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CTRI Number  CTRI/2024/04/066031 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 05/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effect of preoperative carbohydrate water intake and perioperative multimodal pain medications on patient outcomes - A randomized controlled trial  
Scientific Title of Study   The effect of preoperative carbohydrate loading and perioperative opioid sparing multimodal analgesia on patient outcomes in Enhanced Recovery After Cardiac Surgery (ERACS) - A randomized 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  DrSathesh Kumar 
Designation  Senior resident 
Affiliation  cardiac anesthesia department Sree Chitra Tirunal Institute of Medical Science and Technology 
Address  cardiac anesthesia department, Sree Chitra Tirunal Institute of Medical Science and Technology, Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  07010008214  
Fax    
Email  spsathesh777@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Unni Krishnan K P 
Designation  Professor 
Affiliation  Cardiac anesthesia department Sree Chitra Tirunal Institute of Medical Science and Technology 
Address  Cardiac Anesthesia department, Sree Chitra Tirunal Institute of Medical Science and Technology, Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9446177521  
Fax    
Email  unnikp@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSathesh Kumar 
Designation  Senior resident 
Affiliation  Cardiac anesthesia department Sree Chitra Tirunal Institute of Medical Science and Technology 
Address  Sree Chitra Tirunal Institute of Medical Science and Technology, Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  07010008214  
Fax    
Email  spsathesh777@gmail.com  
 
Source of Monetary or Material Support  
Sree Chitra Tirunal Institute, Trivandrum 
 
Primary Sponsor  
Name  Sree Chitra Tirunal Institute of Medical Science and Technology 
Address  Sree Chitra Tirunal Institute of Medical Science and Technology, Trivandrum 
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 Sathesh Kumar P  Sree Chitra Tirunal institute of Medical science and technology  3rd floor,cardiology block,Department of Cardiac anesthesia
Thiruvananthapuram
KERALA 
7010008214

spsathesh777@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sree Chitra Tirunal Institute of Medical Science and Technology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I257||Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris, (2) ICD-10 Condition: I05-I09||Chronic rheumatic heart diseases, (3) ICD-10 Condition: I20-I25||Ischemic heart diseases, (4) ICD-10 Condition: O||Medical and Surgical, (5) ICD-10 Condition: I060||Rheumatic aortic stenosis, (6) ICD-10 Condition: I050||Rheumatic mitral stenosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clear water intake of 400ml before surgery.Routine standard analgesia plan as per institute protocol   Clear water intake of 400ml 2 hours before surgery.Routine standard analgesia plan as per institute protocol  
Intervention  Preoperative oral carbohydrate administration 2 hours before surgery. Opioid sparing multimodal analgesia  Maltodextrin powder is a carbohydrate powder commercially available and has been used in previous ERAS protocol studied worldwide and no adverse effects has been reported on usage. ERAS ( Enhanced recovery after surgery) recommends the maltodextrin for carbohydrate containing fluid intake before surgery. For multimodal analgesia, transverse thoracic plane (TTP) block, Dexmeditomedine, lignocaine, fentanyl, paracetamol have been used. Preoperative oral carbohydrate drink will be given 2 hours before surgery. multimodal analgesia regimen will be followed during surgery and for 48 hours postoperatively in the Intensive Care Unit 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients greater than 18 years of age undergoing elective cardiac surgeries either CABG (On pump and off pump) or valve surgeries.

 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1) The primary objective is the assessment of perioperative blood glucose level and insulin requirements in patients receiving oral clear carbohydrate containing fluid before surgery.   During the intraoperative period and 48 hours post surgery in the Intensive care Unit 
 
Secondary Outcome  
Outcome  TimePoints 
2) The secondary objectives are the inotropic and vasopressor requirements, post op ventilation time, length of ICU stay, duration of mechanical ventilation post operative arrhythmias, post operative pain score, pneumonia and surgical site infection.   48 hours perioperative period 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 3 
Date of First Enrollment (India)   01/07/2024 
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="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  

            ERAS (Enhanced Recovery After Surgery) is a multidisciplinary initiative to improve perioperative care, early discharge and reduce the cost of patients.1 ERAS protocol has already been well established in other surgeries like colorectal, gynecological surgeries and has been widely followed worldwide. There are several important components of ERAS include preop patient education, clear carbohydrate fluid intake in the morning and reduce fasting time, opioid sparing multimodal analgesia, post operative nausea prevention, early extubation and early mobilization. Among these components we have taken two most important components like clear carbohydrate fluid intake in the morning and reduce fasting time and opioid sparing multimodal analgesia, and planning to assess its effect on overall patient postoperative outcome. The studies have shown that preoperative oral carbohydrate intake reduces postoperative insulin resistance and improves glucose metabolism.2 It also helps in early return of gut function3, modifies hormonal and metabolic response, reduces surgical site infections and length of hospital stay. Preoperative oral carbohydrate intake 2 hours before general anesthesia is recommended as a part of Enhanced Recovery After Surgery (ERAS) pathway. But however it is not completely implemented in cardiac surgery due to varying level of evidences.4  ERAS protocol recommends to reduce the opioid usage and follow multimodal analgesia strategy.5 Transverse thoracic muscle plane (TTP) block is a new perioperative analgesic method for post sternotomy discomfort. For patients undergoing heart surgery, TTP block offers sufficient postoperative pain control, resulting in lower pain scores, lower postoperative analgesic doses, shorter  extubation times, and shorter ICU stay lengths.6 TTP block reduces the perioperative  opioid consumption and  the incidence of nausea and vomiting.7,8 Lidocaine is a widely available and commonly used local anaesthetic. When administered intravenously it demonstrates anti hyperalgesic properties that improve acute postoperative pain management. Lignocaine also decreases the MAC (Minimal Alveolar Concentration) of volatile agents, reduces analgesic consumption and better analgesia.9 Lignocaine infusion for pain has been widely accepted and implemented in colorectal  ERAS protocol.10 Now it needs to be implemented in cardiac surgery for better analgesia. Similarly Dexmeditomedine  infusion provides better analgesia and reduces opioid  usage in the perioperative period.11 So, preoperative carbohydrate loading with opioid sparing multimodal analgesia improves outcome in patients undergoing cardiac surgery.

 
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