| CTRI Number |
CTRI/2025/02/080208 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Examining the effects of Pre surgery nutrition on blood sugar control in patients undergoing laparoscopic gall bladder removal surgery |
|
Scientific Title of Study
|
The Impact of Preoperative Branched Chain Amino Acid Overloading on Insulin Resistance compared to Carbohydrate Overloading and Conventional Fasting in patients undergoing Laparoscopic Cholecystectomy An Open Labelled Randomised 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 Baddala Santhosh Reddy |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery
All India Institute of Medical Sciences Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
7730958179 |
| Fax |
|
| Email |
santhoshbaddala5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Gupta |
| Designation |
Associate Professor of Surgery |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery
All India Institute of Medical Sciences Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9453302264 |
| Fax |
|
| Email |
ravikgmc2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Gupta |
| Designation |
Associate Professor of Surgery |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery
All India Institute of Medical Sciences Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9453302264 |
| Fax |
|
| Email |
ravikgmc2004@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery
All India Institute of Medical Sciences Kunraghat Gorakhpur
Uttar Pradesh Country India Pincode 273008 |
|
|
Primary Sponsor
|
| Name |
Dr Baddala Santhosh Reddy |
| Address |
All India Institute of Medical Sciences Gorakhpur
GORAKHPUR
Uttar Pradesh
273008
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Baddala Santhosh Reddy |
All India Institute of Medical Sciences Gorakhpur |
Department of General Surgery
All India Institute of Medical Sciences Gorakhpur
Gorakhpur
UTTAR PRADESH
Gorakhpur
UTTAR PRADESH |
7730958179
santhoshbaddala5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee All India Institute of Medical Sciences Gorakhpur India |
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 |
| Comparator Agent |
Carbohydrate Overloading |
Patients in this group will be given 400 ml of carbohydrates (296 ml/bottle pre-operative carbohydrate overloading drink: - 50 g of carbohydrate, 200 calories) preload 8 hours before surgery and 200 ml of Carbohydrate Preload 2-4 hours prior to laparoscopic cholecystectomy.
Duration of Intervention :-
Patients will be given Carbohydrate drink 8 hrs before surgery and at 2-4 hours before surgery and patient will drink the solution within 10 mins after giving the solution |
| Comparator Agent |
Conventional Fasting |
Patients in this group will undergo conventional fasting from midnight/8 hrs prior to laparoscopic cholecystectomy according to guidelines |
| Intervention |
Preoperative branched chain amino acid overloading |
Patients in this group will be given 2 sachets of BCAA (13 mg of BCAA with each sachet containing L-Isoleucine 1.2 gm, L-Leucine 2.3 gm, L-Valine 1.5 gm) in 400 ml water 8 hours before surgery and 1 sachet of BCAA (6.5 mg) in 200 ml water 2-4 hours prior to laparoscopic cholecystectomy.
Duration of Intervention :-
Branched chain Amino Acids containing solution is given 8 hrs before surgery and at 2-4 hours before surgery and patient will drink the solution within 10 mins after giving the solution. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients aged 18 years and older
2.Patients scheduled for elective laparoscopic cholecystectomy
3.BMI within 18.5 – 29.9 kg/m2
4.ASA – PS Classification I or II
5.Willingness to comply with study protocols, including preoperative fasting & BCAA and carbohydrate administration
6.Patients who provide informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1.Patients with pre-existing metabolic disorders like Diabetes, Obesity or any systemic illness that affects Glucose metabolism
2.Previous history of surgery on the oesophagus or stomach
3.Patients with symptoms related to severe GERD or Hiatal hernia
4.Patients with abnormal fasting blood glucose (more than 110 mg/dl)or insulin levels(more than 24.9 U/ml) prior to surgery
5.Chronic Liver Disease /Chronic Kidney Disease /Chronic Endocrine disorders that may affect glucose or amino acid metabolism
6.Pregnant or Breast-Feeding women
7.Use of Insulin/OHA/Medications affecting glucose metabolism within recent period
8.Use of Protein/Amino acid supplements within recent period
9.Conversion to open surgery and bail out procedure will be excluded
10.Patients with cognitive impairment or inability to provide informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Pre-operative Branched Chain Amino Acid Overloading on Post-operative Insulin Resistance and Post-Operative Hyperglycaemia in patients undergoing elective laparoscopic cholecystectomy. The primary endpoint will be the successful demonstration of effect of BCAA preloading compared to carbohydrate overloading and conventional overnight fasting on Post-operative Insulin Resistance and post-operative hyperglycaemia |
Primary Outcomes will be assessed 12-15 hours before surgery, 1 hour before induction of anesthesia on day of surgery and post operatively on 10th Hour after completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the Incidence of hyperglycaemia related complications such as Post Operative Hunger, Thirst , Anxiety, Fatigue, Post Operative Nausea & Vomiting ,Prolonged Hospital Stay, Post Operative Pain, Surgical Site Infection, Bowel function recovery |
All patients will be followed in post operative period on Day 0 Day 1 Day 2 at time of discharge & at 90 days post surgery. |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Insulin resistance after surgery is a known issue that can lead to complications like hyperglycemia, prolonged recovery, nausea, vomiting, pain, surgical site infections, and longer hospital stays. The study aims to investigate whether BCAA preloading before surgery can help reduce these risks more effectively than carbohydrate preloading or fasting and to evaluate the effects of preloading with Branched Chain Amino Acids compared to carbohydrate preloading and conventional fasting on postoperative insulin resistance and hyperglycemia in patients undergoing elective laparoscopic cholecystectomy. The trial will take place at the All India Institute of Medical Sciences (AIIMS) in Gorakhpur, India, and will span over two years. The first 18 months will focus on enrolling patients, carrying out interventions, and conducting follow-up assessments, while the final 6 months will be dedicated to data analysis and report writing. During this period, adult patients who are scheduled for elective laparoscopic cholecystectomy that satisfy inclusion criteria and does not meet the exclusion criteria will be enrolled. Participants will be randomly assigned to one of three groups: Branched Chain Amino Acids, Carbohydrate, or Conventional fasting. The study will assess the impact on various postoperative outcomes, including insulin resistance, hyperglycemia, postoperative nausea and vomiting, pain, surgical site infections , recovery of bowel function, and length of hospital stay.By comparing these three approaches, the study aims to determine whether BCAA preloading can improve post-surgical recovery by mitigating insulin resistance and hyperglycemia, ultimately leading to fewer complications and a quicker recovery. |