| CTRI Number |
CTRI/2023/02/049660 [Registered on: 13/02/2023] Trial Registered Prospectively |
| Last Modified On: |
11/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To assess the effectiveness of adding Dexmedetomidine (a drug) to Ropivacaine (a local anaesthetic drug),compared to Ropivacaine alone, for pain relief in pediatric surgeries below the umbilicus. |
|
Scientific Title of Study
|
To compare the effectiveness of Dexmedetomidine with Ropivacaine and Ropivacaine alone for caudal epidural analgesia in pediatric infraumbilical surgeries in a tertiary care center in Kerala |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alvi Vinod |
| Designation |
PG Resident |
| Affiliation |
Pushpagiri Institute of Medical Sciences and Research Center, Thiruvalla |
| Address |
Department of Anaesthesiology, Pushpagiri Institute of Medical Sciences and Research Center, Thiruvalla.
Vellakkattel House, Kizhakombu P.O., Koothattukulam - 686662, Ernakulam district, Kerala.
Pathanamthitta
KERALA
689101
India |
| Phone |
8281377694 |
| Fax |
|
| Email |
alvivinod123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mary AD |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Pushpagiri Institute of Medical Sciences and Research Center, Thiruvalla |
| Address |
Department of Anaesthesiology, Pushpagiri Institute of Medical Sciences and Research Center, Thiruvalla.
Arthasseril House, Doctors Garden, Gandhinagar P.O., Kottayam- 686008, Kerala
Pathanamthitta
KERALA
689101
India |
| Phone |
9495685155 |
| Fax |
|
| Email |
drmaryalbert@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alvi Vinod |
| Designation |
PG Resident |
| Affiliation |
Pushpagiri Institute of Medical Sciences and Research Center, Thiruvalla |
| Address |
Department of Anaesthesiology, Pushpagiri Institute of Medical Sciences and Research Center, Thiruvalla.
Vellakkattel House, Kizhakombu P.O., Koothattukulam- 686662, Ernakulam district, Kerala.
Pathanamthitta
KERALA
689101
India |
| Phone |
8281377694 |
| Fax |
|
| Email |
alvivinod123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pushpagiri Institute of Medical Sciences and Research Center, Thiruvalla
|
|
|
Primary Sponsor
|
| Name |
Dr Alvi Vinod |
| Address |
Dr. Alvi Vinod, PG Resident,
Department of Anaesthesiology, Pushpagiri Institute of Medical Sciences and Research Center, Thiruvalla
|
| Type of Sponsor |
Other [Self] |
|
|
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 Alvi Vinod |
Pushpagiri Institute of Medical Sciences and Research Center, Thiruvalla |
Department of Anaesthesiology
Pathanamthitta
KERALA |
8281377694
alvivinod123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pushpagiri Institute of Medical Sciences and Research Center, Thiruvalla |
Approved |
|
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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 |
Ropivacaine |
0.25% Ropivacaine (1ml/kg), single bolus dose, is given for Caudal Epidural Block, during intraoperative and postoperative period of paediatric infraumbilical surgeries. |
| Comparator Agent |
Ropivacaine with Dexmedetomidine |
0.25% Ropivacaine (1ml/kg) with Dexmedetomidine (1microgram/kg), single bolus dose, is given for Caudal Epidural Block, during intraoperative and postoperative period of paediatric infraumbilical surgeries. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA class 1 & 2
2. Children undergoing elective infraumbilical surgery less than 1hour duration |
|
| ExclusionCriteria |
| Details |
1. Known allergy to the study drugs
2. Suspected coagulopathy
3. Infection at the site of block
4. History of developmental delay, neurological disease, skeletal deformities, cardiovascular diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia assessed by Modified Objective Pain Score greater than 4 |
10minute interval for first half an hour and then at 1,2,4,6,8,12,18,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Emergence time |
Time from end of surgery to opening of eyes spontaneously or on calling. |
| Sedation using Simple sedation score |
10minute interval for first half an hour and then at 1,2,4,6,8,12,18,24 hours |
| Duration of motor block |
From time of block to time of spontaneous leg movements |
| Heart rate, Mean Arterial Pressure, Respiratory rate, SpO2 |
Intraoperatively, every 5minutes for the 1st half an hour and then at 10minute intervals.
Postoperatively, 10minute interval for first half an hour and then at 1,2,4,6,8,12,18,24 hours. |
|
|
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)
|
15/02/2023 |
| 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
|
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 unicentric observational study to compare the effectiveness of Dexmedetomidine with Ropivacaine and Ropivacaine alone, for caudal epidural analgesia in 68 children of 2-6years of age, belonging to ASA class 1and 2, undergoing elective infraumbilical surgery of less than 1hour duration, to be conducted in a tertiary care center in Kerala. The primary outcome will be duration of analgesia. The secondary outcomes will include duration of sedation, emergence time and duration of motor block. |