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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [lgsreenathpillai@gmail.com].

  6. 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.

  7. 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.

 
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