| CTRI Number |
CTRI/2024/09/073257 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A research study comparing 2 medications, which is given before surgery
in pediatric patients, to compare its benefits during and after surgery |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine versus Gabapentin as premedication in pediatric age group:
A randomized control 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 |
Dr Anusha R |
| Designation |
Junior resident PG student |
| Affiliation |
AIIMS Raebareli |
| Address |
Dept of Anesthesiology and critical care
2ND floor Main hospital building AIIMS Raebareli
Dalmau road Munshi Ganj Raebareli
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
6238837159 |
| Fax |
|
| Email |
anusharemavaran1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalicharan Das |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Raebareli |
| Address |
Dept of Anesthesiology and critical care
2ND floor Main hospital building AIIMS Raebareli
Dalmau road Munshi Ganj Raebareli
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
9643023419 |
| Fax |
|
| Email |
kalimbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalicharan Das |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Raebareli |
| Address |
Dept of Anesthesiology and critical care
2ND floor Main hospital building AIIMS Raebareli
Dalmau road Munshi Ganj Raebareli
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
9643023419 |
| Fax |
|
| Email |
kalimbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of medical science Raebareli Uttar Pradesh 229405 |
|
|
Primary Sponsor
|
| Name |
AIIMS Raebareli |
| Address |
AIIMS Raebareli Dalmau Road Munshiganj Raebareli
UP 229405 |
| 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 Anusha R |
Aiims Raebareli |
Dept of Anesthesiology and critical care
2ND floor Main hospital building AIIMS Raebareli
Dalmau road Munshi Ganj Raebareli
Rae Bareli
UTTAR PRADESH |
6238837159
anusharemavaran1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitionsl Ethics committee AIIMS Raebareli |
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 |
| Intervention |
Dexmedetomidine and Gabapentin as premedication |
All the patients aged 4-10 yrs. who are posted for elective surgeries will be undergoing routine pre-anesthetic checkup according to institute protocol. Patient eligibility screening will be conducted during pre-anesthetic checkup at least a day before surgery. After obtaining parent consent and ethical committee approval, children accompanied by one parent, will be taken to the pre-operative room. Parents will be informed about the benefits of usage of pre-medication, and written informed consent will be obtained from those opting to participate in the study. The eligible patients will be randomized to two groups: Group D – Dexmedetomidine and Group G -Gabapentin. The randomization allocations will be done by concealed seal envelopes. Baseline heart rate and SpO2 will be documented. The calculated dose for each patient will be given 30 minutes before anesthesia induction. After the administration of premedication, SpO2 and heart rate will be monitored at 5-minute intervals for a duration of 30 minutes.. Before shifting the patient to operating theater, each patient will be assessed for the degree of sedation using Ramsay Sedation Score at preoperative area. The Ramsay sedation score is graded from 1 to 6 as patient anxious and or agitated patient cooperative and oriented patient only responds to orders a brisk response to a light glabellar tap or loud auditory stimulus a sluggish response no response. |
| Comparator Agent |
Dexmedetomidine will be given transnasally |
Dexmedetomidine 2 mcg/kg, in a single dose, a preparation of 100mcg/ml, administrated as intranasal drops ,evenly divided between each nostril, with the child in their mothers lap, facilitated by a tuberculin syringe. Spo2 and heart rate will be monitored at 5minute intervals for a duration of 30 minutes. . Before shifting the patient to operating theater, each patient will be assessed for the degree of sedation using Ramsay Sedation Score at preoperative area. The Ramsay sedation score is graded from 1 to 6 as patient anxious and or agitated patient cooperative and oriented patient only responds to orders a brisk response to a light glabellar tap or loud auditory stimulus a sluggish response no response. patient
will be observed for a duration of 24 hours postoperatively |
| Comparator Agent |
Gabapentin will be given orally |
Gabapentin in a dose of 15 mg/kg as single dosage will be administered as oral medication. Spo2 and heart rate will be monitored at 5minute intervals for a duration of 30 minutes. . Before shifting the patient to operating theater each patient will be assessed for the degree of sedation using Ramsay Sedation Score at preoperative area. The Ramsay sedation score is graded from 1 to 6 as patient anxious and or agitated patient cooperative and oriented patient only responds to orders a brisk response to a light glabellar tap or loud auditory stimulus a sluggish response no response. patient will observed for a duration 24 hours postoperatively |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
All patient of ASA grade 1 and 2 aged from 4- 10 years who are undergoing elective surgeries not more than 2 hours under general anesthesia will be included |
|
| ExclusionCriteria |
| Details |
1.Children with any behavioral or neurological
abnormalities
2.Hypersensitivity to Dexmedetomidine or
Gabapentin
3.Respiratory tract infection within 2 weeks
4.Children already under any sedative medications
or analgesics
5.Under any antiepileptic medication
6.Pulmonary, renal, cardiac or hepatic
insufficiency
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of Dexmedetomidine and Gabapentin premedication in inducing sedation using Ramsay Sedation Scale in elective surgeries not more than 120 minutes |
30 minutes after administration of drug, before shifting the patient to operation theatre |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Parental satisfaction score
postoperative pain score using FLACC Scale
postoperative sedation using Ramsay sedation score
postoperative nausea and vomiting
Emergence delirium using PAED Score
|
24 hours |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2024 |
| 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="1" |
|
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
|
This study is a Randomized control trial, comparing the efficacy of Dexmedetomidine and Gabapentin as premedication in pediatric patients aged 4-10 years ,that is being conducted in AIIMS Raebareli. The primary outcome is to compare the effectiveness of these drugs in inducing sedation in preoperative area |