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Evaluation of effectiveness of Gabapentin in lowering pain and Pethidine consumption in patients undergoing septal deviation surgery

Protocol summary

Summary
Our study was aimed to test the effect of Gabapentin on lowering the postoperative pain and Pethidine consumption in septal deviation surgery . In this present study, A prospective, , double- blind, randomized study along with 62 patients 18- 40 year was designed as treatment and control groups . Inclusion criteria: ASA class I ; min age18 ; max age 40; min weight 40kg ; Exclusion criteria : allergy to Gabapentin ; epilepsy ; and previous treatment with Gabapentin ; a chronic pain syndrome; a history of cardiovascular; respiratory ; renal or hepatic disease ; psychiatric disorders; substance abuse 31 treatment group received 800 miligram Gabapentin one hour before surgery and 31 control group received placebo one hour before surgery. General anesthesia was induced at both similarly. An experienced anesthesiologist intubated all the enrolled patients. They were then extubated in the operating room and transferred to the post anesthesia care unit . pain score by Visual Analogue Scale , respiratory rate , heart rate , mean arterial blood pressure at the time of 1, 4, 8, 12, 16, 20 and 24 h after anesthesia and Pethidine consumption in 24 hours were collected postoperatively. MAP and HR before anesthesia induction and 1,3,5,10,15 min after intubation were measured

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012080510509N1
Registration date: 2012-10-17, 1391/07/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-10-17, 1391/07/26
Registrant information
Name
Sholeh Nesioonpour
Name of organization / entity
Ahvaz Jundishapur Medical University
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0168
Email address
nesioonpour-sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz JundiShapur University of Medical Sciences , Research and Technology Center
Expected recruitment start date
2009-12-22, 1388/10/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of Gabapentin in lowering pain and Pethidine consumption in patients undergoing septal deviation surgery
Public title
Analgesic effect of Gabapentin after septal deviation surgeury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : ASAclass I ; min age18 ; max age 40 ; min weight 40kg; Exclusion criteria : allergy to Gabapentin ; epilepsy ; and previous treatment with Gabapentin ; a chronic pain syndrome ; a history of cardiovascular ; respiratory ; renal or hepatic disease ; psychiatric disorders ; substance abuse
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
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
Ahwaz JundiShapur University of Medical Sciences
Street address
Shahrak Daneshgah , Golestan
City
Ahvaz
Postal code
Approval date
2009-11-14, 1388/08/23
Ethics committee reference number
8/20/1462/پ

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
Acute Pain

Primary outcomes

1

Description
Pain
Timepoint
1,4,8,12,16,20,24 hour after surgery
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Pethidine Consumption
Timepoint
24 hour after surgery
Method of measurement
Milligram

Intervention groups

1

Description
Treatment group received 800 milligram Gabapentin one hour before surgery
Category
Treatment - Drugs

2

Description
Control group received placebo one hour before surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Sholeh Nesioonpour
Street address
Azadegan avenue
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology Center, Ahvaz JundiShapur University of Medical Sciences
Full name of responsible person
Dr Mostafa Feghhi
Street address
Shahrak Daneshgah , Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Center, Ahvaz JundiShapur 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
School of Medicine , JundiShapur University of Medical Sciences
Full name of responsible person
Dr Sholeh Nesioonpour
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Azadegan Avenue , Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
nesioonpour-sh@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Medicine , Ahvaz JundiShapur University of Medical Sciences
Full name of responsible person
Dr Sholeh Nesioonpour
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Azadegan avenue , Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
nesioonpour-sh@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Medicine , Ahvaz JundiShapur University of Medical Sciences
Full name of responsible person
Dr Sholeh Nesioonpour
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Azadegan avenue , Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
nesioonpour@ajums.ac.ir
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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