Investigating the effects of intravenous Vitamin C on stress response severity in prolonged preoperative fasting time in abdominal hysterectomy surgery
Determine the effect of vitamin C on the severity of stress responses following long-term fasting
Design
A double-blinded and randomized clinical trial with parallel groups design of 60 patients
Settings and conduct
This study will be performed as a double-blinded clinical trial at Al-Zahra Educational Center. In the treatment group, when the patient's fasting time is more than twelve hours,1 gram of vitamin C will be injected into 500 milliliters of normal saline and will be infused in 20 minutes. In the control group, the same amount of normal saline will be injected in the serum. Anesthesiologist, the assessor, and the patients are unaware of type of treatment group. For all patients, general anesthetic method will be used with the same technique. All patients will be operated by one surgeon. In the last 15 minutes of surgery, 1 gram of paracetamol and 4 milligrams of Ondansetron will be infused for all patients. To measure the plasma level of CRP and glucose, the blood sample will be taken prior to infusion of vitamin C and 24 and 48 hours later. The length of stay in the hospital will also be recorded. Systolic and diastolic blood pressure and heart rate will be measured at the same times. Finally, results will be compared in two groups.
Participants/Inclusion and exclusion criteria
Entry Criteria: candidates of elective hysterectomy, between 35-65 years with a fasting time more than 12 hours.
Non-entry criteria: patient dissatisfaction, hysterectomy in malignancy, accompanying surgery, patients under steroid therapy, endometriosis, diabetes
Intervention groups
group of vitamins C (500 milligrams in 5 milliliters), control group (5 milliliters normal saline) infused into 500 milliliters normal saline serum within 20 minutes.
Main outcome variables
Changes in plasma levels of CRP and blood glucose after vitamin C injection in patients with fasting time more than 12 hours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130814014359N5
Registration date:2019-01-22, 1397/11/02
Registration timing:prospective
Last update:2019-01-22, 1397/11/02
Update count:0
Registration date
2019-01-22, 1397/11/02
Registrant information
Name
Vally Imantalab
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 9064
Email address
vimantalab@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of intravenous Vitamin C on stress response severity in prolonged preoperative fasting time in abdominal hysterectomy surgery
Public title
The effect of vitamin C on stress intensity in long-term fasting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients, candidate for elective abdominal hysterectomy
Age between 35-65
Fasting time, more than 12 hours
Exclusion criteria:
Patient dissatisfaction
Hysterectomy in malignancy
Accompanying surgery
Patients under treatment with steroids, including inflammatory and rheumatic diseases
endometriosis
Diabetes type one and two
Pelvic inflammatory diseases
transfusion during surgery
Age
From 35 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized with quadruple blocks and divide into two groups of treatment and control. The randomization unit is individual. In this randomization, we do not have a layer and we use a random numbers table tool. After providing the list, we will give it to the anesthetic technician who is not a member of the research team, to categorize patients in control or treatment groups based on the list.
Blinding (investigator's opinion)
Double blinded
Blinding description
Vitamin C and placebo (normal saline) are prepared by an anesthetic technician who is not a member of this research group and will be coded in similar 5-millimeter syringes and will be given to the responsible anesthesiologist. By her, the drugs are injected into 500 ml of normal saline and will be infused within 20 minutes. In this study patients, the responsible anesthesiologist and the assessor are blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Guilan University Of Medical Sciences
Street address
Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2018-12-29, 1397/10/08
Ethics committee reference number
IR.GUMS.REC.1397.379
Health conditions studied
1
Description of health condition studied
Stress responses in prolonged preoperative fasting In abdominal hysterectomy surgery
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders
Primary outcomes
1
Description
Changes in CRP factor levels in blood
Timepoint
Prior to infusion of vitamin C, 24 and 48 hours after surgery
Method of measurement
Taking blood sample
2
Description
Changes glucose levels in blood
Timepoint
Prior to infusion of vitamin C, 24 and 48 hours after surgery
Method of measurement
Taking blood sample
Secondary outcomes
1
Description
Systolic and diastolic blood pressure changes
Timepoint
Prior to infusion of vitamin C, 24, 48 hours after surgery
Method of measurement
Measuring the patient's blood pressure
2
Description
Changes in heart rate
Timepoint
Prior to infusion of vitamin C, 24, 48 hours after surgery
Method of measurement
Getting the patient's pulse
3
Description
Duration of staying in the hospital
Timepoint
discharge day
Method of measurement
Number of days in hospital
Intervention groups
1
Description
Intervention group: The vitamin C group: when the patient's fasting time is about twelve hours, one gram vitamin C (500 milligrams in 5 milliliters, manufactured by Osveh Pharmaceutical Company) will be injected into 500-milliliter normal saline serum and infused within 20 minutes.
Category
Prevention
2
Description
Control group: placebo group: 5 milliliters of normal saline will be injected into 500-milliliter normal saline serum and infused within 20 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr Gelareh Biazar
Street address
Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9324
Fax
+98 13 3336 9024
Email
azzahra@gums.ac.ir
Web page address
http://www.gums.ac.ir/azzahra
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Street address
Shahid Siadati Avenue, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?