The aim of the present study is to investigate the effect of Ketodex on postoperative pain intensity in opioid-dependent patients undergoing orthopedic ankle surgery
Design
This study will be done in the operating room. All of the drugs solution (Ketodex and placebo) of this study will be prepared by only one person who is aware of the study's grouping, in 50 ml syringes in the same shape. Anesthesiologist, patients, and all medical staff that will collaborate in the study will not aware of the drug allocated to each patient.
Settings and conduct
In the present double-blind clinical trial, which will be carried out in a parallel way, a total of 60 opioid-dependent patients who will be undergoing orthopedic ankle surgery under general anesthesia will be enrolled. Eligible patients will be randomly allocated into two equal A and B groups by block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all opioid-dependent patients who will be undergoing orthopedic ankle surgery under general anesthesia. Non-inclusion criteria: the history of cardiovascular disorders; seizure; brain tumor; taking illicit drugs; psychologic disorder and patient has ASA class III or more.
Intervention groups
Intervention group: for patients in group A, ketodex infusion will be started (Ketamine 0.1mg/Kg/min and dexmedetomidine 0.1 mic/Kg/min ) through a 50 ml syringe with the label A after induction of anesthesia till the end of surgery. Control group: patients in this group will receive IV infusion of physiologic saline with a 50 ml syringe with the label B during surgery.
Survey the effect of Ketodex on postoperative pain management of opioid-dependent patients undergoing orthopedic ankle surgery.
Public title
Survey the effect of mixture of two anesthetic drugs on control of postoperative pain of opioid dependent patients undergoing orthopedic ankle surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All opioid dependent patients who will be candidate for orthopedic ankle surgery under general anesthesia.
Exclusion criteria:
Patients with history of cardiovascular disorders
Patients with history of seizure disorder
Patients with history of brain tumor
Patients with history of taking illicit medications
Patients with history of psychologic disorder
If general anesthetic will not be used.
If patient has ASA class III or more.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated into two groups by block randomization. In this technique, a permutation block of size 4 will be made for patients of two groups A & B. In each block, equal numbers for two groups will be considered in alternative positions. Then 15 blocks of size 4 will be selected randomly and
patients will be allocated randomly and equally into three groups according to these permutation block.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blindness, All of the drugs solution (ketodex and normal saline) of this study will be prepared in 50 ml syringes that are similar and equal in shape, by a nurse of anesthesia who is aware of patients' grouping. These syringes will have labels A or B. An anesthesiologist who will use these syringes will not aware of the content of these syringes, and just will use syringes with label A for patients in group A and syringes with label B for patients in group B. Patients and all medical staffs who will collaborate in data gathering, will not be aware of the content of these syringes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
197871345
Approval date
2020-10-13, 1399/07/22
Ethics committee reference number
IR.SUMS.MED.REC.1399.424
Health conditions studied
1
Description of health condition studied
Acute pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Postoperative analgesia
Timepoint
Every 15 min after patients will become awake in post-anesthesia care unit (PACU). During the first 24 h, postoperative analgesia will be evaluated every 2 hr for 8 hr then every 4 hr till 24 hr.
Method of measurement
By using Numerical Rating Pain Score (0= No pain,...10= the most severe pain that could imagine)
Secondary outcomes
1
Description
Sedation
Timepoint
Every 15 minute in PACU (post anesthesia care unit )
Method of measurement
By using Ramsay sedation score: 0 = Restless , 1 = Calm, 2 = Sleepy, 3 = Drowsy with response to verbal stimuli , 4 = Drowsy without response to verbal stimuli, 5 = Without response to painfull stimuli
2
Description
Postoperative nausea and vomiting
Timepoint
Every 4 hr. during first 24 hr. post operation.
Method of measurement
By using 3-point scale: 0 = no nausea, vomiting, 1 = nausea only, and 2 = retching or/and vomiting
3
Description
Mean arterial blood pressure (MAP)
Timepoint
Values will record every 15 minutes till end of surgery.
Method of measurement
Non invasive blood pressure monitoring.
4
Description
Heart rate per minute
Timepoint
Values will record every 15 minutes till end of surgery.
Method of measurement
Electrocardiogram
Intervention groups
1
Description
Intervention group: patients in group A, Ketodex infusion (Ketamine 0.1mg/Kg/min and Dexmedetomidine 0.1 mic/Kg/min ) will be started through a 50 ml syringe with the label A after induction of anesthesia till the end of surgery.
Category
Treatment - Drugs
2
Description
Control group: after induction of anesthesia, patients in group B will received intravenous infusion of the normal saline through a 50 ml syringe with the label B till end of surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Training and Medical Center operation room
Full name of responsible person
Mohammad Ali Sahmeddini
Street address
Operating room, Chamran Training and Medical Center, Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3624 0101
Fax
+98 71 3623 4507
Email
chamhosp@sums.ac.ir
Web page address
https://chamran.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abas Rezaieanzade
Street address
Shiraz University Of Medical Sciences building, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir
Grant name
Grant code / Reference number
98-01-01-21541
Is the source of funding the same sponsor organization/entity?