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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  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal, Karnataka 576104  
 
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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
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.
 
 
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 
 
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.

 
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