| CTRI Number |
CTRI/2021/08/035876 [Registered on: 24/08/2021] Trial Registered Prospectively |
| Last Modified On: |
13/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of magnesium sulphate versus dexmeditomidine as an adjuvant to ropivacaine for caudal block in paediatric surgeries : a prospective randomized double blind study. |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of magnesium sulphate versus dexmeditomidine as an adjuvant to 0.25% ropivacaine for caudal block in paediatric infraumbilical surgeries : a prospective randomized double blind study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRajan Anand |
| Designation |
Senior Consultant and head |
| Affiliation |
Sri Satya Sai Institute of Higher Medical Sciences Prasantigram |
| Address |
Room no 251 Sri Sathya Sai Institute of Medical Sciences Prasanthigram Anantapur
Room no 251 Sri Sathya Sai Institute of Medical Sciences Prasanthigram
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
8247238469 |
| Fax |
|
| Email |
rajan.a@sssihms.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJAN ANAND |
| Designation |
Senior Consultant, Head of the department |
| Affiliation |
Sri Satya Sai Institute of Higher Medical Sciences Prasantigram |
| Address |
Room no 251
SSSIHMSPG
Room no 251
SSSIHMSPG
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
9440699330 |
| Fax |
|
| Email |
rajan.a@sssihms.org.in |
|
Details of Contact Person
Public Query
|
| Name |
DR YENDETI AMRUTHA |
| Designation |
PRIMARY DNB ANAESTHESIA RESIDENT |
| Affiliation |
SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES |
| Address |
Sri Sathya Sai Institute of Medical Sciences,Department of Anaesthesiology, Prasanthigram, Anantapur, Andhra Pradesh,
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
9487739634 |
| Fax |
|
| Email |
yendeti_amrutha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sri Sathya Sai Institute of Medical Sciences, Prasanthigram, Anantapur, Andhra Pradesh, 515134
|
|
|
Primary Sponsor
|
| Name |
Dr YENDETI AMRUTHA |
| Address |
SSSIHMSPG |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR RAJAN ANAND |
Sri Sathya Sai Institute of Medical Sciences, Prasanthigram, Anantapur, Andhra Pradesh,515134
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR YENDETI AMRUTHA |
SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES |
Sri Sathya Sai Institute of Medical Sciences
Prasanthigram, Anantapur, Andhra Pradesh,515134
Anantapur
ANDHRA PRADESH |
9487739634
yendeti_amrutha@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES |
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 |
Caudal anesthesia |
Dexmeditomidine (1 ug/kg) as an adjuvant to 0.25% ropivacaine for caudal block
Magnesium sulphate(50mg) as an adjuvant to 0.25% ropivacaine for caudal block
|
| Comparator Agent |
Comparison of analgesic efficacy of magnesium sulphate versus dexmeditomidine as an adjuvant to 0.25% ropivacaine for caudal block. |
Dexmeditomidine (1 ug/kg) as an adjuvant to 0.25% ropivacaine for caudal block
Magnesium sulphate(50mg) as an adjuvant to 0.25% ropivacaine for caudal block
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
i. Children with informed written consent from their parents.
ii. Children posted for infra umbilical surgeries.
iii. American Society Anesthesiologists (ASA) physical status Grade I and II.
iv. Age between 2 to 10 years of either sex.
|
|
| ExclusionCriteria |
| Details |
i. Anatomical malformation of spine
ii. History of neurological and neuromuscular disorders.
iii. Coagulation abnormalities
iv. Patients with infection at local site.
v. Patients with known allergy to local anesthetics.
vi. Patient with bloody tap and dural puncture during caudal block
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
Post-operative analgesia will be monitored through The Face, Legs, Activity, Cry, Consolability (FLACC) pain score immediately with recovery, and every 30 min until the 2nd hour, then at the 4th, 6th, 12th,18th, and 24th hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemodynamic parameters(Heart rate (HR), Systolic BP(SBP), Diastolic BP(DBP) , Mean Arterial Pressure (MAP), SpO2, Respiratory rate(RR) )
2. Onset of analgesia
3. Residual motor block
4. Sedation score
5.To study the adverse effects such as nausea, vomiting, bradycardia ,hypotension, respiratory depression
|
Hemodynamic parameters will be monitored at 0, 15 and 30 min following caudal block, and at the end of surgery and Postoperatively every 30 min for first two hours, at 4,6,12,18 and 24th hour.
Post-operative analgesia, sedation and Residual motor blockade will be monitored immediately with recovery, and the 1st, 2nd, 3rd, 4th, 6th, 8th, 12th, 18th, and 24th hours postoperatively.
Adverse effects monitored and managed for 24 hrs.
|
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
31/08/2021 |
| 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
|
nil |
|
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 comparision of analgesic efficacy of magnesium sulphate versus dexmeditomidine as an adjuvant to 0.25% ropivacaine for caudal block in paediatric infra umblical surgeries: a prospective randomized double blind study that will be conducted in sri sathya sai institute of higher medical sciences . The primary outcome measures duration of analgesia ,secondary outcome will be to study the haemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure,mean arterial pressure,spo2,respiratory rate),onset of analgesia,residual motor block,sedation score,adverse effects such as nausea,vomiting,bradycardia,hypotension,respiratory depression. |