| CTRI Number |
CTRI/2019/10/021662 [Registered on: 16/10/2019] Trial Registered Prospectively |
| Last Modified On: |
15/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effects of i.v.Dexmedetomidine on Spinal Anaesthesia in Lower Limb Orthopaedic Surgeries. |
|
Scientific Title of Study
|
Effects of IV Dexmedetomidine on Spinal Anaesthesia in Lower Limb Orthopedic Surgeries.
Randomized double blinded placebo controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MALLIDI CHANDRASEKHARA REDDY |
| Designation |
POST GRADUATE 1st YEAR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES,BHUBANESWAR |
| Address |
KIMS,Campus- 5 STAFF QUARTERS,ROOM NO.A 05,KIIT UNIVERSITY,BHUBANESWAR
Khordha
ORISSA
751024
India |
| Phone |
6309547889 |
| Fax |
|
| Email |
healing.chandu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drakshya kumar parida |
| Designation |
professor dept of anaesthesiology |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES,BHUBANESWAR |
| Address |
KIMS,CAMPUS 5 STAFF QUARTERS,b2,KIIT UNIVERSITY,BHUBANESWAR
CAMPUS 5 STAFF QUARTERS,b2,KIIT UNIVERSITY,BHUBANESWARRSITY,BHUBANESWAR
Khordha
ORISSA
751024
India |
| Phone |
9861007297 |
| Fax |
|
| Email |
drakparida@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MALLIDI CHANDRASEKHARA REDDY |
| Designation |
POST GRADUATE 1st YEAR |
| Affiliation |
Department of anesthesiology,KALINGA INSTITUTE OF MEDICAL SCIENCES,BHUBANESWAR |
| Address |
KIMS,campus-5 STAFF QUARTERS,ROOM NO.A 05,KIIT UNIVERSITY,BHUBANESWAR
KIMS,Campus-5 STAFF QUARTERS,ROOM NO.A 05,KIIT UNIVERSITY,BHUBANESWAR
Khordha
ORISSA
751024
India |
| Phone |
6309547889 |
| Fax |
|
| Email |
healing.chandu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Mallidi.chandrasekhara reddy |
|
|
Primary Sponsor
|
| Name |
MALLIDI CHANDRASEKHARA REDDY |
| Address |
Deparment of anesthesia
kalinga institute of medical sciences .bhubaneswar |
| 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 |
| mallidi chandrasekhara reddy |
kalinga Institute of Medical Sciences |
Department of anesthesiology,KIMS,Patia, Bhubaneswar
Khordha
ORISSA |
6309547889
healing.chandu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,KALINGA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IV DEXMEDETOMIDINE |
iv dexmedetomidine infusion after spinal anesthesia |
| Comparator Agent |
IV NORMAL SALINE |
iv normal saline infusion after spinal anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Asa status 1&2
Patients undergoing lower limb orthopedic surgery
|
|
| ExclusionCriteria |
| Details |
PATIENTS WITH SINUS BRADYCARDIA
PATIENTS WITH ARRYTHMIA
ANY CONTRAINDICATIONS FOR SPINAL ANAESTHESIA
HISTORY OF DRUG HYPERSENSITIVITY
PATIENTS REFUSAL |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration for conducting the spinal block
Quality and duration of spinal block
Post operative pain & analgesia requirement
SPINAL BLOCK.
POST OPERATIVE PAIN AND ANALGESIA REQUIREMENT. |
Level of sensory block and quality of motor block at 5 min of spinal anaesthesia till 15 minutes.
 Time for two segment regression after completion of surgical procedure.
 Level of sedation (Ramsay sedation score) at 15minutes interval till the patient discharge from post anaesthesia care unit or fully alert.
 Post operative pain ( VAS score), time to requirement of 1st rescue analgesia, and total rescue doses in first 24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Level of sedation
Hemodynamic changes
|
Pulse rate, blood pressure, SpO2 & ECG will be recorded at 5 minutes interval
 Level of sedation (Ramsay sedation score) at 15minutes interval till the patient discharge from post anaesthesia care unit or fully alert. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/10/2019 |
| 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="3"
Months="0"
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
|
—Orthopaedic procedures of lower limbs are best done
under spinal anaesthesia but the major problem is positioning the patient for
spinal block
—Due to the injury and pain, longer time is taken for
positioning and to achieve a successful Dural tap.
—The discomfort and distress of positioning requires
prior administration of strong IV narcotics, which have the disadvantage of
over sedation, respiratory depression & poor co-operation
—Dexmedetomidine is a very potent a2 agonist which causes
dose dependent sedation, anxiolysis ,some analgesia, blunting stress response
and also with opioid sparing effect
|