Protocol summary

Summary
Due to importance of early extubation of patients within 6 to8 hours after arrival to ICU and shortening the length of their stay in ICU, which is called fast tract recovery, we try to compare the effects of bolous and maintenance dose of neuromuscular blocker atracurium in fast tract recovery and early extubation of patients and their probable movement during surgery in single bolous dose,hich interfere with the surgeon field, undergoing open heart Coronary Artery By pass Graft surgery and come in to conclusion if maintenance dose is necessary. Inclusion criteria: 18-75 years old patients planned to go under elective coronary artery bypass graft. Exclusion criteria: myopathy, neuropathy, severe renal and pulmonary disease, emergency surgeries and opium addiction. One hundred patients were evaluated in two different single blinded randomized groups; group B used bolus dose of atracurium and group M treated with maintenance doses of Atracurium. The study groups were compared by demographic, hemodynamic, fast-track and extubation time and ICU admission time.

General information

Acronym
CABG:coronary artery bypass
IRCT registration information
IRCT registration number: IRCT201012295496N1
Registration date: 2012-01-01, 1390/10/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-01-01, 1390/10/11
Registrant information
Name
Ata Garajei
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 0673
Email address
atagarajei@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Univercity of Medical Sciences ,vice chancellor for research
Expected recruitment start date
2011-01-01, 1389/10/11
Expected recruitment end date
2011-06-01, 1390/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effects of not using maintnance dose o atracurium dring open hear sugery in Coronary Artery Bypass Graft patiants
Public title
Assessing the effects of not using maintnance dose of atracurium during open heart sugery in Coronary Artery Bypass Graft patiants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: 18-75y old patients planned to go under Coronary Artery Bypass Graft surgery. Exclusion criteria: myopathy; neuropathy; sever pulmonary or renal disease; emergency surgery and opium addiction
Age
From 18 years old to 75 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran University of Medical Sciences
Street address
Next to Milad Hospital, Hemat highway
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
42120

Health conditions studied

1

Description of health condition studied
Coronary artery bypass graft
ICD-10 code
T82
ICD-10 code description
Complications of cardiac and vascular prosthetic devices, implants and grafts

Primary outcomes

1

Description
Extubation time
Timepoint
6 to 8 hours after surgery
Method of measurement
Extubation criteria as Acid blood gass

2

Description
Probable patiants movement during surgery
Timepoint
During surgery
Method of measurement
Visual and Train of four

Secondary outcomes

1

Description
Paralysis time
Timepoint
6 to 8 hours after sugery
Method of measurement
Hours

2

Description
ICU staying lenghth
Timepoint
6 to 8 hours after surgery
Method of measurement
Hours

Intervention groups

1

Description
Control group: received both intubation bolous dose of atracurium and maintenance dose of atracurium
Category
Prevention

2

Description
Intervention group: received bolous dose of atracuium just at intubation time
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaiee Heart Hospital Center
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice chancellor for research
Street address
vice chancellor for research, Tehran University of Medical Sciences, Keshavarz bulvd, Ghods Ave,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran Univercity of Medical Sciences
Full name of responsible person
Azadeh Emami
Position
MD
Other areas of specialty/work
Street address
Rasool Akram hospital
City
Tehran
Postal code
Phone
+98 21 2237 0673
Fax
Email
azi_emami@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran Univercity of Medical Sciences
Full name of responsible person
Azadeh Emami
Position
MD
Other areas of specialty/work
Street address
Rasool Akram hospital
City
Tehran
Postal code
Phone
+98 21 2237 0673
Fax
Email
azi_emami@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Emami
Position
MD
Other areas of specialty/work
Street address
Rasool Akram hospital
City
Tehran
Postal code
Phone
+98 21 2237 0673
Fax
Email
azi_emami@yahoo.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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