| CTRI Number |
CTRI/2017/12/010744 [Registered on: 04/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
04/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Observation of effect of dexmedetomidine when given intravenously to the pediatric patients undergoing levobupivacaine spinal anaesthesia. |
|
Scientific Title of Study
|
Effect of i.v.dexmedetomidine on levobupivacaine spinal anaesthesia in pediatric patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhav Sonavia |
| Designation |
Tutor |
| Affiliation |
Goverment medical college |
| Address |
Anaesthesia deparatment,Goverment medical college,Majura gate,Surat.
Anaesthesia deparatment,Goverment medical college,Majura gate,Surat.
Surat
GUJARAT
395001
India |
| Phone |
9099934244 |
| Fax |
|
| Email |
dr.vaibhavsonavia@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neeta Kawishwar |
| Designation |
Head of Anaesthesia department |
| Affiliation |
goverment medical college |
| Address |
Anaesthesia Department,Goverment Medical College,Majura Gate,Surat.
Surat
GUJARAT
395001
India |
| Phone |
9099934244 |
| Fax |
|
| Email |
Abhishek6777777@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
vaibhav sonavia |
| Designation |
Tutor |
| Affiliation |
Goverment medical college,Majura gate,Surat |
| Address |
Anaesthesia department,Goverment medical college,Majura gate,Surat
Anaesthesia department,Goverment medical college,Majura gate,Surat
Surat
GUJARAT
395001
India |
| Phone |
9099934244 |
| Fax |
|
| Email |
dr.vaibhavsonavia@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia |
| Address |
Anaesthesia department,Government medical college,Majura gate,Surat. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| drvaibhavsonavia |
Government medical college |
Anaesthesia deparment,Government medical college,Majura gate,surat
Surat
GUJARAT |
9099934244
dr.vaibhavsonavia@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
good health., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine |
effect of i.v. dexmedetomidine either prolong or not spinal levobupivacaine effect..and what are other others effects of i.v. dexmedetomidine. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) class-1 and class-2 patients
2) lower abdominal surgery
3) 2 year to 12 year age |
|
| ExclusionCriteria |
| Details |
1) patients refusal.
2) contraindication for spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intravenous dexmedetomidine prolong the effect of bupivacaine spinal anaesthesia |
end of clinical trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
provide haemodynamic stability.
provide good intraoperative sedation and pain free period during operation and postoperative period |
end of clinical trial |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/04/2015 |
| Date of Study Completion (India) |
15/11/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1) Spinal anaesthesia in pediatric patient is reliable. 2) Levobupivacaine 0.5% isobaric in recommended dose can produce effective sensory and motor block. 3)When data of this study was compared with other study it can be inferred that dexmedetomidine 0.5% microgram/kg given before spinal anaesthesia can prolong the duration of sensory effect. 4)Sedation for procedure as well as during surgery is required in more number of smaller children than older children. 5)Dexmedetomidine 0.5%microgram/kg can be safely used in children between 2-12 year of age. 6)Spinal anaesthesia in pediatric patients is not associated with much perioperative complications. |