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CTRI Number  CTRI/2019/08/020954 [Registered on: 28/08/2019] Trial Registered Prospectively
Last Modified On: 27/08/2019
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 clinical study to compare administration of drug named Dexmedetomidine in two different doses as an additive to Local Anaesthetic Ropivacaine in children undergoining surgeries below umbilicus  
Scientific Title of Study   Comparison of Two Different Doses of Dexmedetomidine as an Adjuvant to Ropivacaine in Caudal Epidural Analgesia for Paediatric Infraumbilical Surgeries: A Randomised Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BELINDA CHERIAN 
Designation  POST GRADUATE 
Affiliation  SRM MEDICAL COLLEGE AND RESEARCH CENTER 
Address  Department of Anaesthesiology Srm Medical College Hospital Potheri Kancheepuram TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  8139825608  
Fax    
Email  belindacherian93@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rajagopalan Venkatraman 
Designation  Professor 
Affiliation  SRM MEDICAL COLLEGE AND RESEARCH CENTER 
Address  Department of Anaesthesiology Srm Medical College Hospital Potheri Kattankulathur Kancheepuram TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  09894581455  
Fax    
Email  drvenkat94@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajagopalan Venkatraman 
Designation  Professor 
Affiliation  SRM MEDICAL COLLEGE AND RESEARCH CENTER 
Address  Department of Anaesthesiology Srm Medical College Hospital Potheri Kattankulathur Kancheepuram TAMIL NADU 603203 India

Coimbatore
TAMIL NADU
603203
India 
Phone  09894581455  
Fax    
Email  drvenkat94@gmail.com  
 
Source of Monetary or Material Support  
SRM Institute of Science and Technology, Srm nagar, Potheri, kancheepuram District, Tamilnadu - 603203. 
 
Primary Sponsor  
Name  SRM MEDICAL COLLEGE HOSPITAL 
Address  Room no 1, B Block, Department of Anaesthesiology Potheri Kattankulathur 603203 Kancheepuram TAMIL NADU 
Type of Sponsor  Research institution and hospital 
 
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 
BELINDA CHERIAN  SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER  Room no 101, B block,Department of Anaesthesiology Srm Medical College Hospital Potheri Kattankulathur Kancheepuram TAMIL NADU
Kancheepuram
TAMIL NADU 
8139825608

belindacherian93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CAUDAL ANALGESIA  Anesthesia produced by injection of a local anesthetic into the caudal canal, the sacral portion of the spinal canal.  
Comparator Agent  dexmedetomidine  Caudal block with Dexmedetomidine will provide consistent, sustained and prolonged duration of analgesia with favorable intraoperative conditions in pediatric age group 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  ASA grade I and II
Patients weighing between 10-30 kg
Surgeries lasting 30 minutes to 2 hours 
 
ExclusionCriteria 
Details  Parents refusal
ASA III&IV
Duration of surgery more than 2 hours
Neuromuscular and spine disorders.
Cardiovascular disorder
Patients on anticoagulants
Infection over the injection site
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of postoperative analgesia
 
Duration of post-operative analgesia is defined as the time interval between the administration of caudal block and the first requirement of rescue analgesia postoperatively.
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the: 1.Sedation score 2.Hemodynamics 3.Incidence of side effects like bradycardia and hypotension.
 
24 hours after the caudal block 
 
Target Sample Size   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)   09/09/2019 
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)?  

Brief Summary  
All Parents will be explained about the anaesthetic technique and written informed consent will be taken during pre-anesthetic visit.Patients will be randomly allocated into two groups by computer generated random envelope method.First anesthesiologist will prepare the solution and second anesthesiologist will administer the block and monitor the patient.Nil per oral (prior to the procedure) will be ensured in all the patients as per fasting guidelines.Patient will be pre-medicated with Syrup Triclofos 50 mg/kg 2 hours prior to surgery.Patient will be shifted into the operation theatre and the monitors ECG, Pulse oximeter and Blood pressure cuff will be attached. Baseline values will be recorded.All the surgical procedures will be done under general anaesthesia.Injection Glycopyrolate 0.01mg/kg intravenous will be given.Injection fentanyl 2mcg/kg intravenous will be used for analgesia.Patients will be pre-oxygenated with 100% oxygen for 3 minutes via face mask.All patients will be induced with Injection Propofol 2mg/kg intravenous.Appropriate size Classic Laryngeal Mask Airway will be inserted.Anaesthesia will be maintained with oxygen and nitrousoxide in 1:1 ratio and Sevoflurane as inhalational agent with the patient breathing spontaneously via Jackson-Rees breathing system.Caudal block will be performed under aseptic conditions with the child in a left lateral position.Volume of drug will be defined by Modified Armitage formula.(0.25ml/kg for sacral surgery,0.5ml/kg for lumbar surgery,0.75ml/kg for lower abdomen surgery) Patients in Groups A (n=30), will receive injection Ropivacaine 0.2%+ injection Dexmedetomidine 1µgm/kg . Patients in Groups B (n=30) will receive injection Ropivacaine 0.2%+ injection Dexmedetomidine 2µgm/kg.The child will be turned to supine position immediately.At the end of the surgery, Classic Laryngeal Mask Airway will be removed in the deeper plane of anaesthesia. Patient will be observed for pulse rate, B.P. SpO2 and sedation in recovery area & will be shifted to post-operative ward when the sedation score =3.An intra- or postoperative decrease of MAP or HR more than 30% from baseline values will be defined as hypotension or bradycardia respectively.Hypotension will be treated with a rapid infusion of fluids .If it is unresponsive to fluid, hypotension can be treated by injection Ephedrine. Bradycardia will be treated with injection atropine, as appropriate.If the patient complains of pain within 2 hours of surgery, it will be considered as failed caudal block, which will be excluded from the study. Sedation will be assessed by the Ramsay Sedation Score.(1= anxious and agitated, 2=cooperative, calm. 3=responsive to commands 4= brisk response to glabellar tap, 5 = light response to glabellar tap, 6 =unresponsive).The rescue analgesia will be given in the form of Intravenous Paracetamol 15mg/kg if Wong-baker pain score is more than 4.Duration of post-operative analgesia is defined as the time interval between the administration of caudal block and the first requirement of rescue analgesia postoperatively. All patients will be observed for any side-effects like nausea, vomiting, bradycardia and hypotension.
 
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