| CTRI Number |
CTRI/2024/07/069976 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Recovery of patients receiving preoperative carbohydrate drink and undergoing total knee replacement surgery |
|
Scientific Title of Study
|
Effect of Carbohydrate Loading on Recovery of Patients undergoing Total Knee Replacement Surgery- A Randomised controlled 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 |
Sana Yasmin Hussain |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesia
5th floor
Teaching Block
AIIMS
South DELHI 110076 India |
| Phone |
09769144164 |
| Fax |
|
| Email |
drhussainsana17@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sana Yasmin Hussain |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesia
5th floor
Teaching Block
AIIMS
South DELHI 110076 India |
| Phone |
09769144164 |
| Fax |
|
| Email |
drhussainsana17@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sana Yasmin Hussain |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesia
5th floor
Teaching Block
AIIMS
South DELHI 110076 India |
| Phone |
09769144164 |
| Fax |
|
| Email |
drhussainsana17@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi, India
110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Ansari Nagar
New Delhi
India
110029 |
| 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 Sana Yasmin Hussain |
All India Institute of Medical Sciences, New delhi |
Department of anesthesia and orthopedics
Ortho OT South DELHI |
97691441664
drhussainsana17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
carbohydrate drink used will be Surgicarb |
Volume – 355 ml
Surgicarb drink will be given dau before and morning of surgery. compopsition includes: Total calories - 200
Total carbohydrate – 50g
Sodium – 180 mg
Potassium -45 mg
|
| Comparator Agent |
non-caloric drink |
non-caloric drink similar in taste by mixing artificial sweetener in water, 355 ml on morning and day before surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
After obtaining institute ethical clearance and informed written consent from all patients, the study will be conducted in ASA 1-2 patients who are posted for unilateral Total Knee Replacement surgery in 70 patients ages 18-70 years
|
|
| ExclusionCriteria |
| Details |
Diabetes, obesity, reflux disease, patient on steroids, severe cardiac or renal disease |
|
|
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 |
| Well-being of the patients – assessed using Numerical Rating Scale for Pain, Thirst and Hunger, weakness. |
preoperatively, 4 hrs and 24 hrs postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Insulin resistance and inflammatory markers (cortisol and IL-6)
2. Incidence of post-operative nausea and vomiting
3. The Post-operative cumulative ambulation score (CAS) - To assess basic mobility in postoperative period
|
preoperatively, 4 hrs and 24 hrs postoperatively |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/07/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Recent evidence shows the advantages of carbohydrate loading in major surgeries especially gastrointestinal surgeries. The pathophysiological and metabolic changes in response to surgery can be diminished by introducing ways of decreasing inflammatory and metabolic response including insulin resistance. Patients undergoing total knee replacement surgeries are at a high risk for developing perioperative metabolic derangements and complications due to the advanced age and associated comorbidities. We expect that a simple measure like decreasing the fasting time and carbohydrate loading will decrease the metabolic and endocrine derangements by decreasing the insulin resistance, decreasing the inflammatory response. It will also decrease patient discomfort by reducing thirst, dehydration, hunger, pain and anxiety. Reduced protein catabolism will lead to improved muscle strength, decreased weakness and help in early ambulation. Positive outcomes of the study will encourage introduction of a simple, efficacious and inexpensive clinical intervention in patients undergoing this major orthopedic surgery which demands early recovery and ambulation. Patients will have increased satisfaction without the risk of aspiration, decreased post-operative complications leading to early discharge and reduced length of hospital stay. |