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The comparison of opioid consumption in general anesthesia and general anesthesia plus spinal anesthesia in opium addicted patient under coronary artery bypass graft surgury

Protocol summary

Summary
This study is a clinical trial on 66 patients with average age 40_75 years old, whom had history of opioid consumption that were candidated for CABG. exclusion criteria were non sinosoidal heart rythm, operation time more than 2hours, emergency operation and affected to coagulopathy. then the patients devided to 2 groups with general anesthesia only and general plus spinal anesthesia. the second group received 20 mg bupivacain0.5% plus 0.6 micro geram per kilogeram morphin that was injected interatechally. then both groups received general anesthesia in the same way, heart rate and blood pressure of the patients were controlled at the arrival time,sternotomy, intubation, pump attachement, pump dettachment and the end of operation. the mean arterial blood pressure was controlled at the range of 60_90 mm hg and heart rate at the range of 60_100 per min by some medications including beta blockers, vasodilators, vasoactive agents, opoids, sedative and cardiac stimulators that was registered.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012091910881N1
Registration date: 2013-01-16, 1391/10/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-16, 1391/10/27
Registrant information
Name
Arash Gorjizadeh
Name of organization / entity
University
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 1413
Email address
gorjizadeh.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor research- Ahvaz Jondishapur University Medical Science
Expected recruitment start date
2011-06-24, 1390/04/03
Expected recruitment end date
2012-04-22, 1391/02/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of opioid consumption in general anesthesia and general anesthesia plus spinal anesthesia in opium addicted patient under coronary artery bypass graft surgury
Public title
Opioid consumption in cardiac surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 40_75 years old age patients were candidated for CABG ; ( ASA) claass 2_3 ; History of opium abuse at least 1 time at a week for a 6 mounths period of time Exclusive criteria: Not satisfaction; Additive procedure to CABG; Lumbar disk; Infection of spinal injection site; Coagulopathy; Non sinosoidal heart rythm; Pump time more than 2hours ; Emergency surgury ; Cr clearance less than 50 ml/min
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Ahvaz Jondishapur University Medical Science
Street address
Golestan blv, Ahvaz Jondishapur University Medical Science
City
Ahvaz
Postal code
Approval date
2011-10-12, 1390/07/20
Ethics committee reference number
ETH 470

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
R.52.0
ICD-10 code description
Acute pain

Primary outcomes

1

Description
Opiod consumption
Timepoint
During and after surgery
Method of measurement
Opiod consumption base on mg and micro gram

2

Description
Pain
Timepoint
From the begining
Method of measurement
Visuai analoge scale

Secondary outcomes

1

Description
Blood pressure
Timepoint
Arrival time, Esternotomy, Intubation, Pump attachemen, pump dettachement and the end of operation
Method of measurement
ml/hg

2

Description
Heart rate
Timepoint
Arrival time, Esternotomy, Intubation, Pump attachemen, pump dettachement and the end of operation
Method of measurement
Beat per minute

Intervention groups

1

Description
General anesthesia in control group
Category
Treatment - Drugs

2

Description
In intervention group, bupivacaine 20mg single dose and morphin 0.6 mg intratechal single dose. after that general anesthesia
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr.Seyed Kamalaldin Tabatabaii
Street address
Golstan blv
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr.mostafa feghhi
Street address
Golestan blv
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Science
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
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr.Seyed Kamalaldin Tabatabaii
Position
Anesthesiologist
Other areas of specialty/work
Street address
Golestan blv
City
Ahvaz
Postal code
Phone
+61 13743001
Fax
Email
kamaleddhn tabatabaie@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr.Seyed Kamalaldin Tabatabaii
Position
Anesthesiologist
Other areas of specialty/work
Street address
Golestan blv
City
Ahvaz
Postal code
Phone
+61 13743001
Fax
Email
kamaleddin tabatabaie@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr.Arash Gorjizade
Position
Anesthesiologist
Other areas of specialty/work
Street address
Golestan blv
City
Ahvaz
Postal code
Phone
+61 13361413
Fax
Email
Arashgorjizade@ahoo.com
Web page address

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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