A comparative study on the prophylactic effect of Dexmedetomidine and Paracetamol on intraoperative hemodynamic control and postoperative pain in patients undergoing laparoscopic cholecystectomy
Comparison of prophylactic effect of Dexmedetomidine and Paracetamol on hemodynamic control during surgery and post operative pain in patients with laparoscopic cholecystectomy
Design
Two arm parallel group randomized trial
Settings and conduct
132 patients are divided into two groups of 66 people.
Patients admitted to the Amiralmomenin Hospital of Arak are under study.
In each group, hemodynamic therapy is measured before surgery, 30, 60, and 90 minutes postoperatively.
Postoperative pain is measured by Visual Analogue Scale in recovery, 4, 12, and 24 hours postoperatively.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1: Patients from 18 to 70 years old
2: Both genders
3: Patients who are indicated for urgent or elective Laparoscopic Cholecystectomy
4: Acquiring the informed consent of participating in a clinical study
Exclusion criteria:
1: Conversion from Laparoscopic to open surgery
2: Partial Cholecystectomy
3: Gangrenous Gall Bladder
4: Abscess
5: Trauma to major Bile ducts
Intervention groups
The Dexmedmotidine group, in which patients receive Dexmedetomidine before and after the onset of action.
The Paracetamol group in which patients receive Paracetamol before and 6 hours to 24 hours.
Main outcome variables
Operative hemodynamics in which the MAP and heart rate are measured.
Postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180115038381N1
Registration date:2019-02-18, 1397/11/29
Registration timing:retrospective
Last update:2019-02-18, 1397/11/29
Update count:0
Registration date
2019-02-18, 1397/11/29
Registrant information
Name
Taha Hojjati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3223 1102
Email address
taha.hojjati@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-04-04, 1396/01/15
Actual recruitment end date
2017-11-22, 1396/09/01
Trial completion date
2017-12-22, 1396/10/01
Scientific title
A comparative study on the prophylactic effect of Dexmedetomidine and Paracetamol on intraoperative hemodynamic control and postoperative pain in patients undergoing laparoscopic cholecystectomy
Public title
A comparative study on the prophylactic effect of Dexmedetomidine and Paracetamol on intraoperative hemodynamic control and postoperative pain in patients undergoing laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are indicated for emergency or elective Laparoscopic Cholecystectomy.
Obtaining informed consent
Both genders
Patients between 18 to 70 years old
Exclusion criteria:
Conversion of Laparoscopic surgery to open surgery
Partial Cholecystectomy
Gangrenous Gall bladder
Abscess
Major trauma to Bile ducts
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
132
Actual sample size reached:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked Randomization
Individual random unit
Randomization tool under web (www.randomizer.org)
Randomization sequence was made under web (www.radomizer.org)
Hiding: Sealed envelope
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Deputy Director of Research and Technology, University of Medical Sciences campus site, Basij Square, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2017-05-01, 1396/02/11
Ethics committee reference number
IR.ARAKMU.REC.1396.1
Health conditions studied
1
Description of health condition studied
Postoperative pain after Laparoscopic Cholecystectom
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Peri-operative Hemodynamic
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean Arterial Blood Pressure
Timepoint
Immediately after Anesthesia induction, 30 minutes after surgery, 1 hour after surgery, 90 minutes after surgery
Method of measurement
Blood pressure gauge
2
Description
Pulse Rate
Timepoint
Immediately after Anesthesia induction, 30 minutes after surgery, 1 hour after surgery, 90 minutes after surgery
Method of measurement
Measured by the questioner
3
Description
Postoperative Pain
Timepoint
In Recovery Unit, 4 hour after surgery, 12 hour after surgery, 24 hour after surgery
Method of measurement
With Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group included 66 patients undergoing laparoscopic cholecystectomy and receiving doxedemotomidine. Patients in this group receive 1 μg / Kg stat and then 0.5 μg / Kg per hour. In this study, the American Percedex product, each vial containing 200 μg doxedetomidine, is used.
Category
Treatment - Drugs
2
Description
Second intervention group: includes 66 patients undergoing laparoscopic cholecystectomy and receiving paracetamol. These patients first receive 1 g of intravenous paracetamol before surgery and receive 500 mg paracetamol every 6 hours after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Taha Hojjati Ashrafi
Street address
Basig squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Fax
+98 86 3417 3619
Email
it-amiralmomenin@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Arjomandzadegan
Street address
Basij Square,
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
mmatinam81@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Taha Hojjati Ashrafi
Position
Surgery Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
4, Zeytoon Appartment, Behdari Street
City
Arak
Province
Markazi
Postal code
3819693357
Phone
+98 86 3313 1639
Email
taha.hojjati@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Taha Hojjati Ashrafi
Position
Surgery Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
4, Zeytoon Apartment, Behdari Street
City
Arak
Province
Markazi
Postal code
3819693357
Phone
+98 86 3313 1639
Email
taha.hojjati@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Taha Hojjati Ashrafi
Position
Surgery Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
4, Zeytoon Appartment, Behdari Street
City
Arak
Province
Markazi
Postal code
3819693357
Phone
+98 86 3313 1639
Email
taha.hojjati@arakmu.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available