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The effect of oral clonidine on the shoulder tip pain and hemodynamic response of patients undergoing laparoscopic surgeries

Protocol summary

Summary
1) Objectives: To study the effect of oral clonidine on hemodynamic response and shoulder tip pain of patients undergoing laparoscopic surgeries. 2) Design: In this double blind (patients and researchers) randomized clinical trial we will assign 30 patients for each group randomly 3) Setting and Conduct: In this study, one group will receive oral clonidine and another group will receive oral placebo. 4) Participants: Inclusion criteria: ASA grades II and III, males and females, adult patients aged 18 to 65 years scheduled Laparoscopic surgeries. Exclusion criteria: Lack of patient consent, history of bronchial asthma, diabetes and hypertension, patients allergic to clonidine, hypertensive and diabetic patients, severe coronary insufficiency, recent myocardial infection, concomitant use of monoamine oxidase inhibitors, tricyclic antidepressants or opioids. 5) Interventions: In intervention group: patients received 0.2 mg oral Clonidine before induction. Then, other doses of drug (0.2 mg) will prescribe after being awake and 6 hour after that and in Placebo Group: Patients received placebo tablets in the same shape of the clonidine tablets and the same times with intervention group.6) Main Outcome Variable: Mean arterial blood pressure and heart rates before prescribing Clonidine, doing induction and after operation and Patient's postoperative pain intensity were evaluated. After collecting and recording data, SPSS program will use to analyze and evaluate the differences between the two groups of patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017071117468N4
Registration date: 2017-08-16, 1396/05/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-16, 1396/05/25
Registrant information
Name
Meysam Hoseini Amiri
Name of organization / entity
Faculty of Nursing and Midwifery, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 0936
Email address
hoseiniam911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences, vice Chancellor for research affairs
Expected recruitment start date
2017-03-25, 1396/01/05
Expected recruitment end date
2017-08-06, 1396/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral clonidine on the shoulder tip pain and hemodynamic response of patients undergoing laparoscopic surgeries
Public title
The effect of clonidine on the tip shoulder pain and hemodynamic complications of laparoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA grades II and III, males and females, adult patients aged 18 to 65 years scheduled Laparoscopic surgeries. Exclusion criteria: Lack of patient consent, history of bronchial asthma, diabetes and hypertension, patients allergic to clonidine, hypertensive and diabetic patients, severe coronary insufficiency, recent myocardial infection, concomitant use of monoamine oxidase inhibitors, tricyclic antidepressants or opioids.
Age
From 18 years old to 65 years old
Gender
Both
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
Subjects will allocate to two equal groups of control and intervention using stratificaton randomization method.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Headquarters of University, Bahonar square, Yazd
City
Yazd
Postal code
Approval date
2012-01-04, 1390/10/14
Ethics committee reference number
IR.SSU.REC.1390.125789

Health conditions studied

1

Description of health condition studied
Laparoscopic cholecystectomy
ICD-10 code
K80.2
ICD-10 code description
Calculus of gallbladder without cholecystitis

2

Description of health condition studied
Laparoscopic inguinal hernia repair
ICD-10 code
K40
ICD-10 code description
Inguinal hernia

Primary outcomes

1

Description
Patient's pain intensity
Timepoint
Just after awaking, 4, 8, 12, 24 hours after operation and time of patient's discharge.
Method of measurement
According to VAS rating score

Secondary outcomes

1

Description
Heart rates
Timepoint
Just before prescribing drug and induction, 4, 8, 12, 24 hours after operation and time of patient's discharge.
Method of measurement
Will be recorded by Automatic Hemodynamic Monitoring

2

Description
Mean arterial blood pressure
Timepoint
Just before prescribing drug and induction, 4, 8, 12, 24 hours after operation and time of patient's discharge.
Method of measurement
Will be recorded by Automatic Hemodynamic Monitoring

Intervention groups

1

Description
In control group: Patients received placebo tablets in the same shape of the clonidine tablets and the same times with intervention group.
Category
Placebo

2

Description
In intervention group: Patients received 0.2 mg oral Clonidine (CLONIDINE HCL 0.4MG TAB, Toliddaru, Iran) before induction. Then, other doses of drug (0.2 mg) will prescribe after being awake and 6 hour after that.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Behshti Hospital
Full name of responsible person
Seyed Nader Mostafavi
Street address
Shahid Beheshti Blvd, Taft, Yazd
City
Taft

2

Recruitment center
Name of recruitment center
Seyyed-Al-Shohada Hospital
Full name of responsible person
Morteza Managheb
Street address
Imam St, Yazd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Yazd University of Medical Sciences
Full name of responsible person
Dr Fatemeh Ezadini
Street address
Headquarters of Medical University, Bahonar square, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr Hamid Mirhosseini
Position
PhD of neuroscience/ Faculty membership
Other areas of specialty/work
Street address
Anesthesia department, Paramedical institue, Imam Hossein square, Yazd
City
Yazd
Postal code
Phone
+98 35 3624 5956
Fax
Email
Mirhoseini.h@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Hamid Mirhosseini
Position
PhD of neuroscience/Faculty membership
Other areas of specialty/work
Street address
Anesthesia department, Paramedical institue, Imam Hossein square, Yazd
City
Yazd
Postal code
Phone
+98 35 3624 5956
Fax
Email
Mirhoseini.h@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom Medical Science University
Full name of responsible person
Meysam Hoseini Amiri
Position
MSc in nursing/ Faculty membership
Other areas of specialty/work
Street address
Qom University of Medical Sciences, Pardisan, Qom
City
Qom
Postal code
Phone
00
Fax
Email
hoseini_amiri@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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