Effect of combined Paracetamol(Apotel) and Dexamethasone versus Paracetamol(Apotel) on post operative nausea vomiting after cesarean section
Design
Clinical trial with 2 parallel groups, double blind, randomised, phase 3 on 100 patients, in block randomization method with the size of 4 and 6, Random sequence will be generated by running an online program in sealed envelope website (https://www.sealedenvelope.com/).
Settings and conduct
This is a double blind clinical trial study with 100 patients referred to Taleghani hospital.They will be devided into 2 groups (Apotel and combined Apotel-Dexamethasone)randomly.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 18-45 years
Having informed consent
Having ASA I and II ( American Society of Anesthesiologists)
Nulliparous
Singleton pregnancy
Patients with elective cesarean
Patients with spinal anesthesia
Patients with Pfannenstiel incision in surgery.
Non-inclusion criteria:
Underlying disease (i.e renal, liver, cardiac and pulmonary disease)
History of allergy to the drugs of study
Addiction or long term using of opiate
Coagulopathy or use of anticoagulant drugs
Disability for pain scoring
Suffering from preeclampsia or HELLP (hemolysis,elevated liver enzymes,low platelet count) or eclampsia or hepatitis
Urgency cesarean section
Intervention groups
In first group 2 cc of distilled water and in second group 8 mg of Dexamethasone 30 minutes before spinal anesthesia and in both goups 1 gr of Apotel immediately after spinal anesthesia will be intravenously injected to the patients.
Main outcome variables
Vomitting score and happening of nauseae after cesarean section till 24 hours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201028049175N6
Registration date:2021-03-02, 1399/12/12
Registration timing:registered_while_recruiting
Last update:2021-03-02, 1399/12/12
Update count:0
Registration date
2021-03-02, 1399/12/12
Registrant information
Name
Shamim Valibak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
sh.valibak@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of combined Paracetamol(Apotel) and Dexamethasone versus Paracetamol(Apotel) on post operative nausea vomiting after cesarean section
Public title
Evaluation of anti analgesic and anti inflammatory drugs effect on decreasing of post operative nausea vomiting after cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-45 years
Having informed consent
Having ASA I and II
Nulliparous
Singleton pregnancy
Patients with elective cesarean
Patients with spinal anesthesia
Patients with Pfannenstiel incision in surgery.
Exclusion criteria:
Underlying disease (i.e renal, liver, cardiac and pulmonary disease)
History of allergy to the drugs of study
Addiction or long term using of opiate
Coagulopathy or use of anticoagulant drugs
Disability for pain scoring
Suffering from preeclampsia or HELLP or eclampsia or hepatitis
Urgency cesarean section
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
To create simple random sequences web randomization
(com.graphpad.www) dual group and for concealment, closed envelope method with random sequence (SNOSE) will be used.Random sequences will be recorded on the cards and then sequentally puted in the envelopes.In order to preserve random sequences the outer surface of the envelopes are numbered, respectively. Finally, the lid of the letter envelopes was pasted and it is placed inside the boxes, respectively.At the time of participants registration, one of the envelopes will be opened and the allocation group, will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients blindness:
According to injecting of Dexamethasone in one group of study 30 minutes before spinal anesthesia, in another group distilled water will be injected to the patients in same time and measure.
Researcher blindness:
Drugs will be ordered by specialist, so the researcher who filled the check lists is blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Basij square
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2021-01-03, 1399/10/14
Ethics committee reference number
IR.ARAKMU.REC.1399.290
Health conditions studied
1
Description of health condition studied
Nausea and vomitting after cesarean
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nausea happening after cesarean section untill 24 hours after surgery
Timepoint
In recovery room and 2,4,6,12,24 hours after surgery
Method of measurement
Asking of patient
2
Description
Vomitting score after cesarean section untill 24 hours after surgery
Timepoint
In recovery room and 2,4,6,12,24 hours after surgery
Method of measurement
VAS (Visual Analog Scale) score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:8 mg of Dexamethasone (Daroo pakhsh company) intravenously will be injected to the patients, 30 minutes before spinal anesthesia and 1 gr of Apotel (Exir company) intravenously will be injected immediately after spinal anesthesia.
Category
Treatment - Drugs
2
Description
Control group:2 cc of distilled water intravenously will be injected to the patients, 30 minutes before spinal anesthesia and 1 gr of Apotel (Exir company)intravenously will be injected immediately after spinal anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Maryam Maktabi
Street address
West side of Emam Khomeini street, beside of gas company
City
Arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3277 6063
Email
It-taleghani@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Basij square
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Maryam Maktabi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
West side of Emam Khomeini street, beside of gas company
City
Arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3277 6063
Email
Dr.maryam.maktabi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
086-32222003-8
Email
alikamaliir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Shamim Valibak
Position
General physician non-faculty
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
086-32222003-8
Email
sh.valibak@yahoo.com
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