The study of double-blind clinical trial,is done with estimating the effect of ketamine injection on the agitation after an open heart surgery.40 male patients over 55 ,referred to Golestan and Imam Khomeini’s hospital in Ahwaz,are divided into 2 groups of 20 patients and receive pre-medication with morphine 0.1mg/kg and intramuscular promethazine of 0.5 mg/kg. induction is done with diazepam 0.15 mg/kg,fentanyl 3-10 µg/kg,STP 2mg/kg,atracurium 0.5 mg/kg or atracurium 0.15 mg/kg.Anesthesia goes on with Atracurium or Cisatracurium 0.3 mg/kg and propofol 50µ/kg/min and isofluran of %0.4-%1.6. ketamine at a dose of 0.5 mg/kg is prescribed for the patients before sternotomy and before the pumping. In the second group,placebo is used(saline 0.9%) with the same size. Agitation ,during first 8 hours after the surgery is measured every 2 hours and then every 8 hours for two days with Riker Sedation-Agitation Scale (SAS).
Conditions during the study: ACT more than480; MAP :60-80 ; Heparin 300 U/kg ; heat on pump32 ºC ; cardioplegic solution Hyperkalemic 15 cc/kg intervals of 20min ;
CBP flow2.4-2.5 L/min/m2 ;PRIME solution of normal saline serum ;
Rerverse Heparin with protamine sulfate ; ABG(Pco2= 35-40 )
Inclusion criteria: Males over 55 years
Exclusion criteria CVA in past three years ; Permanent Pace maker ;
Hepatic dysfunction with ALT, AST more than 2 fold normal ; CRF( Cr more than 2) ;
Delirium week before surgery; Documented cognitive disorders ; Psychosis; Drug Abuse
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012090610762N1
Registration date:2013-03-24, 1392/01/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-24, 1392/01/04
Registrant information
Name
Anahita Babaei
Name of organization / entity
Ahwaz Jundishapur University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 61 1392 3428
Email address
babaie.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundishapur University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of interavenous Ketamine during cardiopulmonary bypass on post operative patients agitation
Public title
The effect of Ketamine on post open heart surgery patients agitation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Males over 55 years
Exclusion criteria: CVA in past three years; Permanent Pace maker ; Hepatic dysfunction with ALT, AST more than 2 fold normal ; CRF( Cr morethane2) ' Delirium week before surgery ; Documented cognitive disorders ; Psychosis ; Drug Abuse
Age
From 55 years old to 80 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jundishapur University of Medical Sciences,Vice Chancellor for Research and Technology
Street address
Vice Chancellor for Research and Technology,Jundishapur University of Medical Sciences,Esfand st, Golestan Blvd
City
Ahwaz
Postal code
Approval date
2012-06-09, 1391/03/20
Ethics committee reference number
ETH-487
Health conditions studied
1
Description of health condition studied
agitation
ICD-10 code
F43.0
ICD-10 code description
Acut stress reaction
Primary outcomes
1
Description
Post operative agitation
Timepoint
3 days after surgery (8 hours every 2 hours, then every 8 hours)
Method of measurement
SAS scale
Secondary outcomes
empty
Intervention groups
1
Description
Group 1 received intravenous ketamine 0.5 mg per kilogram of body weight before sternotomy and before the pump
Category
Treatment - Drugs
2
Description
In group 2, intravenous saline 0.5 mg per kilogram of body weight before sternotomy and before the pump
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Jundishapur University Medical Sciences
Full name of responsible person
Anahita babaei
Street address
Golestan hospital, golestan Blvd / Imam Khomeiny hospital, Azadegan street
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jundishapur University of Medical Sciences,Vice Chancellor for Research and Technology
Full name of responsible person
Dr Mostafa Feghhi
Street address
Vice Chancellor for Research and Technology ,Jundishapur University of Medical Sciences, Esfand st, Golestan Blvd
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapur University of Medical Sciences,Vice Chancellor for Research and Technology
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
Ahwaz Jundishapur University of Medical Scienses
Full name of responsible person
Anahita babaei
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Imam Khomeiny Hospital,Azadegan street
City
Ahwaz
Postal code
6193673166
Phone
+98 61 1336 7571
Fax
Email
ahmadhendinezhad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Mansour sotanzade
Position
Associate Professor
Other areas of specialty/work
Street address
Golestan hospital ,Golestan Blvd
City
Ahwaz
Postal code
6135733118
Phone
+98 61 1374 3017
Fax
Email
sultanman84@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Anahita babaei
Position
Resident of Anesthesiologu
Other areas of specialty/work
Street address
Imam Khomeiny hospital,Azadegan street
City
Ahwaz
Postal code
Phone
+98 61 1336 7571
Fax
Email
Ahmadhendinezhad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)