| CTRI Number |
CTRI/2025/03/081773 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing Carbohydrate vs. Non-Carbohydrate Clear fluids before Abdominal Surgery |
|
Scientific Title of Study
|
Implementation of enhanced recovery after surgery [ERAS] for comparing the preoperative administration of carbohydrate containing versus non carbohydrate containing clear fluid in patients undergoing abdominopelvic onco-surgery: A 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 Soumya Thakur |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology, 3rd floor, AIIMS Bhopal Campus, Saket Nagar, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9456533827 |
| Fax |
|
| Email |
thakur2soumya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Waindeskar |
| Designation |
Professor and Head of Department |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology, 3rd floor, AIIMS Bhopal Campus, Saket Nagar, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9575604490 |
| Fax |
|
| Email |
vaishali.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Waindeskar |
| Designation |
Professor and Head of Department |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology, 3rd floor, AIIMS Bhopal Campus, Saket Nagar, Bhopal, Madhya Pradesh
MADHYA PRADESH
462020
India |
| Phone |
9575604490 |
| Fax |
|
| Email |
vaishali.anesth@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhopal, Madhya Pradesh, India 462020 |
|
|
Primary Sponsor
|
| Name |
AIIMS BHOPAL |
| Address |
AIIMS Bhopal, Saket Nagar, Bhopal, Madhya Pradesh, India 462020 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Soumya Thakur |
AIIMS Bhopal |
Department of Anaesthesiology, Modular OT Complex 3rd floor, AIIMS Bhopal Campus, Saket Nagar, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH |
9456533827
thakur2soumya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Bhopal Institutional Human Ethics Committee- Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Carbohydrate Loading clear fluid |
Pre operative loading two hours before surgery with carbohydrate containing clear fluids compared to the routinely practiced fasting |
| Comparator Agent |
Non carbohydrate loading clear fluid |
Pre operative loading with non-carbohydrate containing clear fluids - water two hours before surgery, compared to the routinely practiced fasting |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective abdominopelvic tumour surgery with anaesthesia time more than 3 hours
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patients with Diabetes Mellitus
3. Non- oncologic surgeries
4. Pregnant patients
5. Emergency surgeries
6. Any cause of delayed gastric emptying
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The effectiveness of different carbohydrate loading strategies on patient stress by measuring serum cortisol on the day of surgery and POD1.
2.Comparison of the impact of carbohydrate loading on quality of recovery.
a) Number of days of hospital stay in post operative period,
b) QOR15 score on POD1 and on the day of discharge
|
Day of surgery, Post operative day 1 and day of discharge
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To monitor perioperative blood glucose in patients undergoing different carbohydrate loading protocols at T1,
2. Hemodynamic monitoring (Heart rate, Systolic, diastolic and mean arterial pressure) at T0, T1, and every 15 minutes
3. Incidence of post operative nausea and vomiting
|
T0 : baseline, T1: prior to induction, T2: 5 minutes post induction, thereafter every 15 minutes till the end of the surgery |
|
|
Target Sample Size
|
Total Sample Size="117"
Sample Size from India="117"
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)
|
25/03/2025 |
| 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="1"
Months="6"
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 - NO
|
|
Brief Summary
|
ERAS focuses on evidence-based interventions that aim to reduce hospital stays, enhance patient recovery, and decrease healthcare costs by optimizing patient physiology throughout the surgical process. Given the impact of preoperative nutrition on surgical outcomes, this study seeks to evaluate the effect of preoperative carbohydrate loading via clear fluids administered two hours before surgery. Written and informed consent will be obtained from all the patients fulfilling the inclusion criteria by explaining the details of study in their own language in the presence of a witness. A computer-generated randomisation of the selected patients according to the inclusion criteria, and group will be assigned: Group A, Group B and Group C, where 1. Group F : Fasting group 2. Group W : 200 ml Water 120 minutes prior to surgery 3. Group C : 200 ml Carbohydrate rich drink 120 minutes prior to surgery Bowel preparation, and preoperative placement of nasogastric tube will be discussed with the concerned surgeon. Fasting and carbohydrate loading guidelines will be explained to the patient in the routine review pre-anaesthesia checkup on the evening prior to surgery. - Normal diet until midnight (6-8 hours prior to surgery),
- clear liquids until 2 h before surgery,
- 200 ml of clear fluid will be given by the anaesthesia resident ward according to the allocated group of the patient as per the computerised blocked randomisation list.
At 8am on Day of surgery an intravenous cannula will be placed as routine requirement of elective surgery, 3 ml of blood sample for Serum cortisol will be drawn. A fasting value of Blood sugar will be checked. The baseline hemodynamic parameters : HR, SBP, DBP, MAP will be noted at this time. (T0) The concerned anaesthesiologist conducting the perioperative anaesthesia management and observation of parameters will be blinded to the allotted groups of the patient. |