1. Determining the frequency distribution of the studied population based on demographic characteristics
2. Determining and comparing the average glycosylated hemoglobin before and after hip and femur surgery in two groups
3. Determining and comparing the frequency and type of drug use before and after hip and femur surgery in two groups
4. Determining and comparing the type of surgery of patients in hip and femur surgeries in two groups
5. Determining and comparing the average scores of pain, nausea and vomiting, equivalent consumption of morphine, use of antiemetics, use of Andasterone at 4-hour intervals after hip and femur surgeries in two groups
6. Determining and comparing the average length of stay in the hospital after hip and femur surgery in two experimental and control groups.
Design
Clinical trial with a control group, three blinded, randomized, on 140 patients who were used for randomization from groups A and B.
Settings and conduct
The study population is people admitted for hip and femur surgery in Imam Khomeini Hospital in 2022. Before the operation, patients in both groups will receive a single oral dose of acetaminophen 1000 mg and pregabalin 100 mg. In the intervention group, patients will receive 10 mg of dexamethasone intravenously in 90 minutes after surgery.
Participants/Inclusion and exclusion criteria
Patients over 18 years old in 2022 who undergo hip and femur surgery were defined. Exclusion criteria include: patients undergoing surgery, or having a history of recent pregnancy, using steroid or immunosuppressive drugs within 6 months after kidney or liver surgery, and having drug and alcohol abuse.
Intervention groups
Intervention Patients will receive 10 mg of dexamethasone intravenously in 90 minutes after surgery.
Main outcome variables
Reducing narcotics and reducing pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181112041616N2
Registration date:2023-08-28, 1402/06/06
Registration timing:prospective
Last update:2023-08-28, 1402/06/06
Update count:0
Registration date
2023-08-28, 1402/06/06
Registrant information
Name
Ehsan Movahed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3213 3151
Email address
e.movahed@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dexamethasone on antiemetic use after pelvic and femoral surgery in patients
Public title
The effect of dexamethasone on antiemetics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients over 18 years old in 2022 who undergo hip and femur surgery
Exclusion criteria:
Patients who are undergoing surgery or have a recent history of pregnancy, use steroid or immunosuppressant drugs within 6 months after kidney or liver surgery, and have drug and alcohol abuse.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
A code of 1 to 140 is considered for each questionnaire. And the random assignment is that we consider two groups named A and B, after that we put even numbers in group A and odd numbers in group B, and finally one group is called intervention and the other group. We consider it as control.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, principal investigator, physicians, nurses, orthopedic surgeons, data collection and outcome assessors, and the data safety and monitoring committee.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی جیرفت
Street address
Shahid Square - Jiroft University of Medical Sciences
City
Jiroft
Province
Kerman
Postal code
7861634200
Approval date
2023-08-27, 1402/06/05
Ethics committee reference number
IR.Jmu.Rec. 1402.025
Health conditions studied
1
Description of health condition studied
Hip and femur surgery
ICD-10 code
M95-M99
ICD-10 code description
Other acquired deformities of musculoskeletal system and connective tissue
Primary outcomes
1
Description
Pain score scale, use of antiemetic drug after surgery
Timepoint
Oxycodone 5 mg orally every 12 hours for moderate pain and 4 mg of ondansetron postoperatively every 4-6 hours to control nausea and vomiting.
Method of measurement
Oxycodone 5 mg orally every 12 hours for moderate pain and 4 mg of ondansetron postoperatively every 4-6 hours to control nausea and vomiting.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before the operation, patients in both groups will receive a single oral dose of acetaminophen 1000 mg and pregabalin 100 mg. In the intervention group, patients will receive 10 mg of dexamethasone intravenously in 90 minutes after surgery. A local infiltration cocktail of 62 ml was injected during the operation, which consists of the following drugs: Also, in both groups, all patients during the first 24 hours after the operation, (3 mg/kg and the maximum dose of 300 mg, 60 ml) 0.5% ropivacaine , will receive 30 mg (1 ml) of ketorolac and 5 mac/kg of epinephrine. Analgesics: acetaminophen 1000 mg orally every 8 hours, oxycodone 5 mg orally every 12 hours as needed for moderate pain or 10 mg for severe pain, meloxicam 7.5 mg orally every 12 hours, gabapentin 100 mg orally every 12 hours 12 hours and diazepam 5 mg orally as needed for muscle spasms. In addition, patients in both groups will receive more opioid analgesics as needed. If necessary, intravenous doses of four milligrams of ondansetron will be prescribed every 4-6 hours to control post-operative nausea and vomiting (PONV). Prochloroprazine will be used as a secondary antiemetic. Complications such as readmission, infection, reoperation, dislocation, venous thrombosis, pulmonary embolism, pneumonia and other post-operative cases are also investigated.To collect medical records information: age, sex, body mass index, type of surgery, smoking status, diabetes status and measurement of glycosylated hemoglobin less than 3 months before surgery will be used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان امام خمینی
Full name of responsible person
دکتر سینا حیدری
Street address
Shahid Square - Imam Khomeini Hospital
City
Jiroft
Province
Kerman
Postal code
7861634200
Phone
+98 34 4331 8085
Email
ehsanmovahed89@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
یاسین سهرنی
Street address
Shahid Square - Imam Khomeini Hospital
City
Jiroft
Province
Kerman
Postal code
7861634200
Phone
+98 34 4331 7302
Email
ehsanmovahed89@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jeeroft 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
Jeeroft University of Medical Sciences
Full name of responsible person
دکتر سینا حیدری
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Square - Imam Khomeini Hospital
City
Jiroft
Province
Kerman
Postal code
7861634200
Phone
+98 34 4331 7302
Email
ehsanmovahed89@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Yasin Sohrani
Position
Master's Degree in Epidemiology - Hospital Research Officer
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Square - Imam Khomeini Hospital
City
Jiroft
Province
Kerman
Postal code
7861634200
Phone
+98 34 4331 7302
Email
ehsanmovahed89@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ehsan Movahed
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
No. 1, west Red Crescent َََAve., Republic Blvd, Kerman Town
City
Kerman
Province
Kerman
Postal code
7861634200
Phone
+98 34 3213 3151
Fax
Email
e.movahed@ssu.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