| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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. |