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Evaluation of effects oral clonidine premedication on perioperative hemodynamic response and postoperative pain of patients with controlled hypertension undergoing laparoscopic cholecystectomy

Protocol summary

Summary
1) Objectives: Evaluation of effects oral clonidine premedication on perioperative hemodynamic response and postoperative pain of patients with controlled hypertension undergoing laparoscopic cholecystectomy 2) Design: in this randomized clinical trial we will assign 35 patients for each group randomly 3) Setting and Conduct: in this study, preoperatively, one group will receive oral clonidine and another group will receive oral placebo. One of our colleagues who is blinded to groups will gather and analyze the data. 4) Participants: Inclusion criteria: ASA grades II and III, both males and females, adult patients aged 18 to 65 years, with Controlled Hypertension (Systolic less than 140 and diastolic less than 90) scheduled Laparoscopic cholecystectomy surgeries. Exclusion criteria: Lack of patient consent, history of bronchial asthma, 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 (CLONIDINE HCL 0.2MG TAB, Toliddaru, Iran) preoperatively and in Placebo Group: Patients received placebo tablets in the same shape of the clonidine tablets preoperatively. 6) Main Outcome Variable: Mean arterial blood pressure during the 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: IRCT2013120111398N5
Registration date: 2014-02-16, 1392/11/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-16, 1392/11/27
Registrant information
Name
Mohammad Reza Ghodraty
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
m-ghodrati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, vice Chancellor for research affairs
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effects oral clonidine premedication on perioperative hemodynamic response and postoperative pain of patients with controlled hypertension undergoing laparoscopic cholecystectomy
Public title
The effect of clonidine on hemodynamic complications of laparoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA grades II and III, both males and females, adult patients aged 18 to 65 years, with Controlled Hypertension (Systolic less than 140 and diastolic less than 90) scheduled Laparoscopic cholecystectomy surgeries. Exclusion criteria: Lack of patient consent, history of bronchial asthma, 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
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
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
Room 501, 5th Floor, Central Office of Tehran University of Medical Sciences, Keshavarz Bolvard
City
Tehran
Postal code
Approval date
2013-06-01, 1392/03/11
Ethics committee reference number
91/dal130/3493

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

Primary outcomes

1

Description
Mean arterial blood pressure
Timepoint
Before induction, in 1,5,10,15 and 20 minute after induction, and every 15 minute until the end of the operation
Method of measurement
Will be recorded by Automatic Hemodynamic Monitoring

Secondary outcomes

1

Description
Patient's pain intensity
Timepoint
Entrance to the recovery, 30, 60, 90 and 120 minutes postoperatively
Method of measurement
According to VAS rating score

Intervention groups

1

Description
In Intervention group: Patients received 0.2 mg oral Clonidine (CLONIDINE HCL 0.2MG TAB, Toliddaru, Iran) preoperatively.
Category
Prevention

2

Description
In Placebo Group: Patients received placebo tablets in the same shape of the clonidine tablets preoperatively.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Mohammad Reza Ghodraty MD.
Street address
Department of Anesthesia, Firoozgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research deputy, Iran University of Medical Siences
Full name of responsible person
Dr Motavalian
Street address
5th floor, central bulding, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy, Iran University of Medical Siences
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
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghodraty MD.
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesia Department, Firoozgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
m-ghodrati@tums.ac.ir mrghodrati@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Ghodrati,
Position
Assistant professor of Anesthesia
Other areas of specialty/work
Street address
Anesthesia Department, Firoozgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
m-ghodrati@tums.ac.ir mrghodrati@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghodrati
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesia Department, Firoozgar Hospital, Beh-Afarin st, Karim Khan Ave,.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
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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