1. Home
  2. Approved trials
  3. » فارسی

The Effects of Pregabalin on Agitation and Pain after Coronary Artery Bypass Graft Surgery

Protocol summary

Summary
Objectives: The aim of this study was to investigate the effects of pregabalin on the agitation and pain after coronary artery bypass graft surgery. Design of the study: randomized double blind clinical trial. Inclusion criteria: Patients who undergo coronary artery bypass graft surgery. exclusion criteria: EF < 35%, Cr > 1.5, BMI > 35, chronic alcohol consumers, drug addicts, epileptic patients, patients with insulin dependent diabetes mellitus ', recent use of gabapentin, uncontrolled blood pressure, liver failure, the sensitivity of the Pregabalin, return to the operating room during the study period, the patient's re-intubation during the first 3 days after the surgery, mortality during the first 3 days. Sample Size: 94 patients found eligible based on the inclusion criteria. Patients were randomly divided into two groups of intervention group and placebo group. Patients in the intervention group received 150 mg pregabalin, 2 hours before surgery and 75 mg pregabalin at the first, second and third days after surgery in the hours of 9 am and 9 pm and patients in the placebo group received one capsule placebo at the same time. The written forms of VAS and RASS were completed at 11 am and 11 pm. On the other hand, the amount of other analgesic drugs was considered in the study in addition to the pregabalin for controlling pain and agitation in the intensive care unit.

General information

Acronym
RASS (Richmond agitation sedation scale),VAS(Visual analogue scale)
IRCT registration information
IRCT registration number: IRCT2014101719470N2
Registration date: 2015-01-16, 1393/10/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-01-16, 1393/10/26
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Science
Expected recruitment start date
2015-02-01, 1393/11/12
Expected recruitment end date
2015-03-06, 1393/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Pregabalin on Agitation and Pain after Coronary Artery Bypass Graft Surgery
Public title
The Effects of Pregabalin on Agitation and Pain after Cardiac Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who undergo coronary artery bypass graft surgery. exclusion criteria: EF < 35%, Cr > 1.5, BMI > 35, chronic alcohol consumers, drug addicts, epileptic patients, patients with insulin dependent diabetes mellitus ', recent use of gabapentin, uncontrolled blood pressure, liver failure, the sensitivity of the Pregabalin, return to the operating room during the study period, the patient's re-intubation during the first 3 days after the surgery, mortality during the first 3 days.
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University Of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
CP-P-9364-6444

Health conditions studied

1

Description of health condition studied
Coronary Artery Bypass Graft
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic Heart Disease

Primary outcomes

1

Description
Pain
Timepoint
Twice at Three Days after Surgery
Method of measurement
,VAS(Visual Analogue Scale

Secondary outcomes

1

Description
Agitation
Timepoint
Twice at Three Days after Surgery
Method of measurement
Richmond agitation sedation scale

Intervention groups

1

Description
Patients in the intervention group received 150 mg pregabalin, 2 hours before surgery and 75 mg pregabalin at the first, second and third days after surgery in the hours of 9 am and 9 pm .
Category
Treatment - Drugs

2

Description
Patients in the control group received one capsule placebo , 2 hours before surgery and at the first, second and third days after surgery in the hours of 9 am and 9 pm
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Sudabeh Emami
Street address
Anesthesiology Office, Namazi Hospital, Zand Street
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed BasirHashemi
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sudabeh Emami
Position
Physician, Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3235 7282
Fax
Email
emami_s@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Reza Jouybar
Position
Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology office, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
joybarr@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
Other areas of specialty/work
Street address
Anesthesiology Department ,Faghihi Hospital ,Zand Street
City
Shiraz
Postal code
Phone
00
Fax
Email
masihifarzaneh@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
Loading...