Evaluation of the relationship between ketamine infusion on pain control and hemodynamics in opiate addicts undergoing cardiac surgery
Design
Since the present study is a clinical trial of efficacy determination, the following formula was used to calculate sample size.
Α = 0.05 and β = 0.20 were used to calculate the sample size and the difference was considered to be 2%.
n = 2 * [1.645 + 0.845 / 0.4 - 0.1] 2 * 0.4 (0.6) = 33
In order to increase the accuracy of the study, at the end of each group, 5 patients will be examined
Settings and conduct
Operating room and icu
Participants/Inclusion and exclusion criteria
1-Fill out the consent form and desire to participate in the study
2- At least one year history of opiate use
3. Age less than 75 years
4- No history of mental illness
Intervention groups
A single dose of continuous-dose ketamine (30mcg / kg / min) after induction of anesthesia until the end of surgery and continued with a dose (5mcg / kg / min) up to 6 hours after surgery.
Main outcome variables
Pain and hemodynamic changes during and after anesthesia in addicts are difficult to control and usually require high doses of opioids. Patients are resistant to opioids used in anesthesia and ketamine affects various opioid and non-opioid receptors and produces analgesic effects. In opiate-dependent patients, the effect of non-opioid receptors on the sensitivity of these patients to This drug causes analgesia and consequently results in less use of epi The vids will ache better during and after surgery and control.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190731044389N1
Registration date:2019-08-20, 1398/05/29
Registration timing:prospective
Last update:2019-08-20, 1398/05/29
Update count:0
Registration date
2019-08-20, 1398/05/29
Registrant information
Name
Payman Rezagholi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3318 0980
Email address
paimanrezagholy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ketamine infusion on the control of pain and hemodynamics of addicted patients in cardiac surgery
Public title
The effect of ketamine infusion on the control of pain and hemodynamics
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Fill out the consent form and desire to participate in the study
At least one year history of opiate use
Age less than 75 years
No history of mental illness
Exclusion criteria:
1. People whose pumping time exceeds 100 minutes
Extending the extubation timReturn to the operating room for some reason after the operatione
Unusual bleeding during surgery and after surgery
Extreme and prolonged hypotension
Surgery without cardiopulmonary pump
Return to the operating room for some reason after the operation
Patient's personal desire to quit research and not continue to cooperate without giving an explanation
Kidney failure
Liver failure
Age
From 18 years old to 75 years old
Gender
Both
Phase
1-2
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Using simple random method and random number table, patients will be selected by available method and divided into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is a double-blind clinical trial and will be drawn and infused by a nurse with the same syringe as ketamine and normal salinebike, and the researcher will have no information about the contents of the syringes until the end of the study. Also, the nurse will not be aware of the study process and will only assist in the preparation of the medication
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences