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Comparison the Effects of Oral Clonidine versus Oral Nifedipine on Hemodynamic Changes During Laparoscopic Cholecystectomy under General Anesthesia

Protocol summary

Summary
The aim of this study was determination and comparison the effects of oral clonidine versus oral nifedipine on hemodynamic changes during laparoscopic cholecystectomy under general anesthesia. In design of the study, 60 patients who were scheduled for elective laparoscopic cholecystectomy under general anesthesia were enrolled. The patients were divided into three equal groups randomly. Patients in the first group, received 150µg oral clonidine, in the second group, 10mg oral nifedipine and in the third group, they received vitamin C as a placebo. Method of general anesthesia was the same in the three groups. The participants of the study were patients in ASA class I-II between the age range of 20 and 60 years old. In the presence of patient refusal, systemic hypertension, congestive heart failure or aortic stenosis and also in the presence of positive history of antihypertensive, narcotic or sedative drugs consumption, patients were excluded from the study. The aim of this study was determination and comparison the effects of oral clonidine versus oral nifedipine on hemodynamic changes during laparoscopic cholecystectomy under general anesthesia. In design of the study, 60 patients who were scheduled for elective laparoscopic cholecystectomy under general anesthesia were enrolled. The patients were divided into three equal groups randomly. Patients in the first group, received 150µg oral clonidine, in the second group, 10mg oral nifedipine and in the third group, they received vitamin C as a placebo. Method of general anesthesia was the same in the three groups. The participants of the study were patients in ASA class I-II between the age range of 20 and 60 years old. In the presence of patient refusal, systemic hypertension, congestive heart failure or aortic stenosis and also in the presence of positive history of antihypertensive, narcotic or sedative drugs consumption, patients were excluded from the study. Heart rate, systolic, diastolic and mean arterial blood pressure were measured and recorded before induction of anesthesia, before surgical incision, before carbon dioxide insufflation and then every 5 minutes until 75 minutes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201305015471N1
Registration date: 2013-08-03, 1392/05/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-03, 1392/05/12
Registrant information
Name
Seyed Abbas Hosseini Jahromi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 6001
Email address
sahosseinij@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Expected recruitment start date
2012-06-11, 1391/03/22
Expected recruitment end date
2013-03-15, 1391/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effects of Oral Clonidine versus Oral Nifedipine on Hemodynamic Changes During Laparoscopic Cholecystectomy under General Anesthesia
Public title
Effects of Clonidine and Nifedipine on Hemodynamic Changes due to Laparoscopic Cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1- Laparoscopic cholecystectomy 2- Age range between 20-60 years 3- ASA class I-II Exclusion criteria 1- Positive history of systemic hypertension, congestive heart failure and aortic stenosis 2- Positive history of antihypertensive, narcotic and sedative drugs consumption 3- Patient refusal 4- Operation time more than 2 hours
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
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
Ethics Committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Approval date
2012-06-10, 1391/03/21
Ethics committee reference number
28/20/5938

Health conditions studied

1

Description of health condition studied
Cholecystitis
ICD-10 code
k80-K87
ICD-10 code description
Disorders of gallbladder and biliary tract in diseases classified elsewhere

Primary outcomes

1

Description
Blood pressure and heart rate after clonidine and nifedipine administration
Timepoint
Before induction of anesthesia, before surgical incision, before carbon dioxide insufflation and then every 5 minutes until the end of first hour of recovery period
Method of measurement
Noninvasive cardiovascular monitoring

Secondary outcomes

1

Description
Postoperative Pain
Timepoint
One hour after operation in recovery period and then for 24 hours in ward
Method of measurement
By Visual Analog Scale was determined and recorded in the questionnaire

2

Description
Shivering
Timepoint
One hour after operation in recovery period
Method of measurement
By observational method was determined and recorded in the questionnaire

3

Description
Nausea and vomiting
Timepoint
One hour after operation in recovery period
Method of measurement
By observational method was determined and recorded in the questionnaire

Intervention groups

1

Description
Patients in the first group, received 150µg oral clonidine (trademark Catapres, made in Tolid Darou Pharma Company in Iran) 30 minutes before induction of anesthesia
Category
Prevention

2

Description
Patients in the second group, received 10mg oral nifedipine (trademark Adalat, made in Tolid Darou Pharma Company in Iran) 30 minutes before induction of anesthesia
Category
Prevention

3

Description
Patients in the third group, received tablet of vitamin C (placebo) 30 minutes before induction of anesthesia
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaei Hospital
Full name of responsible person
Seyed Abbas Hosseini Jahromi M.D.
Street address
Padegan street, Shahid Rajaei Hospital
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Dr. Saeed Assefzadeh
Street address
Shahid Bahonar Blvd, Qazvin University of Medical Sciences
City
Qazvin
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 of Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Meisam Rezaei M.D.
Position
Resident in anesthesia
Other areas of specialty/work
Street address
Padegan Street, Shahid Rajaee Hospital, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1332 0107
Fax
Email
rezaei.meisam@yahoo.co.uk
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Abbas Hosseini Jahromi M.D.
Position
Anesthesiologist / Associate Professor
Other areas of specialty/work
Street address
Padegan Street, Shahid Rajaee Hospital, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1332 0107
Fax
Email
sahosseinij@qums.ac.ir papaya812002@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Masoumeh Hosseini Valami M.D.
Position
Anesthesiologist / Associate Professor
Other areas of specialty/work
Street address
Taleghani Street, Kowsar Hospital, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
smhosseiniv@qums.ac.ir parspaya872008@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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