| CTRI Number |
CTRI/2024/07/069738 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the safety and efficacy of Pre Operative oral carbohydrate drink vs plain Water in paediatric patients undergoing elective surgeries under General Anaesthesia |
|
Scientific Title of Study
|
Safety and efficacy of pre operative oral carbohydrate drink in paediatric patient undergoing elective surgeries under general anaesthesia a randomized control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarv Priya Singh |
| Designation |
PG Resident |
| Affiliation |
Pt JNM Medical College Raipur |
| Address |
Department of Anaesthesiology and Pain Medicine, Major Operation theatre, Dr BRAM Hospital, Pt JNM Medical College Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
7042734749 |
| Fax |
|
| Email |
sarvpriya29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratiksha Agrawal |
| Designation |
Associate Professor |
| Affiliation |
Pt JNM Medical College Raipur |
| Address |
Department of Anaesthesiology and Pain Medicine Pt JNM Medical College Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
8815155558 |
| Fax |
|
| Email |
dr.pratiksha.agrawal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarv Priya Singh |
| Designation |
PG Resident |
| Affiliation |
Pt JNM Medical College Raipur |
| Address |
Department of Anaesthesiology and Pain Medicine, Major Operation Theatre , Dr BRAM Hospital, Pt JNM Medical College Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
7042734749 |
| Fax |
|
| Email |
sarvpriya29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Pain Medicine, Pt JNM Medical College Raipur Chhattisgarh- 492001 India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Pain Medicine Pt JNM Medical College Raipur |
| Address |
Department of Anaesthesiology and Pain Medicine Pt JNM Medical College Raipur Chhattisgarh-492001
India |
| Type of Sponsor |
Government 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 |
| Dr Sarv Priya Singh |
Dr Bhimrao Ambedkar Memorial Hospital Raipur |
Department Of Anaesthesiology and Pain Medicine/Major OT/ Pt JNM Medical College Raipur
Raipur
CHHATTISGARH |
7042734749
sarvpriya29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt JNM Medical College Raipur CG |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (2) ICD-10 Condition: Q10-Q18||Congenital malformations of eye, ear, face and neck, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dextrose 5% |
Group I (Study group) will receive 10 ml per kg of Dextrose 5% in water 2 hour before the surgery |
| Comparator Agent |
Plain Water |
Group II (Control group) will receive 10 ml per kg of Plain water 2 hour before the surgery |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I to II
Patients undergoing elective Surgery under GA following standard NPO guidelines
|
|
| ExclusionCriteria |
| Details |
Parental refusal
Children uncooperative for undergoing USG
Gastric volume greater than 1.5ml per kg at T0
Patient requiring intravenous maintenance fluids
Abdominal surgeries
Known case of Gastroesophageal reflux or Gastritis
Diagnosed case of Hiatus hernia
History of gastrointestinal surgeries
Enteropathies
Esophageal motility disorder
Use of any medication that effects gastric secretion or emptying within the past 24 hours
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pre – operative gastric volume 2h after oral intake of study solution
Parental satisfaction score
Degree of Thirst using VAS Score
Degree of irritability using VAS Score
Degree of hunger using VAS Score
Degree of anxiety using modified yale preoperative anxiety scale.
Number & duration of surgeries delayed due to high gastric volume
Side effects and complications (nausea, vomiting, aspiration pneumonitis, agitation )
|
The Time of oral drink given will be noted and investigator will note outcome variables 2hours after the drink is given. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Degree of anxiety using modified yale preoperative anxiety scale.
Number & duration of surgeries delayed due to high gastric volume
Side effects and complications (nausea, vomiting, aspiration pneumonitis, agitation ) |
Outcome variables at for 2 hours will be noted and upto 24 hours for complications, if any. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
08/07/2024 |
| 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
|
Group I study group will receive 10ml/kg of 5% dextrose in water and Group II control group will receive 10ml/kg of plain water 2 hours after surgery. Gastric volume (GV) will be assessed at T0(before giving drink) and T2( 2hours after giving drink). If GV<1.5ml/kg patient will be taken up for surgery. Parental Satisfaction score(1-5) and VAS(1- 10) for hunger, thirst and irritability will be assessed after T2. |