| CTRI Number |
CTRI/2021/08/036054 [Registered on: 31/08/2021] Trial Registered Prospectively |
| Last Modified On: |
27/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Of Intrathecal Dexamethasone And Intrathecal Dexmedetomidine To Prevent Shivering. |
|
Scientific Title of Study
|
Comparative Study Between Dexamethasone And Dexmedetomidine As An Adjuvant To Intrathecal Bupivacaine For Prevention Of Perioperative Shivering In Patients Undergoing Traumatic Lower Limb Orthopedic Surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonalika Arora |
| Designation |
Junior Resident |
| Affiliation |
Dr S.N. Medical College Jodhpur |
| Address |
Department Of Anesthesiology And Critical Care Dr Sampurnanand Medical College Jodhpur
Residency Road Shastri Nagar Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9887798178 |
| Fax |
|
| Email |
soniaarora320@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobha Ujwal |
| Designation |
Senior Professor |
| Affiliation |
Dr S.N. Medical College |
| Address |
Orthopedic Operation Theater Mathura Das Mathur Hospital Jodhpur
Residency Road Shastri Nagar Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9461028789 |
| Fax |
|
| Email |
drshobhaujwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonalika Arora |
| Designation |
Junior Resident |
| Affiliation |
Dr S.N. Medical College Jodhpur |
| Address |
Department Of Anesthesiology And Critical Care Dr Sampurnanand Medical College Jodhpur
Residency Road Shastri Nagar Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9887798178 |
| Fax |
|
| Email |
soniaarora320@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr S.N. Medical College Jodhpur 342003 |
|
|
Primary Sponsor
|
| Name |
Dr S N Medical College Jodhpur |
| Address |
Residency Road Shastri Nagar Jodhpur 342003 |
| 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 |
| Sonalika Arora |
Mathura Das Mathur Hospital Jodhpur |
Department Of Anesthesiology And Critical Care Dr Sampurnanand Medical College Jodhpur
Jodhpur
RAJASTHAN |
9887798178
soniaarora320@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ehticas Committee Dr S N Medical College Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison Of 4mg Dexamethasone And 5μg Dexmedetomidine As Adjuvant To Bupivacaine |
Group B receive 2.5ml of hyperbaric bupivacaine 0.5% (12.5mg) +5μg dexmedetomidine. (total volume 3.5ml) |
| Intervention |
Sub Arachnoid Block |
Group A received 2.5ml of hyperbaric bupivacaine 0.5% (12.5mg) +4mg dexamethasone (total volume 3.5ml) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 age 20 to 60 years
2 ASA: I & II
3 Surgery: Traumatic lower limb orthopaedic surgery of duration of maximum 2hours.
|
|
| ExclusionCriteria |
| Details |
1 Patients who refuse to give written informed consent.
2 Patients with infection at the site of injection
3 Spine abnormalities.
4 Patients with allergy to study drug.
5 Patients with cardiac diseases (like heart block, dysarrythmias), renal or other organ system disease which preclude choice of spinal anaesthesia.
6 Patients with head injuries.
7 Pregnant females
8 Any contraindication to spinal anaesthesia like abnormal coagulation profile, sepsis.
9 Emergency surgery
10 Patients with allergy to study drug |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the incidence of shivering in patients with traumatic lower limb orthopaedic surgery. |
every 4 min for first 20 min, then every 10min till end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset and duration of Sensory block.
Onset and duration of motor block.
Ramsey Sedation score
VAS Score
Time of first rescue analgesia.
|
onset of sensory block will be observed 2min for first 10 min after SAB and every 5min
sedation recorded every 6hourly till 24 hours
pain level on the line between the two endpoints after 6 hr,12hr 18hr,24hr of the surgery.
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/09/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Through This Study We Want To Compare The Efficacy Of Intrathecal Dexamethasone And Dexmedetomidine As An Adjuvant To Intrathecal Bupivacaine For Prevention Of Perioperative Shivering In Patients Undergoing Traumatic Lower Limb Orthopedic Surgeries |