Comparison Effects of Dexmedetomidine and Clonidine as Premedication in Perioperative Hemodynamic Stability and Post-op Pain in Laparoscopic Cholecystectomy
Comparison Effects of Dexmedetomidine and Clonidine as Premedication in Perioperative Hemodynamic Stability and Post-op Pain in Laparoscopic Cholecystectomy
Design
Double Blinded Randomized Clinical Trial
Settings and conduct
The study is performed in the operating room of Faghihi Hospital in Shiraz, after the anesthesiologist in charge of the study randomly divided patients into three groups. .
Clonidine and placebo tablets are given by the ward nurse who is unaware of the study groups. Dexmetomidine and normal saline (placebo) infusions are also provided by an anesthesiologist who is unaware of the study groups.
Drugs and placebo are then administered by the anesthesia personnel in the operating room.
After transferring the patient to the recovery room, no information will be given to the recovery staff.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Patients Candidate for Laparoscopic Cholecystectomy Surgery Age 18-65 years Class (ASA) I, II.
Exclusion Criteria:Communication problem Hypertension Heart disease Anemia Liver and Kidney Diseases Hormonal diseases Concurrent acute or chronic pain Gastrointestinal problems Sexual disorders CNS disorders Respiratory allergy Diabetes Pregnancy Duration of surgery more than 120 minutes.
Intervention groups
Intervention group 1:we start the dexmedetomidine infusion at a dose of 0.2 μg / kg ). Patients are given a tablet similar to clonidine 30 minutes before induction.
Intervention group 2:Oral administration of 0.2 mg clonidine 30 minutes prior to surgery and normal saline infusion begins with the same volume of dexmedomidine group (40 cc) as placebo.
Main outcome variables
Blood Pressure ,Nausea and Vomiting ,Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N96
Registration date:2020-01-20, 1398/10/30
Registration timing:prospective
Last update:2020-01-20, 1398/10/30
Update count:0
Registration date
2020-01-20, 1398/10/30
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-06-04, 1399/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Effects of Dexmedetomidine and Clonidine as Premedication in Perioperative Hemodynamic Stability and Post-op Pain in Laparoscopic Cholecystectomy
Public title
The effect of dexmedetomedine and clonidine on hemodynamics and postoperative pain of laparoscopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Candidate for Laparoscopic Cholecystectomy Surgery
Age 18-65 years
Class (ASA) I, II
Exclusion criteria:
Communication problem
Hypertension
Heart disease
Anemia
Liver and Kidney Diseases
Hormonal diseases
Concurrent acute or chronic pain
Gastrointestinal problems
Sexual disorders
CNS disorders
Respiratory allergy
Diabetes
Pregnancy
Duration of surgery more than 120 minutes
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were divided into 3 groups of 45 individuals using permutation block randomization method, obtained from WWW.Randomization.org.
Blinding (investigator's opinion)
Double blinded
Blinding description
The anesthesiologist in charge of carrying out the study based on a randomization chart divides the patients into three groups.
Clonidine and placebo tablets are given to patients by a ward nurse who is unaware of the study groups.
And the infusion of dexmedomidine and normal saline (placebo) is also provided by an anesthesiologist who is unaware of study groups and is provided by anesthesia staff in the operating room.
After the patient is transferred to the recovery room, no information will be given to the recovery staff. And the patient, the anesthesia resident, the recovery nurse, and the inpatient and nurse analyzer are all blind to the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2019-12-16, 1398/09/25
Ethics committee reference number
IR.SUMS.MED.REC.1398.520
Health conditions studied
1
Description of health condition studied
Laparoscopic Cholecystectomy
ICD-10 code
K80.44
ICD-10 code description
Calculus of bile duct with chronic cholecystitis without obstruction
Primary outcomes
1
Description
Blood Pressure
Timepoint
Before induction, after induction, at the onset of surgery and every 5 minutes until the end of the surgery.
Method of measurement
Monitoring
2
Description
Pain
Timepoint
At the onset of recovery and thereafter every 15 minutes until recovery discharge .
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Nausea and Vomiting
Timepoint
At the onset of recovery and thereafter every 15 minutes until recovery discharge .
Method of measurement
Nausea and vomiting grading scale
2
Description
Sedation
Timepoint
At the onset of recovery and thereafter every 15 minutes until recovery discharge
Method of measurement
Ramsay sedation scale
Intervention groups
1
Description
Intervention group: Dexmedetomidine infusion (Hospira, INC, Lake Forest, IL 60045 USA) is initiated 5 min before surgical incision at a dose of 0.2 μg / kg.One dose of clonidine similar to placebo (placebo made by Shiraz University of Medical Sciences Pharmacy) was given to patients 30 minutes before induction.
Category
Prevention
2
Description
Intervention group:Oral administration of 0.2 mg clonidine (Razavi Pharmaceutical Service Institute) 30 minutes prior to surgery and normal saline infusion begins with the same volume of dexmedomidine group (40 cc) as placebo (placebo made by Shiraz University of Medical Sciences Pharmacy) .
Category
Prevention
3
Description
Control group:The control group received only oral placebo (placebo made by Shiraz University of Medical Sciences Pharmacy) and normal saline in the same volume as the dexmedomidine group (40 cc).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Zahra Rafati
Street address
Shahid Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3233 1634
Email
faghihihsp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Rafati
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
rafati.z@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hosein Eghbal
Position
Anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
hosineghbal@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD