Comparison of the effect of Midazolam, Dexamethasone, Ondansetron and Propofol in the prevention of opioid-induced pruritus after spinal anesthesia in femoral fracture surgery
Comparison of the effect of Midazolam, Dexamethasone, Ondansetron and Propofol in the prevention of opioid-induced pruritus after spinal anesthesia in femoral fracture surgery
Design
Double-blind clinical trial, 132 patients, 4 parallel groups by simple randomization.The trial phase is 3.
Settings and conduct
Patients candidate for hip fracture surgery at Valiasr hospital in Arak are divided into 4 groups by simple randomization with envelopes.The study is double-blind. Outcome elevator and analyzer and participant are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 65 years, ASA class 1 and 2, femoral fracture surgery, no history of any skin condition associated with generalized itching, no complaints of pruritus before surgery, no history of drug addiction, no history of seasonal allergies, no history of long-term corticosteroid use, absence of motion sickness, absence of diabetes, absence of neuromuscular diseases
Exclusion criteria: Failure to anesthesia and use other methods, dissatisfaction.
Intervention groups
Intervention group 1: We inject 4 milligram Ondansetron bolus followed by 50 milliliter of distilled water with rate of 25 milliliter per hour.
Intervention group 2: We inject 2 milligram Propofol bolus initially and then 10 micro grams per kilogram per minute (intravenous infusion drug is poured into 50 milliliter syringes).
Intervention group 3: We inject 8 milligram Dexamethasone and then infuse 50 milliliter of distilled water with rate of 25 milliliter per hour.
Intervention group 4: We inject 0.03 milligram Midazolam bolus and then infuse 0.02 milligram in kilogram in hours.
Main outcome variables
Itching, sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N141
Registration date:2020-04-09, 1399/01/21
Registration timing:registered_while_recruiting
Last update:2020-04-09, 1399/01/21
Update count:0
Registration date
2020-04-09, 1399/01/21
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Midazolam, Dexamethasone, Ondansetron and Propofol in the prevention of opioid-induced pruritus after spinal anesthesia in femoral fracture surgery
Public title
Management of opioid-induced pruritus after spinal anesthesia in femoral fracture surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years
ASA class 1 and 2
Femoral fractures surgery
No history of any skin condition associated with generalized itching
No complaints of pruritus before surgery
No history of drug addiction
No history of seasonal allergies
No history of long-term corticosteroid use
Absence of motion sickness
Absence of diabetes
Absence of neuromuscular diseases
Exclusion criteria:
Failure in the anesthesia and use another method
Dissatisfaction
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in 4 groups A and B and C and D .
In this method, we write a few cards or letters as intervention groups and the same number of cards for the control group, then the cards are mixed. One card is taken out and its allocation is registered and the card is returned to the other cards after leaving. Then the cards are mixed again and then another card is picked up. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Outcome elevator and analyzer and participant are blind. Outcome elevator and analyzer and participant don't aware from grouping.
Each group of drugs will be prescribed as a bolus and then intravenous infusion. Patients and outcome elevator will be unaware of the prescribed medication. Bolus and infusion injection syringes as well as drug infusion sets will be covered with foil. After calculating the amount, the required drugs are drawn in 50 ML syringes and prescribed at the desired dose.
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
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-02-09, 1398/11/20
Ethics committee reference number
IR.ARAKMU.REC.1398.313
Health conditions studied
1
Description of health condition studied
Femoral fracture surgery
ICD-10 code
S72
ICD-10 code description
Fracture of femur
Primary outcomes
1
Description
Itching
Timepoint
During recovery and up to 12 hours after surgery, every 2 hours
Method of measurement
Observation
2
Description
Sedation
Timepoint
Every 15 minutes until the end of surgery and in recovery and then every 2 hours to 12 hours after surgery
Method of measurement
Ramsey score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: We inject 4 milligram Ondansetron bolus followed by 50 millileter of distilled water with rate of 25 millileter per hour.
Category
Treatment - Drugs
2
Description
Intervention group 2: We inject 2 milligram Propofol bolus initially and then 10 micro grams per kilogram per minute (intravenous infusion drug is poured into 50 milliliter syringes).
Category
Treatment - Drugs
3
Description
Intervention group 3: We inject 8 milligram Dexamethasone and then infuse 50 milliliter of distilled water with rate of 25 milliliter per hour.
Category
Treatment - Drugs
4
Description
Intervention group 4: We inject 0.03 milligram Midazolam bolus and then infuse 0.02 milligram per kilogram per hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?