informed written consent; ASA class Ι-ΙΙ; Age between 18 and 45 years; Elective surgery. Exclusion criteria are Adrenal insufficiency; Received etomidate or propofol or thiopental in one week ago; Receiving steroids at 6 months ago; Sensitivity to etomidate or propofol or thiopental; Egg and soy allergy; Sepsis; endocarditis; Chronic inflammatory diseases; Any severe disease and seriously endocrine, neurological, Psychiatric and Metabolic disorders; Pregnant or lactating women; Need for rapid intubation in emergency patients; Asthma; HIV infection; History of hypertension; Taking beta blocker, calcium blockers and angiotensin II inhibitors. After establishing routine monitors, blood pressure (systole, diastole and mean arterial pressure) and heart rate are measured and serve as baseline values. At first, all patients will receive 0.02 mg/kg midazolam and 2 µg/kg fentanyl. One minute later anesthesia induces according to the following regimen; group A: Normal saline + 0.3 mg/kg Etomidate, group B: 0.5 mg/kg Ketamine + 1.5 mg/kg Propofol, group C: 0.5 mg/kg Ketamine + 3 mg/kg thiopental Na. Immediately after the prescribed hypnotic drug, 1.5 mg/kg succinylcholine for muscle relaxation and ease of intubation will be used. 1 min after administration of hypnotic drugs just before laryngoscopy as well as 1 and 3 min after laryngoscopy and tracheal intubation, blood pressure and heart rate will be measured and compared in three groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201103114365N7
Registration date: 2011-07-10, 1390/04/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-07-10, 1390/04/19
Registrant information
Name
Afshin Gholipour Baradari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1245
Email address
gholipourafshin@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2011-07-06, 1390/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Hemodynamic Changes of two regimens propofol + ketamin and thiopental Na + ketamin with etomidate during anesthesia induction
Public title
Comparison of the Hemodynamic Changes of two regimens propofol + ketamin and thiopental Na + ketamin with etomidate during anesthesia induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Informed written consent; ASA class Ι-ΙΙ; Age between 18 and 45 years; Elective surgery Exclusion criteria: Adrenal insufficiency; Received etomidate or propofol or thiopental in one week ago; Receiving steroids at 6 months ago; Sensitivity to etomidate or propofol or thiopental; Egg and soy allergy; Sepsis; endocarditis; Chronic inflammatory diseases; Any severe disease and seriously endocrine, neurological, Psychiatric and Metabolic disorders; Pregnant or lactating women; Need for rapid intubation in emergency patients; Asthma; HIV infection; History of hypertension; Taking beta blocker, calcium blockers and angiotensin II inhibitors.
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
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 Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
46175866
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
89-185

Health conditions studied

1

Description of health condition studied
Hemodynamic Change
ICD-10 code
197.9
ICD-10 code description
Postprocedural disorder of circulatory system, unspecified

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
1 min after administration of hypnotic drugs just before laryngoscopy as well as 1 and 3 min after laryngoscopy and tracheal intubation
Method of measurement
Automated sphygmomanometer

2

Description
Diastolic blood pressure
Timepoint
1 min after administration of hypnotic drugs just before laryngoscopy as well as 1 and 3 min after laryngoscopy and tracheal intubation
Method of measurement
automated sphygmomanometer

3

Description
Mean arterial pressure
Timepoint
1 min after administration of hypnotic drugs just before laryngoscopy as well as 1 and 3 min after laryngoscopy and tracheal intubation
Method of measurement
automated sphygmomanometer

4

Description
Heart rate
Timepoint
1 min after administration of hypnotic drugs just before laryngoscopy as well as 1 and 3 min after laryngoscopy and tracheal intubation
Method of measurement
Heart monitoring

Secondary outcomes

1

Description
Delirium
Timepoint
After anesthesia
Method of measurement
Inspection

2

Description
Nausea and vomiting
Timepoint
After anesthesia
Method of measurement
Inspection

3

Description
twitching
Timepoint
After anesthetic infusion
Method of measurement
Inspection

4

Description
pain
Timepoint
After anesthetic infusion
Method of measurement
Inspection

Intervention groups

1

Description
Control group: Normal saline + 0.3 mg/kg Etomidate
Category
Treatment - Drugs

2

Description
Intervention group 1 : 0.5 mg/kg Ketamine + 1.5 mg/kg Propofol
Category
Treatment - Drugs

3

Description
Intervention group 2 : 0.5 mg/kg Ketamine + 3 mg/kg thiopental Na
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini General Hospital
Full name of responsible person
Afshin Gholipour Baradari, MD
Street address
Imam Khomeini general Hospital, Amir St.
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Mazandaran university of medical sciences, Moallem Square, Sari, Iran
City
Sari
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 of 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
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari MD
Position
CCMF, Assistant Professor, Chief of ICU
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
48175-866
Phone
+98 15132612458
Fax
+98 15 1326 2679
Email
gholipourafshin@mazums.ac.ir; gholipourafshin@yahoo.com
Web page address
www.mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari MD
Position
CCMF, Assistant Professor, Chief of ICU
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
48175-866
Phone
+98 15132612458
Fax
+98 15 1326 2679
Email
gholipourafshin@mazums.ac.ir; gholipourafshin@yahoo.com
Web page address
www.mazums.ac.ir

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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