Effect of vitamin B6 on rate of nausea and vomiting in patients after elective cesarean section
Design
Clinical trials with control group, parallel group, double blind, randomized
Settings and conduct
This study is done to evaluate the effect of vitamin B6 on pregnant women who are candidates for cesarean section who are referred to Besat Hospital in Sanandaj. The study is randomized and double blind.
Participants/Inclusion and exclusion criteria
Pregnant women candidate for elective cesarean section
Inclusion criteria:
1- Fasting for 8 hours before surgery
2- candidate for elective cesarean section
3. Patient's full health of the digestive tract
4- Filling out the consent form and willingness to participate in the study
5. Being monogamous
Exclusion criteria:
1. Contraindications for spinal anesthesia
2. History of vertigo and vomiting during pregnancy
3. Patients who have used anti-nausea and vomiting before surgery
4. Get psychotropic drugs
5. Patients with a BMI greater than 28
6- Patients with pre-eclampsia, eclampsia, hypertension, oesophageal hernia, gastroesophageal reflux disease
7. Patients with diabetes
Intervention groups
1. Group 1, 25 mg of vitamin B6 in combination with 500 ml of normal saline is given 20 minutes before surgery.
2- Group 2, 50 mg of vitamin B6 in combination with 500 ml of normal saline is injected 20 minutes before surgery.
3. Group 3, 100 mg of vitamin B6 in combination with 500 ml of normal saline is injected 20 minutes before surgery.
4. Group 4 (Control) 500 ml of normal saline is injected 20 minutes before surgery.
Main outcome variables
The incidence of nausea and vomiting, the amount of anti-emetic drugs Consumption, the patient's hospitalization time and the incidence of pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171216037910N1
Registration date:2019-04-19, 1398/01/30
Registration timing:prospective
Last update:2019-04-19, 1398/01/30
Update count:0
Registration date
2019-04-19, 1398/01/30
Registrant information
Name
Arvin Barzanji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3334 2561
Email address
arvin.barzanji1988@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Pyridoxine (Vitamin B6) effects on the Nausea and Vomiting Rates in Patients candidate for Elective Cesarean Section
Public title
Vitamin B6 in elective cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Fasting for 8 hours before surgery
candidate for elective cesarean section
Patient's full health of the digestive tract
Being monogamous
Filling out the consent form and willingness to participate in the study
Exclusion criteria:
Patients with diabetes
Contraindications for spinal anesthesia or Conversion of spinal anesthesia into general anesthesia during surgery
History of vertigo and vomiting during pregnancy
Patients who have used anti-emetic drugs before surgery
Get psychotropic or opioid drugs
Patients with a BMI greater than 28
Patients with pre-eclampsia, eclampsia, hypertension, oesophageal hernia, gastroesophageal reflux disease
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced (permuted) block randomization( four random blocks).
In each block, 4 patients are randomly assigned random codes A1, A2, A3 and B, and according to the corresponding code, they receive the dose and the desired drug or placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
The normal saline serum containing medicine or placebo is prepared and coded by a nurse who is not aware of the study process. The prescriber and collaborator, who completes the relevant assessments and completes the questionnaire, is not aware of the drug or placebo received by the patient. After completion of the data collection work, analyzes will be carried out based on the relevant codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Faculty of Medicine, Kurdistan University of Medical Sciences, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2018-06-26, 1397/04/05
Ethics committee reference number
IR.MUK.REC.1397.086
Health conditions studied
1
Description of health condition studied
Nausea and vomiting after surgery in cesarean section with spinal anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Primary outcome: nausea and vomiting
Timepoint
Nausea and vomiting are investigated during surgery and recovery time, and 2, 4, 6, 12, 18, and 24 hours after surgery.
Method of measurement
The BARF method is based on the BARF ruler and according to the smileys, scoring is done. 2. Qualitative method (Likert scoring criterion)
Secondary outcomes
1
Description
The amount of anti-emetic drugs
Timepoint
In the first 24 hours after surgery
Method of measurement
Dosage and frequency of administration
2
Description
Intensity of pain
Timepoint
Intensity of pain is investigated during recovery time, 2, 4, 6, 12, 18, and 24 hours after surgery.
Method of measurement
Pain is measured using the visual analog scale.
3
Description
The length of the recovery period
Timepoint
ّIn the recovery period
Method of measurement
Based on time (hours)
4
Description
The length of hospitalization
Timepoint
Patient admission period
Method of measurement
Based on time (day)
Intervention groups
1
Description
Intervention group:Prescribing vitamin B6 : 25 mg, 20 minutes before surgery (group 1)
Category
Treatment - Drugs
2
Description
Intervention group: Prescribing vitamin B6 : 50 mg, 20 minutes before surgery (group 2)
Category
Treatment - Drugs
3
Description
Intervention group: Prescribing vitamin B6 : 100 mg, 20 minutes before surgery (group 3)
Category
Treatment - Drugs
4
Description
Control group: In the control group, 500 ml of normal saline solution will be infused 20 minutes before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Seyed Arvin Barzanji
Street address
Merdoux Crossroads- Keshavarz Street -Azadi Square
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3328 5910
Email
besathospital@muk.ac.ir
Web page address
http://muk.ac.ir/Muk/Hospitals/Besat.aspx
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Ghaderi
Street address
Faculty of Medicine, Kurdistan University of Medical Sciences, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6614713446
Phone
+98 87 3366 4351
Email
f.rezaee@muk.ac.ir
Web page address
http://muk.ac.ir/Muk/ViceChancelleries/first.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Seyed Arvin Barzanji
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Paramedicine, Medical University of Kurdistan, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6614713446
Phone
+98 87 3334 2561
Fax
Email
arvin.barzanji1988@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Seyed Arvin Barzanji
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Paramedicine, Medical University of Kurdistan, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6614713446
Phone
+98 87 3334 2561
Fax
Email
arvin.barzanji1988@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Seyed Arvin Barzanji
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Paramedicine, Medical University of Kurdistan, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6614713446
Phone
+98 87 3334 2561
Fax
Email
arvin.barzanji1988@gmail.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