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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  
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 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  
Status 
Not Applicable 
 
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.

 
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