| 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
|
|
|
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 |
|
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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: 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 |
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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. |