The aim of this single blind clinical trial study was to compare the sedative effects of propofol and ketofol in patients undergoing CABG in ICU in Afshar Hospital. After ethics committee approval and obtaining informed consent, 45 patients 40-60 years old , ASA 1,2 devided in two groups. 30 minutes before entering the operating room, all patients received 0.1 mg / kg morphine plus 0.5 mg / kg promethazine IM. patients inducted with fentanyl 3_ 5 micro / kg , propofol 1mg / kg and Atra 0.5 mg / kg and then 3_4mg / kg / hr propofol and Atra 0.5mg / kg / hr for maintenance. At the end of the surgery patients transferred to the ICU . patient sedation was performed with propofol 15 micro / min / kg and propofol 15 micro / min / kg plus ketamine 3 micro/ min / kg in ketamin group . patient sedation was evaluated by a special algorithm ( Richmond algorithm ) with approved reliability and validity . pain score measured using Behavioral Pain Scale every two hours. After the patient extubation, delirium evaluated by ICU CAM criteria . In ICU, SBP, DBP, MAP and HR in both groups were measured and recorded, each 30 minutes at the first four hours, then each one hour after that until to extubation time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510314583N7
Registration date:2016-08-20, 1395/05/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-20, 1395/05/30
Registrant information
Name
Hossein Moshtaghion
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1525 0207
Email address
moshtaghion@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor of research of Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2016-02-19, 1394/11/30
Expected recruitment end date
2016-07-05, 1395/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison the sedative effect of propofol and ketofol on patients undergoing coronary artery bypass graft (CABG) in intensive care unit (ICU)
Public title
sedative effect of propofol and ketofol on patients undergoingcoronary artery bypass graft (CABG)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients 40-60 years old with ASA 1,2 undergoing CABG in ICU in Afshar Hospital
Exclusion criteria: patients requiring inotropic drugs; patients with impaired renal tests; addicted patients ; ejection fraction <40%; patients requiring hospitalization in the ICU for more than 24 hours; patients with known psychiatric problems; patients with history of seizure
Age
From 40 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomization was according to table of random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi university of medical sciences
Street address
Bahonar square , Yazd
City
Yazd
Postal code
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
IR.SSU.MEDICINE.REC.1394.332
Health conditions studied
1
Description of health condition studied
Ischaemic heart diseases
ICD-10 code
E120,E121,
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
pain
Timepoint
each two hours after the beginning of the process
Method of measurement
according to Behavioral Pain Scale (Questionnaire)
2
Description
heart rate
Timepoint
every 30 minutes at the first four hours and then each one hour after that until extubation
Method of measurement
by monitoring
3
Description
systolic blood pressure
Timepoint
every 30 minutes at the first four hours and then each one hour after that until extubation
Method of measurement
by monitoring
4
Description
diastolic blood pressure
Timepoint
every 30 minutes at the first four hours and then each one hour after that until extubation
Method of measurement
by monitoring
5
Description
mean arterial blood pressure
Timepoint
every 30 minutes at the first four hours and then each one hour after that until extubation
Method of measurement
by monitoring
6
Description
patient sedation
Timepoint
once
Method of measurement
by Richmond scale (Questionnaire)
Secondary outcomes
empty
Intervention groups
1
Description
intervention group 1: propofol 15 micro/kg/min once
Category
Treatment - Drugs
2
Description
intervention group 2 : propofol 15 micro/kg/min plus ketamin 3 micro/kg/min once
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital
Full name of responsible person
Dr Hossein Moshtaghion
Street address
Shahid Sadoughi hospital
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Shahid Sadoughi university of medical sciences.
Full name of responsible person
Dr Habib Nikokar
Street address
Shahid Sadoughi university of medical sciences, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Hossein Moshtaghion
Position
Assistant professor
Other areas of specialty/work
Street address
Shahid Sadoughi hospital
City
Yazd
Postal code
Phone
+98 35 3822 4000
Fax
Email
moshtaghion@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi university of medical sciences
Full name of responsible person
Dr Hossein Moshtaghion
Position
Assistant professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 3822 4000
Fax
Email
moshtaghion@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi university of medical sciences
Full name of responsible person
Dr Hossein Moshtaghion
Position
Assistant professor
Other areas of specialty/work
Street address
Shaid Sadoughi hospital
City
Yazd
Postal code
Phone
+98 35 3822 4000
Fax
Email
moshtaghion@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)