| CTRI Number |
CTRI/2024/11/076559 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of giving sugar containing fluid on stomach contents during anaesthesia |
|
Scientific Title of Study
|
Impact of pre-operative carbohydrate loadingon gastric residual volume in patients undergoing major abdominal surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshmi Kumar |
| Designation |
Professor and Head |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Ernakulam
KERALA
682041
India |
| Phone |
09496211333 |
| Fax |
914842852020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakshmi Kumar |
| Designation |
Professor and Head |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
KERALA
682041
India |
| Phone |
09496211333 |
| Fax |
914842852020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
CelestinaJohn Christraj |
| Designation |
Postgraduate student |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Tower 6 Floor 1
AIMS Kochi
Ernakulam
KERALA
682041
India |
| Phone |
8300887055 |
| Fax |
914842852020 |
| Email |
celestinajcs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute Of Medical Sciences
Edapally
Kochi 682041 |
|
|
Primary Sponsor
|
| Name |
Amrita Institute Of Medical Sciences |
| Address |
Department of Anaesthesia
Tower 6 Floor 1
Kochi 682041 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Lakshmi Kumar |
Amrita Institute Of Medical Sciences |
Department of Anaesthesia and Critical care
Tower 6 Floor 1
AIMS Kochi
Ernakulam
KERALA |
9496211333
914842852020
lakshmi.k.238@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Patients will be fasted for 8 hours prior to surgery |
| Intervention |
Pre-operative maldodextrin drink two hours before surgery |
A sachet with 50 g maltodextrin is dissolved in 400 ml water and the patients intructed to consume this over 15 minutes to finsih before 2 hours prior to the surgery alloted time |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
72.00 Year(s) |
| Gender |
Both |
| Details |
Elective adult patients presenting for abdominal surgery without contraindications for oral carbohydrate loading |
|
| ExclusionCriteria |
| Details |
1. Full stomach patients
2. Vomiting
3.Gastro-esophaeal reflux/hiatus hernia
4.Bowel obstruction
5. Advanced liver/ renal disease/ DM with gastroparesis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of gastric residual volumes measured by ultrasound between patients who receive oral maldodextrin preoperatively versus fasted patients undergoing major abdominal surgery |
Pre induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Volume of gastric aspirate
Secretions in the mouth at intubation |
After insertion of Ryles tube following intubation
At laryngoscopy |
|
|
Target Sample Size
|
Total Sample Size="456"
Sample Size from India="456"
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)
|
29/11/2024 |
| 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) |
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
|
Preoperative carbohydrate loading is being introduced as part or ERAS guidelines. The safety of administration of 400 ml liquid on the residual gastric volume is unclear and this limits the use of this strategy among surgical patients. This aims at measurement of the residual gastric volume in patients given the drink versus controls to establish its safety in clinical practice |