Effect of premedication with oral clonidine on hemodynamics and recovery status of patients undergoing laparoscopic cholecystectomy.
Design
120 patients that meet the inclusion criteria after surgery finished and the patient is discharged from anesthesia will be selected as research sample and then divided into intervention and control groups with binary blocking.The intervention group will receive clonidine and the control group will receive placebo. The study is a randomized, double-blind,placebo-controlled clinical trial.
Settings and conduct
Patients in operation room of Imam Reza hospital will be randomly divided into two groups according to the random number table.The intervention group received 0.5 mg clonidine and the control group will receive the same amount of placebo half an hour before surgery. Given that the study is double-blind. Both clonidine and placebo medications will be prepared each morning by the number of surgeries and number required by the plan's administrator. Envelope A contains oral clonidine and envelope B is a placebo. Each patient will receive the envelopes based on whether they are A or B coded by an anesthetist who is blinded of the type of drug.In this study patient and anesthesiologist is blinded.
Participants/Inclusion and exclusion criteria
Entry requirements:All ASA I patients aged 20-65 years who are candidate for laparoscopic cholecystectomy.
Exclusion criteria:
Blood loss over 10%
Drug addiction
Alpha-beta-blocker drugs
Patients with systemic diseases
Intervention groups
The intervention group will receive 0.2 mg clonidine orally with water and control group will receive placebo similar to first group half an hour before starting of surgery.
Main outcome variables
Evaluation of oral clonidine on hemodynamic changes such as systolic and diastolic blood pressure,MAP,heart rate,petco2 and spo2 ,pain ,shivering and nausea and vomiting.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140107016117N5
Registration date:2020-02-01, 1398/11/12
Registration timing:registered_while_recruiting
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Bahman Naghipour Basmenj
Name of organization / entity
Tabriz Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3950
Email address
naghipourb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of premedication with oral clonidine on hemodynamics and recovery status of patients undergoing laparoscopic cholecystectomy
Public title
Effect of oral clonidine on hemodynamics and recovery status of patients undergoing laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All ASA I patients aged 20-65 years who are candidate for total elective laparoscopic cholecystectomy
Exclusion criteria:
Patients with systemic diseases(cardiovascular, pulmonary, liver and kidney,...)
Blood loss over 10%
Drug addiction
Alpha-beta-blocker drugs
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study we use balanced randomization that at first four blocks with 9 combination will be formed and blocks will be numbered from 1to9. Compared to the simple randomization method, in this method the size of equilibrium of intervention and placebo groups will be established both during and at the end of study(randomization method is pre and post accidental blocks and will be done by randlist software)
Blinding (investigator's opinion)
Double blinded
Blinding description
The anesthesiologist who has responsible for the patients management of anesthesia will administer the medicine(s) via coded syringes had been prepared previously and will not aware of the injected drug(clonidine or placebo ), and anesthesia nurse who is responsible for collection of patients information and study variables and is unaware of the administered drug will record the check- list during surgery and in the recovery.Also the patient is unaware of the injected medicine.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Faculity of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-01-06, 1398/10/16
Ethics committee reference number
IR.TBZMED.REC.1398.1061
Health conditions studied
1
Description of health condition studied
The effect of oral clonidine on hemodynamic status and recovery after cholecystectomy surgery.
ICD-10 code
T88.59
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Systolic and diastolic blood pressure
Timepoint
From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery every 15 minutes until get out of recovery
Method of measurement
Mercury barometer
2
Description
Mean arterial pressure(MAP)
Timepoint
From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery every 15 minutes until get out of recovery
Method of measurement
Mercury barometer
3
Description
Heart rate
Timepoint
From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery every 15 minutes until get out of recovery
Method of measurement
Counting in each minutes
4
Description
Partial pressure of end tidal of carbondioxide
Timepoint
From the beginning of anesthesia and then every 30 minutes
Method of measurement
Using the Copnograph
5
Description
Saturation of peripheral oxygen
Timepoint
From the beginning of anesthesia and then every 30 minutes
Method of measurement
Via the Pulse Oximeter
Secondary outcomes
1
Description
pain
Timepoint
Every 15 minutes in recovery
Method of measurement
Visual analogue scale(VAS) as (0= non to 10= severe and unbearable pain)
2
Description
Severity of postoperative nausea and vomiting
Timepoint
Every 15 minutes in recovery
Method of measurement
Scoring by (0=non, 1=nausea, 2=vomiting, 3=vomiting >2 times)
3
Description
Severity of shivering
Timepoint
Every 15 minutes in recovery
Method of measurement
Observe and record the severity (shivering grade) and duration of shivering
Intervention groups
1
Description
Intervention group: The patients of this group will receive 0.2 mg clonidine orally with water .
Category
Treatment - Drugs
2
Description
Control group: this group will receive placebo similar to intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Bahman Naghipour
Street address
Department of Anesthesiology, Faculty of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
naghipourb@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Joyban
Street address
Vice chancellor for research, ِDaneshgah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tabriz University of Medical Sciences
Full name of responsible person
Bahman Naghipour
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
naghipourb@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahman Naghipour
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
naghipourb@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahman Naghipour
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Departement of Anesthesiology, Faculty of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
naghipourb@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
All collected deidentified IPD, IPD collected for the primary outcome measure are to be shared
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Documents will be available for people working in academic institutions and also people working in businesses
Under which criteria data/document could be used
There will be no specific limitations to the utilization of the data
From where data/document is obtainable
Dr .Bahman naghipour , Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran Phone+98 413 3341994 Fax+98 41 33341994 naghipourb@tbzmed.ac.ir
What processes are involved for a request to access data/document