| CTRI Number |
CTRI/2022/01/039100 [Registered on: 03/01/2022] Trial Registered Prospectively |
| Last Modified On: |
29/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of effectiveness of dexmedetomidine, when added to bupivacaine in spinal anaesthesia for lower limb surgery |
|
Scientific Title of Study
|
Effect of intrathecal Dexmedetomidine as an adjuvant to hyperbaric bupivacaine in orthopaedic lower limb surgery: An Intervention Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neelam Golia |
| Designation |
3rd Year Resident in Anaesthesiology |
| Affiliation |
Dr S.N. Medical College, Jodhpur |
| Address |
Department of Anaesthesiology,
Dr S.N.Medical College and attached hospitals,Jodhpur
Rajasthan
342003
India
Jodhpur
RAJASTHAN
342003
India |
| Phone |
8764346240 |
| Fax |
|
| Email |
drneelam016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Fateh Singh Bhati |
| Designation |
Senior Professor in Department of Anaesthesiology |
| Affiliation |
Dr S.N.Medical College,Jodhpur |
| Address |
Department of Anaesthesiology,
Mahatma Gandhi hospital,
Dr S.N.Medical College,Jodhpur
Rajasthan
342003
India
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9414127176 |
| Fax |
|
| Email |
fatehbhati68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fateh Singh Bhati |
| Designation |
Senior Professor in Department of Anaesthesiology |
| Affiliation |
Dr S.N.Medical College,Jodhpur |
| Address |
Department of Anaesthesiology,
Mahatma Gandhi Hospital,
Dr S.N.Medical College,
Jodhpur
Rajasthan
342003
India
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9414127176 |
| Fax |
|
| Email |
fatehbhati68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,
Dr S.N.Medical College,Jodhpur 342003,Rajasthan,India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Dr S.N.Medical College,Jodhpur 342003,Rajasthan,India |
| 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 |
| Dr Neelam Golia |
Department of Anaesthesiology |
Dr S.N. Medical College,Jodhpur
342003,Rajasthan
India
Jodhpur
RAJASTHAN |
8764346240
drneelam016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Dr S.N. Medical College, Jodhpur 342003,Rajasthan,India |
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 |
control |
2.5ml bupivacaine 0.5% heavy with 0.5ml normal saline,single dose |
| Intervention |
dexmedetomidine |
5 mcg added to 2.5ml bupivacaine 0.5% heavy,single dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 to 65 years
2.Both genders
3.ASA grade I and II
|
|
| ExclusionCriteria |
| Details |
1.History of spine surgery, hepatic failure, neuromuscular disorders 2.chronic history of headache, backache and infection in back 3.Any absolute or relative contraindication to study drug
4.Uncooperative patients 5.Coagulopathy 6.Patient with history of cardiac or respiratory diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| motor block regression in bromage score,sensory block regression by pin prick sensation |
6 to 8 hours after intrathecal injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset of Sensory and motor block, Hemodynamic alterations,
Numeric Rating Scale 6 hours after surgery. |
0 min,5 min,10 min,15 min,
20 min,25 min,30 min,45 min,
60 min,75 min,90 min,105 min,
120 min,240 min,360 min. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/01/2022 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
Dexmedetomidine is an alpha-2 adrenergic receptor agonist recently introduced in indian market. It has been used as an adjunct to spinal and general anaesthesia and for sedation in intensive care unit. The aim of present study is to evaluate the efficacy of dexmedetomidine as an adjunct to bupivacaine in subarachnoid block.
Study will be carried out in 50 ASA physical status I and II, aged 18 to 65 years going to undergo lower limb orthopaedic surgery. Patients will be randomly allocated into 2 groups, each of 25 by computer generated random number table. 1st group will be given bupivacaine and 2nd group will be given bupivacaine + dexmedetomidine in subarachnoid space. Patients will be assessed for onset and duration of sensory and motor block produced by both groups. Analgesia, hemodynamic variables and complications will be recorded intraoperatively. Patients will be observed for 6 hours postoperatively. Data will be expressed as mean and standard deviation or numbers and percentages as applicable. Comparison between two groups will be done using unpaired t test for quantitative data and chi square test for qualitative data. p value <0.05 will be considered significant. |