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The effect of low dose oral clonidine on postoperative pain in patients undergoing abdominal hysterectomy

Protocol summary

Summary
The purpose of this study is to evaluate the effects of preoperative administration of oral low dose clonidine on postoperative pain in the women undergoing general anesthesia for abdominal hysterectomy in Shahid Sadoughi hospital in Yazd, Iran. In this randomized double blind trial, 60 women, aged 40-65 years old, and ASA physical status I and II, were assigned into one of the following two groups to receive , oral clonidine 100 microgram , 2 hours before surgery, in the intervention group or placebo in the control group. Pain was assessed through visual analog scale (VAS) at 2, 6, 12, and 24 hours after the surgery.hemodynamic parameters(heart rate, systolic blood pressure)assesed before induction of anesthesia ,immediately and then 5 , 30 minutes after laryngoscopy and intubation and in the recovery room. In addition, the first request of the patient for analgesia, the amount of morphine consumed, and side effects of clonidine (dizziness,headache,pruritis) were evaluated during 24 hours and compared between groups

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108202963N3
Registration date: 2012-03-17, 1390/12/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-03-17, 1390/12/27
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2011-04-12, 1390/01/23
Expected recruitment end date
2011-10-12, 1390/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low dose oral clonidine on postoperative pain in patients undergoing abdominal hysterectomy
Public title
The effect of oral clonidine on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with American Society of Anesthesia (ASA) physical status I or II who are candidate for elective abdominal hysterectomy, age 40-65years old, BMI <35 Exclusion criteria: patients with mental impairment,chronic pain ,a history of congestive heart failure ,valvular heart disease,renal or hepatic disease,psychiatric disease ,addiction were excluded.
Age
From 40 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Shahid Sadoughi University of Medical Sciences
Street address
Bahonar square
City
Yazd
Postal code
Approval date
2011-04-12, 1390/01/23
Ethics committee reference number
38523

Health conditions studied

1

Description of health condition studied
CLONIDINE
ICD-10 code
Y52.5
ICD-10 code description
Other antihypertensive drugs, not elsewhere classified

Primary outcomes

1

Description
postoperative pain
Timepoint
2,6,12,24 hours postoperatively
Method of measurement
visual analog pain score

2

Description
the first request of the patient for analgesic
Timepoint
during 24 hours after operation
Method of measurement
in hours

3

Description
opioid consumption
Timepoint
during 24 hours after operation
Method of measurement
mg morphine

Secondary outcomes

1

Description
heart rates
Timepoint
before induction of anesthesia ,immediately and then 5 , 30 minutes after laryngoscopy and intubation and in the recovery room
Method of measurement
beats per minute

2

Description
systolic blood pressures
Timepoint
before induction of anesthesia ,immediately and then 5 , 30 minutes after laryngoscopy and intubation and in the recovery room
Method of measurement
In mnHg by Sphyngomanometer

3

Description
side effects of clonidine (headache,pruritis,dizziness)
Timepoint
1, 6, 12 and 24 hours after operation
Method of measurement
asking the patient

Intervention groups

1

Description
clonidine 100 microgram, orally 2 hours before surgery
Category
Treatment - Drugs

2

Description
placebo 2 hours before surgery
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr.Shekoufeh Behdad
Street address
Shahid Sadoughi Hospital
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Hasan Mozaffari
Street address
Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Shekoufeh Behdad
Position
Assistant of professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4104
Fax
Email
drbehdad@yahoo.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
Shekoufeh Behdad
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4104
Fax
Email
drbehdad@yahoo.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
Shekoufeh Behdad
Position
Assistant of professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
8915885967
Phone
+98 35 1822 4105
Fax
+98 35 1822 4100
Email
drbehdad@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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