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Comparison between effects of intravenous infusion Ibuprofen vs Morphine – Paracetamol on Platelet function in patients under supratentorial brain lesions resection

Protocol summary

Study aim
The main purpose was to determine the effect on platelet function of intravenous injection of ibuprofen with morphine-paracetamol using PFa-100.
Design
A clinical trial with two groups of intravenous infusion Ibuprofen and Morphine – Paracetamol, with parallel groups, randomized based on simple randomization with https://www.randomizer.org site, single blind Phase 3 on 15 patients in each group (totally 30)
Settings and conduct
In this randomized clinical trial single blind study, patients who are candidates for elective craniotomy surgery in Imam Hossein Hospital (1400-1401)are divided into two groups of 15 people - group I (B) and II (M-P). In both groups, at the beginning of Dora ligation, a blood sample was sent to assess coagulation disorder using the PFA-100 test, and then in a group I (B) ibuprofen 400 mg over 30 and in group II (MP) morphine 0.05 mg. G / kg is injected in the form of blues + paracetamol 1000 mg in half an hour. One hour after the injection, blood samples from both groups are sent for PFA-100 testing.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 30 (two groups of 15) patients who are candidates for elective craniotomy surgery more than 16 years, no history of illegal inventions, gastrointestinal, liver, heart, kidney, diabetes, etc. Exclusion criteria: Hematocrit less than 25% During surgery, reduce your body to less than 36%
Intervention groups
Intervention 1- In group I, after removal of the brain lesion (at the beginning of Dora closure), 400 mg of ibuprofen solution is infused intravenously within 30 minutes. Intervention 2 - In group II, after removal of the brain lesion (at the beginning of Dora closure), morphine 0.05 mg/kg intravenous blues with 1000 mg of paracetamol is infused for 30 minutes.
Main outcome variables
Blood Platelet function - pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210506051200N1
Registration date: 2021-06-06, 1400/03/16
Registration timing: prospective

Last update: 2021-06-06, 1400/03/16
Update count: 0
Registration date
2021-06-06, 1400/03/16
Registrant information
Name
Sohrab Salimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2221 2058
Email address
ssalimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between effects of intravenous infusion Ibuprofen vs Morphine – Paracetamol on Platelet function in patients under supratentorial brain lesions resection
Public title
Comparison between effects of intravenous infusion Ibuprofen vs Morphine – Paracetamol on blood Platelet function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All surgeries for supratentorial lesions No history of coagulation disorders No history of gastrointestinal disease No history of liver disease Discontinue drugs that cause coagulation disorders No history of heart disease No history of renal failure (creatinine clearance <70 mL / min, oliguria or dialysis within 28 days before surgery) No history of diabetes No history of asthma Absence of 2 or more of the following:Alanine aminotransferase> 165 U / L, aspartate transaminase>, 120 U / L Alkaline phosphatase> 345 U / L (three cases too normal) Inability to obtain the consent of the patient or companions No history of disorders due to hypersensitivity to ibuprofen, aspirin, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors - Women in non-pregnancy status No long-term use of anticonvulsant drugs No dependence or tolerance on drugs Weight higher than 30 kg No gastrointestinal bleeding during the last 6 weeks Do not take warfarin, lithium or concomitant use of lasix and angiotensin converting enzyme inhibitors
Exclusion criteria:
Hematocrit less than 25% during surgery Reduction of body temperature to less than 36 ° C
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
-Randomization method: Simple randomization -Randomization unit: individual -Randomization tool: Randomization will be done using the site https://www.randomizer.org which using random numbers extracted by the software, patients will be given one of the two groups of intravenous infusion Ibuprofen and Morphine – Paracetamol .
Blinding (investigator's opinion)
Single blinded
Blinding description
Drugs for both groups will be prepared and coded by one of the researchers in the study. Who will be aware of the type of drug will be injected. Because the participants are unconscious during the injection, they are spontaneously blind, and therefore only the patient does not know the type of drug used.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethical commite of Shahid Beheshti Medical University
Street address
Shahid Beheshti University of Medical Sciences, Shahid Erabi St, Ebne Yaman St, Shahid Chamran Highway, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-07-02, 1398/04/11
Ethics committee reference number
IR.SBMU.MSP.REC.1398.307

Health conditions studied

1

Description of health condition studied
supratentorial brain lesions
ICD-10 code
D33.0
ICD-10 code description
Benign neoplasm of brain, supratentorial

Primary outcomes

1

Description
Platelet function using PFa-100(CBC, PT, PTT, Ca2+, PFa-100, INR, Fibrinogen, serum osmolality, ABG)
Timepoint
Once the Dora closure begins, a blood sample is taken first to measure coagulation abnormality using the PFa-100 test. Also, one hour after the injection is completed, blood samples are taken from both groups for the PFa-100 test.
Method of measurement
The PFA-100 system is a platelet function analyzer designed to measure primary platelet-dependent homeostasis.(Platelet Function Assay or Platelet Function Analyzer): PFA-100

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: infusion Ibuprofen.In group I, 400 mg of ibuprofen solution is infused intravenously over 30 minutes after removal of the brain lesion (at the beginning of Dora closure).
Category
Treatment - Drugs

2

Description
Intervention group: Morphine – Paracetamol.In group II, after removal of the brain lesion (at the beginning of Dora closure), morphine is infused 0.05 mg / kg intravenously with 1000 mg paracetamol for 30 minutes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان امام حسین
Full name of responsible person
سهراب سلیمی
Street address
تهران، خیابان شهید مدنی، بیمارستان امام حسین
City
تهران
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
ssalimi@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
afshin zarghi
Street address
University Blvd, Velenjak
City
tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 2243 9781
Email
mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
sohrab salimi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossein Hospital, Shahid Madani St
City
tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
ssalimi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
sohrab salimi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossein Hospital, Shahid Madani St
City
تهران
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
m.yaseri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
sohrab salimi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
خ شهید مدنی، بیمارستان امام حسین
City
tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
ssalimi@sbmu.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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