| CTRI Number |
CTRI/2024/11/076943 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
The effect of clonidine added to local anaesthetic levobupivacaine for pain relief in caudal block to reduce the chance of agitation during post-operative recovery in children undergoing infra umbilical and lower limb surgery with sevoflurane anaesthesia |
Scientific Title of Study
Modification(s)
|
Effect of Caudal additive Clonidine to Levobupivacaine in Reducing Incidence of Emergence Agitation in Children Undergoing Infra-Umbilical Surgeries with Sevoflurane Anaesthesia – a prospective Observational 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 Shabnam Nazar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Anaesthesiology
Kasturba Medical College and Hospital
Madhav Nagar, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9207586922 |
| Fax |
|
| Email |
dr.shabnamnazar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Malavika |
| Designation |
Head of Department and guide |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Anaesthesiology
Kasturba Medical College and Hospital
Madhav Nagar, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9844241620 |
| Fax |
|
| Email |
malavika.muralidhar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Priya G D Mello |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Anaesthesiology
Kasturba Medical College and Hospital
Madhav Nagar, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9480014695 |
| Fax |
|
| Email |
priya.demello@manipal.edu |
|
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Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal, Karnataka 576104
|
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Primary Sponsor
|
| Name |
Kasturba Medical College and Hospital |
| Address |
Manipal Academy of Higher Education
Madhav Nagar, Manipal
Karnataka 576104 |
| Type of Sponsor |
Private medical college |
|
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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 Shabnam Nazar |
Kasturba Hospital, Manipal |
Department of Anaesthesiology
Madhav Nagar, Manipal Udupi KARNATAKA |
9207586922
dr.shabnamnazar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee -2 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Paediatric patients undergoing infra umbilical surgeries under general anaesthesia without endotracheal intubation
2.Age 3 - 10 years
3.American Society of Anaesthesiologists (ASA) status I and II.
|
|
| ExclusionCriteria |
| Details |
1.Guardian refusal to consent.
2.Patients with developmental delay, intellectual disability, behavioural disorders, cardiac diseases.
3.Contraindication for caudal block (infection at site of block, bleeding diathesis, pre-existing spinal disease, abnormalities of sacrum)
4.Pre-operative agitation (difficult to separate from parents despite midazolam premedication)
5.Potential difficult airway
6.Additional iv analgesic requirement intra operatively after caudal administration.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of emergence agitation |
PAED score at immediate post extubation, 5 min, 10min, 15 min, 30 min, 45 min and 60 min post extubation |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.Time to emergence
2.Post operative pain relief
3.Sedation
4. Side ffects |
PAED score at immediate post extubation, 5 min, 10min, 15 min, 30 min, 45 min & 60 min after extubation |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60" Sample Size from India="60"
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)
|
27/11/2024 |
| 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="11" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 aims to compare the effects of caudal additives clonidine and fentanyl to levobupivacaine in reducing emergence agitation in children undergoing infra-umbilical surgeries with sevoflurane anaesthesia. Caudal block is one of the most reliable and safest techniques for paediatric lower abdominal regional anaesthesia and analgesia and has been found to protect against emergence agitation. Conducted at Kasturba Medical College, the prospective observational study will enroll 120 paediatric patients aged 3 to 10 years undergoing general anaesthesia with sevoflurane and caudal block for infraumbilical surgeries, excluding those with neurological or behavioural disorders, difficult airway or contraindications for caudal blocks. The primary objective is to assess the efficacy of these additives in preventing emergence agitation, a short lived, common and distressing phenomenon during post operative recover period following general anaesthesia. Secondary outcomes will assess time to emergence, duration of postoperative pain relief, sedation levels, and any side effects associated with the additives. Ethical approval and informed consent will be obtained prior to participation. A pre-anaesthetic evaluation will be conducted, and standard fasting protocols will be followed. Anaesthesia will be induced with IV propofol, paralysed with atracurium and anaesthesia maintained with nitrous oxide and sevoflurane, along with a caudal blockade using levobupivacaine combined with either clonidine or fentanyl as per the discretion of concerned consultant anaesthesiologist. Vital signs will be continuously monitored during the procedure. Post-surgery, neuromuscular reversal will occur, and patient extubated. Emergence time will be measured. In the Post Anaesthesia Care Unit, children will be evaluated for emergence agitation, pain and sedation using specific scoring systems. |