Comparison of Premedication with Oral Clonidine and Infusion of Dexmedetomidin on Perioperative Hemodynamic Responses and Analgesic requirements Post Gynecologic Laparoscopic Surgeries
The aim of this study is to compare the hemodynamic effects and postoperative analgesia of clonidine with dexmedtomidine premedication of gynecologic laparoscopic surgeries
Design
Sixty Patients were randomly assigned to either intervention or control group using online randomization software.
Settings and conduct
Sixty ASA classes I & II patients schedule for laparoscopic procedures in operating room of Tabriz obestetric&gynecology Alzahra hospital will be divided into two groups of 30. Group one will be received Dexmedtomidine 1 µg/kg in 20 ml normal saline over 10 minute immediately before anesthesia and group two will be received oral clonidine 0.2 mg 90 minute before anesthesia . Patients of group one will be received a tablet as placebo 90 minutes before surgery and group two will be administered 20 ml normal saline as placebo over 20 minutes before induction of anesthesia.Patients hemodynamic and postoperative pain will be checked and recorded according to visual analog scale in two groups. scores higher than 4 will be treated with 0.5-1 mg/kg intravenous meperidine. The person who will evaluate the patients(outcome assessor) , will be blinded to the administered medications.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients candidate for gynecologic surgery
Exclusion criteria: patients with ASA class III or higheq
Intervention groups
Group one will be receiving 0.2 mg oral clonidine before operation.
Group two will be receiving 1 µg/kg infusion of Dexmedtomidine over 10 minute immediately before operation.
Main outcome variables
Severity of pain which will evaluated by visual analogue scale for pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120907010765N14
Registration date:2019-03-13, 1397/12/22
Registration timing:retrospective
Last update:2019-03-13, 1397/12/22
Update count:0
Registration date
2019-03-13, 1397/12/22
Registrant information
Name
Sousan Rasooli
Name of organization / entity
Alzahra hospital/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
rasoolis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center, Tabriz University of Medical Silences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Premedication with Oral Clonidine and Infusion of Dexmedetomidin on Perioperative Hemodynamic Responses and Analgesic requirements Post Gynecologic Laparoscopic Surgeries
Public title
Perioperative Hemodynamic Responses and Analgesic requirements Post Gynecologic Laparoscopic Surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients will be schedule to gynecologic laparoscopy
patients who accept for taking part in the study
patients aged 20-40
patients with ASA class I or II
Exclusion criteria:
patients with ASA class III or higher
cardiovascular disease
neurological disease
renal or hepatic disease
diabetics
addicts
Age
From 20 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
By Randomly Permuted Blocks method and using online randomization software, Patients were randomly assigned to one of the intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding of the intervention will be applied in a double-blinding procedure, such that the patients were unaware from the administered medicine and the anesthesiologists who is responsible for the induction of anesthesia will be administered the study medications to the patients ,then the outcome assessor (the one who were blinded about the administered drugs)will be evaluate patients pain and sedation score and hemodynamic status.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Scienses,Golgasht Ave,Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5157611134
Approval date
2016-07-04, 1395/04/14
Ethics committee reference number
IR.TBZMED.REC.1395.414
Health conditions studied
1
Description of health condition studied
Laparoscopic surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of Postoperative Pain
Timepoint
evaluation of the severity of postoperative pain immediately after operation( approximately 1-2 hours after drug administration related to the operation time) in recovery ,then every 30 minutes until patients transfer to the ward
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Intra and Postoperative Blood pressure
Timepoint
15 minutes after drug administration ,then every 15 minutes until patients transfer from recovery to the ward
Method of measurement
Non invasive monitoring of blood pressure with blood pressure monitor
Intervention groups
1
Description
Group one will be received infusion of 1 µg/kg Dexmedtomidine in 20 ml normal saline over 10 minute immediately before operation
Category
Treatment - Drugs
2
Description
Group two will be received an oral tablet of 0.2 mg Clonidine 90 minute before operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Obstetric and Gynecologic Hospital
Full name of responsible person
Farnaz Moslemi Tabrizi
Street address
Alzahra hospital,South Artesh ave,Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5157611134
Phone
+98 41 3329 6295
Email
moslemifa@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Dr.Ata Mahoudpour
Street address
Vice Chancellor of Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5157611134
Phone
+98 41 3553 9161
Email
moslemifa@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Vice Chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Moslemi Tabrizi
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5157611134
Phone
+98 41 3553 9161
Fax
Email
moslemifa@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vice Chancellor of Tabriz University of Medical Scienses
Full name of responsible person
Farnaz Moslemi Tabrizi
Position
Associated Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Street address
Al-Zahra Hospital, South Artesh Street
City
Tabriz
Province
East Azarbaijan
Postal code
5157611134
Phone
+98 41 3553 9161
Fax
Email
moslemifa@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Vice Chancellor of Tabriz University of Medical Sciencesr, Tabriz University of Medical Scienses
Full name of responsible person
Farnaz Moslemi Tabriz
Position
Associated professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5157611134
Phone
+98 41 3553 9161
Fax
Email
moslemifa@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Shared data/documents in this study include patients characteristics(demographic data)and those information related to the primary outcome(s). All patients private data like name.surname,file number will not be shared and completely remained closed.
When the data will become available and for how long
starting 1 year after publication.
To whom data/document is available
people working in academic institutions can be apply to receive it.
Under which criteria data/document could be used
criteria for using the information/documents including remaining them completely private and closed .They can be used only for comparison with other data and studies.
From where data/document is obtainable
the applicants can get the documents via corresponding author email address and contact with him/her.
What processes are involved for a request to access data/document
After email contact with corresponding author and Set the schedule for time(at most 2 weeks)data will be sent as a computer file to the email address of the applicant(s).