| CTRI Number |
CTRI/2024/02/063210 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The Effect of pregabalin in pediatric
infraumblical abdominal surgery |
|
Scientific Title of Study
|
Effect of pregabalin premedication on emergence agitation in pediatric infraumblical abdominal surgery after sevoflurane anesthesia , double blinded, randomized placebo 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 Himanshi |
| Designation |
PG Junior Resident |
| Affiliation |
All India institute of medical sciences , Raipur |
| Address |
Office of Anesthesia, Department of Anaesthesiology , B Block 4th Floor ,All India institute of medical sciences , Tatibandh ,Raipur
Chhattisgarh
492099
India
Raipur
CHHATTISGARH
492099
India |
| Phone |
7897200181 |
| Fax |
|
| Email |
himanshichauhan091@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subrata Kumar Singha |
| Designation |
Professor |
| Affiliation |
All India institute of medical sciences, Raipur |
| Address |
Department of Anaesthesiology , B Block 4th Floor ,All India institute of medical sciences , Tatibandh ,Raipur
Chhattisgarh
492099
India
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881767 |
| Fax |
|
| Email |
subratsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subrata Kumar Singha |
| Designation |
Professor |
| Affiliation |
All India Institute of medical sciences, Raipur |
| Address |
Department of Anaesthesiology , B Block 4th Floor ,All India institute of medical sciences , Tatibandh ,Raipur
Chhattisgarh
492099
India
Raipur
CHHATTISGARH
492099
India |
| Phone |
8518881767 |
| Fax |
|
| Email |
subratsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of medical sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
All India institute of medical sciences Raipur |
| Address |
Office of Anesthesia, Department of Anaesthesiology , B Block 4th Floor ,All India institute of medical sciences , Tatibandh ,Raipur
Chhattisgarh
492099
India |
| 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 Himanshi |
All India institute of medical sciences Raipur |
Paediatric OT, Department of Anaesthesiology , B Block 4th Floor ,All India institute of medical sciences , Tatibandh ,Raipur
Chhattisgarh
492099
India
Raipur
CHHATTISGARH |
7897200181
himanshichauhan091@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: R448||Other symptoms and signs involvinggeneral sensations and perceptions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo(Sugar syrup) |
Children will receive oral placebo sugar syrup once (Group C) We will record pain, and complications as postoperative EA scale (EAS) (10, 20, and 30 min postoperatively), time to open the eye, time to extubate, postanesthe-sia care unit (PACU) duration of stay, number of paracetamol doses (15 mg/kg) given (to control postoperative vomiting and dizziness on discharge) |
| Intervention |
Pregabalin |
Effect of pregabalin premedication, Children will receive oral pregabalin syrup 1.5 mg/kg (Group P) 1â„2 h preoperatively once We will record postoperative EA scale (EAS) (10, 20, and 30 min postoperatively), time to open the eye, time to extubate, postanesthesia care unit (PACU) duration of stay, number of paracetamol doses (15 mg/kg) given (to control postoperative pain), and complications as vomiting and dizziness on discharge. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1 Age: 4-12years
2 mASA physical status
3 Child undergoing Infraumblical Abdominal surgery |
|
| ExclusionCriteria |
| Details |
1 Patient’s parent’s refusal
2 History of developmental delay or mental
retardation,which will make observational pain
intensity assessment difficult
3 Anatomical abnormalities
4 Bleeding diathesis
5 Coagulation disorder
6 History of renal,hepatic,cardiac disorder upper or
lower infection or any neurological abnormalities
7 Emergency cases
8 Cerebral palsy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oral pregabalin premedication is effective in Emeregence Agitation after Sevoflurane anesthesia
in Infraumblical abdominal surgeries. |
Day 0 at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
04/03/2024 |
| 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 Yet Recruiting |
| 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
|
Emergence agitation (EA) is a temporary condition that occurs while awaking from general anesthesia.
Sevoflurane is very valuable for induction and continuation of anesthesia in pediatrics, but it is correlated with increased ratio of EA.
Medications used to prevent EA may have unwanted adverse effects such as vomiting and delayed recovery.
Pregabalin belongs to gabapentinoid compounds with anticonvulsant, pain killing, and antianxi-ety activity. The target of this study is to define the influence of pregabalin premedication in pe- diatrics on EA after sevoflurane anesthesia. |