| CTRI Number |
CTRI/2024/05/068216 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of various advantages of drinking sugar rich water versus drinking coconut water before operations in patients who are going to have operations of the abdomen. |
|
Scientific Title of Study
|
Comparison of two types of carbohydrate loading- carbohydrate rich fluid versus commercially prepared coconut water in terms of peri-operative morbidities in patients undergoing elective, abdominal surgeries
- A Randomized Control Trial.
|
| 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 Borna Das |
| Designation |
PG Registrar MD Anaesthesiology |
| Affiliation |
Christian Medical College Vellore |
| Address |
Anaesthesia Office
Department of Anaesthesia
Paul Brand Building
Main Campus
Christian Medical College Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9597737848 |
| Fax |
|
| Email |
bornadas2011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ekta Rai |
| Designation |
Professor, Anesthesiology |
| Affiliation |
Christian Medical College Vellore |
| Address |
Anaesthesia Office
Department of Anaesthesia
Paul Brand Building
Main Campus
Christian Medical College Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9789250113 |
| Fax |
|
| Email |
drektarai@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Borna Das |
| Designation |
PG Registrar MD Anaesthesiology |
| Affiliation |
Christian Medical College Vellore |
| Address |
Anaesthesia Office
Department of Anaesthesia
Paul Brand Building
Main Campus
Christian Medical College Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9597737848 |
| Fax |
|
| Email |
bornadas2011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Internal Fluid Research Grant Christian Medical College Vellore |
|
|
Primary Sponsor
|
| Name |
Internal Fluid Research Grant |
| Address |
Research Office
1st Floor, Carman Block
Bagayam Campus
Christian Medical College Vellore
Tamil Nadu 632002 |
| Type of Sponsor |
Private 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 Borna Das |
Christian Medical College Vellore Hospital |
General Surgery Division- Units II, III, IV (wards P2, P3, A5, O6E, O3W)
Hepato-pancreato-biliary surgery (ward - RHPB)
Vellore
TAMIL NADU |
9597737848
bornadas2011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical College Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
commercially prepared coconut water |
30 gm of commercially prepared (prepared using flash freeze technique, preservative free) coconut powder containing 13 gm of carbohydrate will be given orally, mixed in 200 ml of water and the drink will provide 52 Kcal energy.
This will be given only once to patient, 2 hours prior to the surgery, on the day of their surgery (duration of giving intervention agent - 2-3 minutes, as it takes to finish drinking). |
| Comparator Agent |
Sucrose powder |
13 gm of sucrose will be given orally, mixed in 200 ml of water, providing 52 Kcal energy. 2 Drops of lime juice will be mixed in it for antiemetic effect.
This will be given only once to patient, 2 hours prior to the surgery, on the day of their surgery (duration of giving comparator agent - 2-3 minutes, as it takes to finish drinking). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1. Age group 18-65 years
2. Patients undergoing elective, minor (level 2), intermediate (level 3) or high risk (level 4) abdominal surgeries involving upper and lower gastrointestinal tracts, hepatic resection or biliary reconstruction.
3. Patients undergoing inguinal, umbilical or incisional hernia repair.
4. All ASA1 and ASA 2 patients undergoing the above-mentioned surgeries who do not meet the exclusion criteria.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Patients having conditions that impair gastric emptying time – GERD, obesity, pregnancy, gastric outlet obstruction, intestinal obstruction, patients on certain pharmacological agents (like Morphine, tricyclic antidepressants, Levo-dopa) or patients who are unable to tolerate oral diet.
2. Patients having conditions affecting blood sugar level/ insulin level/ patient prone for dyselectrolytaemia – Diabetes Mellitus, Chronic Kidney Disease, Pancreatic tumor, or tumor involving pancreatic resection, adrenal insufficiency, or patients receiving colonic preparation prior to surgery.
3. Conditions that can affect the inflammatory markers- patients with sepsis, emergency procedures, and those undergoing oncological surgeries.
4. Patients undergoing very low risk (level 1) or very high risk (level 5) elective abdominal surgeries.
5. ASA 3, ASA 4 and ASA 5 patients.
6. Conditions that can affect glucose homeostasis- chronic liver disease, hyperthyroidism, HIV-AIDS, patients on steroid therapy.
7. Pregnant and lactating mothers.
8. Patients with BMI less than 18 or more than 30.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare insulin resistance between two groups- one receiving carbohydrate rich preparation and the other receiving coconut water preparation, using HOMA-IR method (Homeostatic Model Assessment- Insulin Resistance), LAP index (Lipid Accumulation Product index) and TyG index (Triglyceride -Glucose Index) – before and after carbohydrate loading. |
The outcome will be assessed at
- baseline (fasting) and
- 2 hours after pre-loading with the drink (post-prandial).
It will be assessed on the same day, 2 hours apart. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare C-Peptide levels before & after carbohydrate loading in two groups- one receiving carbohydrate rich preparation & the other receiving coconut water preparation.
2. To compare the psychosomatic status of the patients before & after receiving carbohydrate loading in the two groups using Visual Analogue Scale (VAS Scale) – anxiety, hunger, thirst, dryness of mouth, fatigue, headache, nausea, pain. |
The outcomes will be assessed at
- baseline (fasting) &
- 2 hours after pre-loading with the drink (post-prandial).
It will be assessed on the same day, 2 hours apart. |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2024 |
| Date of Study Completion (India) |
31/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
During any surgery, the surgical stress can cause decreased sensitivity of body cells towards insulin, resulting in insulin resistance and subsequent hyperglycemia. This upsets the inflammatory, endocrine and immunological homeostasis of the body and can result in various psychosomatic symptoms like pain, hunger, thirst, fatigue, anxiety etc. in the peri-operative period and in the post-operative period, it can result in prolonged hospital stay, readmission, increased surgical site infections etc. Various studies have shown that this insulin resistance can be significantly reduced by giving a carbohydrate rich drinks to patients, 2 hours prior to surgery, instead of making them fast overnight. In this randomized control trial, we hypothesize that coconut water is not inferior to the carbohydrate drinks that are typically used for carbohydrate loading in surgical patients in order to reduce peri-operative insulin resistance (non-inferiority trial). In this study, we plan to compare the difference between insulin resistance between 2 groups of patients who are posted for elective abdominal surgeries- one receiving carbohydrate rich drink and the other group receiving commercially prepared coconut water, 2 hours prior to surgery. Timed blood samples will be collected to measure serum insulin, blood glucose levels, C-peptide level at baseline (fasting) and 2 hours later after pre-loading them with carbohydrate drink or coconut water (post-prandial sample). Serum triglyceride will also be measured as fasting value. The derivatives of insulin resistance will be calculated as a primary outcome and will be compared using HOMA-IR (homeostatic model assessment for insulin resistance), LAP Index (lipid accumulation product index) and TyG Index (triglyceride glucose index). The psychosomatic status (like hunger, thirst, pain, anxiety, mouth dryness, nausea, headache) will be calculated as secondary outcome using VAS scores (visual analogue scale) at fasting and post-prandial levels. |