| CTRI Number |
CTRI/2023/08/056106 [Registered on: 03/08/2023] Trial Registered Prospectively |
| Last Modified On: |
28/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Vitamin C on surgical stress response in laparoscopic gynaecological surgery. |
|
Scientific Title of Study
|
Effect of preoperative intravenous Ascorbic acid on serum levels of C - Reactive Protein as a marker of surgical stress response in laparoscopic gynaecological procedure under general anaesthesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr L G Sreenath Pillai |
| Designation |
Postgraduate Resident |
| Affiliation |
Atal Bihari Vajpaee Institute Of Medical Sciences And Dr Ram Manohar Lohia Hospital |
| Address |
Room No 301,Department Of Anaesthesia
Atal Bihari Vajpayee Institute Of Medical Sciences And Dr Ram Manohar Lohia Hospital
Central DELHI 110001 India |
| Phone |
7065344676 |
| Fax |
|
| Email |
lgsreenathpillai@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Namita Arora |
| Designation |
Professor |
| Affiliation |
Atal Bihari Vajpaee Institute Of Medical Sciences And Dr Ram Manohar Lohia Hospital |
| Address |
Room no 301, Department of Anaesthesia, Atal Bihari Vajpaee Institute Of Medical Sciences And Dr Ram Manohar Lohia Hospital
Central DELHI 110001 India |
| Phone |
9868219619 |
| Fax |
|
| Email |
namitaarora16@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Namita Arora |
| Designation |
Professor |
| Affiliation |
Atal Bihari Vajpaee Institute Of Medical Sciences And Dr Ram Manohar Lohia Hospital |
| Address |
Room no 301, Department Of Anaesthesia
Atal Bihari Vajpaee Institute Of Medical Sciences And Dr Ram Manohar Lohia Hospital
Central DELHI 110001 India |
| Phone |
9868219619 |
| Fax |
|
| Email |
namitaarora16@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesia, Atal Bihari Vajpaee Institute Of Medical Sciences And Dr Ram Manohar Lohia Hospital |
|
|
Primary Sponsor
|
| Name |
Atal Bihari Vajpaee Institute Of Medical Sciences And Dr Ram Manohar Lohia Hospital |
| Address |
Room No 301,Department Of Anaesthesia
Atal Bihari Vajpayee Institute Of Medical Sciences And Dr Ram Manohar Lohia Hospital, 110001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr L G Sreenath Pillai |
Atal Bihari Vajpayee Institute Of Medical Sciences And Dr Ram Manohar Lohia Hospital |
Room No 301,Department Of Anaesthesia, Post Graduate Institute Building
Central DELHI |
7065344676
lgsreenathpillai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, Atal Bihari Vajpaee Institute Of Medical Sciences And Dr Ram Manohar Lohia Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Ascorbic Acid |
Intravenous Ascorbic Acid 1gm 20 minutes prior to intubation in 500ml Normal saline infusion |
| Comparator Agent |
Intravenous normal saline 1o ml |
Intravenous normal saline 1o ml in 500 ml Normal saline infusion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18 To 65 years posted for Elective Diagnostic Hysterolaparoscopic surgery.
ASA Class I AND II |
|
| ExclusionCriteria |
| Details |
Patients with endocrine morbidities such as Diabetes Mellitus, Hypopituitarism, Cushings disease
Patients with Hypertension.
Heart diseases such as Coronary Heart disease, Valvular Heart disease.
Patients already on Steroid treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum Level Of C- Reactive Protein |
T0 Baseline - Just After Cannulation
T1 - 5 Minutes After Creating Pneumoperitonium
T2 - Immediately After Extubation
T3 - 12 Hours After Extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Levels Of
A. Blood Sugar
B. Serum Cortisol |
T0 Baseline - Just After Cannulation
T1 - 5 Minutes After Creating Pneumoperitonium
T2 - Immediately After Extubation
T3 - 12 Hours After Extubation |
| Hemodynamic Stress Response.( Heart Rate, Systolic Blood Pressure , Diastolic Blood Pressure, Mean Arterial Pressure) |
T0 Baseline - Just After Cannulation
T1 - 5 Minutes After Creating Pneumoperitonium
T2 - Immediately After Extubation
T3 - 12 Hours After Extubation |
|
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [lgsreenathpillai@gmail.com].
- For how long will this data be available start date provided 01-07-2025 and end date provided 01-07-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Surgical stress is the systematic response to surgical injury and is characterized by activation of the sympathetic nervous system, endocrine responses as well as immunological and metabolic changes. In laparoscopic procedures intraperitoneal carbon dioxide insufflation and intraoperative organ handling also causes stress. As a result of these changes, plasma concentrations of neuroendocrine markers such as Cortisol, Glucagon, Insulin, Anti diuretic hormone and inflammatory immune markers such as C-Reactive Protein, Lactate, Catecholamines etc increases. When this response is uncontrolled, it leads to postoperative complications like tachycardia, increased myocardial oxygen demand, tissue hypoxia, cellular acidosis, and poor long term outcomes like muscle wasting, impaired immune function and delayed wound healing, and if left unattended, organ failure and death. Over the years many methods have been used to reduce the perioperative surgical stress response. These include using physiologic monitoring, providing balanced anaesthesia care and pain control, prescribing appropriate antibiotics, supporting patients by metabolic and nutritional means, and using new methods of imaging to aid in diagnosis. In pharmacological method of attenuating this surgical stress response variety of drugs have been studied, e.g.NSAIDS, Clonidine, Dexmedetomidine, opioids, Vitamin C etc. All of them show beneficial response to obtund the surgical stress response. Out of these Vitamin C has shown a proven role in reducing the inflammatory response in sepsis. It stimulates the immune system in response to inflammation, by enhancing T-lymphocyte proliferation, which is postulated to be done by inhibition of signalling pathways involved in T cell apoptosis. This action leads to increased cytokine production and immunoglobulin synthesis. Ascorbic acid being structurally similar to glucose, helps in prevention of non-enzymatic glycosylation of proteins .Ascorbic acid’s anti-inflammatory properties are due to its hepatic messenger RNA expression of the tumour factors and interleukins downregulation. Very few studies have studied the effect of intravenous vitamin C on acute stress response as the surgical stress response, showing benefits of pre-operative Vitamin C. But most of these studies are in western population. Hence, we have planned this study to evaluate the effect of preoperative intravenous ascorbic acid on surgical response in patients undergoing Diagnostic Hysterolaparoscopy surgery. |