Comparing the effect of vitamin C and vitamin E administration on pain and TNF-α serum level in patients undergoing major surgery with general anesthesia
The aim of this study is to compare the effect of using vitamin C and vitamin E on prevention of pain and increased serum TNF-α levels in major surgery.
Design
Community-based, applied, randomized, triple-blind controlled clinical trial with parallel groups design
Settings and conduct
The study population consisted of 150 patients referring to Shahrekord Ayatollah Kashani hospital, who were candidate for major surgery lasting longer than an hour (Including: open prostatectomy, hysterectomy, cystichema and cholecystectomy) and were selected by convenience sampling.
Participants/Inclusion and exclusion criteria
Inclusion criteria were being candidate for major surgery lasting longer than an hour (including: open prostatectomy, hysterectomy, cystichema and cholecystectomy) and the ASA physical status classes 1 and 2. In addition, prohibition of general anesthesia in patients; history of taking any supplements or antioxidants before surgery such as vitamin C and vitamin E; and a history of taking any medication that interferes with the oxidant or antioxidant agents prevented from being enrolled in the study.
Intervention groups
Patients were divided into three groups of 50 each by convenience random allocation, and each group separartely received 2 grams of vitamin C, 400 units of vitamin E and placebo tablets, 48 hours before anesthesia induction. Blood samples are taken to determine the serum TNF-α level 12 hours before induction and 6 hours after the completion of surgery. The pain level was measured by the Visual Analog Scale (VAS).
Main outcome variables
Severity of pain; serum TNF-α levels; Level of coagulation factors (BT, PT, PTT, INR levels)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110514006480N15
Registration date:2018-07-08, 1397/04/17
Registration timing:registered_while_recruiting
Last update:2018-07-08, 1397/04/17
Update count:0
Registration date
2018-07-08, 1397/04/17
Registrant information
Name
Mohammad Taghi Moradi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
mtmoradi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of vitamin C and vitamin E administration on pain and TNF-α serum level in patients undergoing major surgery with general anesthesia
Public title
Effect of Vit C and Vit E on pain and TNF-α serum level in major surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients candidate for major surgery, longer than an hour (Including: open prostatectomy, hysterectomy, cystichema and cholecystectomy)
The ASA physical status classification system in one or two classes
Exclusion criteria:
Prohibition of general anesthesia in patients
History of taking any supplements or antioxidants before surgery such as vitamin C and vitamin E
A history of taking any medication that interferes with the oxidant or antioxidant agents
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into three groups by simple random sampling and Using three categories of cards that listed on them the letters A, B and C
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, considering that medications are given to patients as pills; the patient is not aware of the type of medicine And only clinical nurse knows the groups and identifies them with groups A, B and C. Researcher and data analyzer also checks the groups with the names A, B, and C.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ُShahrekord University of Medical Sciences
Street address
Ayatollah Kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2017-04-30, 1396/02/10
Ethics committee reference number
IR.SKUMS.REC.1395.325
Health conditions studied
1
Description of health condition studied
major surgery
ICD-10 code
Z92.4
ICD-10 code description
Personal history of major surgery
Primary outcomes
1
Description
Severity of pain
Timepoint
Before the intervention, 6 hours after the completion of the surgery
Method of measurement
Visual analog scale
2
Description
serum TNF-α levels
Timepoint
Before the intervention, 6 hours after the completion of the surgery
Method of measurement
ELISA Kit
Secondary outcomes
1
Description
Prothrombin Time
Timepoint
Before the intervention, 6 hours after the completion of the surgery
Method of measurement
Prothrombin Time Test
2
Description
Partial Thromboplastin Time
Timepoint
Before the intervention, 6 hours after the completion of the surgery
Method of measurement
Partial Thromboplastin Time Test
3
Description
International Normalized Ratio
Timepoint
Before the intervention, 6 hours after the completion of the surgery
Method of measurement
International Normalized Ratio Test
4
Description
Bleeding Time
Timepoint
Before the intervention, 6 hours after the completion of the surgery
Method of measurement
Bleeding Time Test
Intervention groups
1
Description
Intervention group 1: Forty eight hours before anesthesia, 2 grams of vitamin C is prescribed.
Category
Treatment - Drugs
2
Description
Intervention group: Forty eight hours before anesthesia, 400 IU of vitamin E is prescribed.
Category
Treatment - Drugs
3
Description
Control group: Forty eight hours before anesthesia, Placebo pill (containing starch compound) is prescribed.