| CTRI Number |
CTRI/2019/05/019341 [Registered on: 24/05/2019] Trial Registered Prospectively |
| Last Modified On: |
23/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effectiveness and safety of different doses of a drug clonidine when used along with a drug bupivacaine in spinal anesthesia |
|
Scientific Title of Study
|
A prospective randomized controlled trial to compare the efficacy and safety of different doses of clonidine when used as an adjuvant to intrathecal bupivacaine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajwala S Kaushik |
| Designation |
Assistant professor |
| Affiliation |
J J hospital |
| Address |
Department of Anesthesia
GGMC & JJ Hospital
Byculla
Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
|
| Fax |
|
| Email |
olesi_psk@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prajwala S Kaushik |
| Designation |
Assistant professor |
| Affiliation |
J J hospital |
| Address |
Department of Anesthesia
GGMC & JJ Hospital
Byculla
Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
|
| Fax |
|
| Email |
olesi_psk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prajwala S Kaushik |
| Designation |
Assistant professor |
| Affiliation |
J J hospital |
| Address |
Department of Anesthesia
GGMC & JJ Hospital
Byculla
Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
|
| Fax |
|
| Email |
olesi_psk@yahoo.com |
|
|
Source of Monetary or Material Support
|
| JJ hospital
Byculla
Mumbai 400008 |
|
|
Primary Sponsor
|
| Name |
J J hospital |
| Address |
Dept of Anesthesia
GGMC and JJ hospital
Byculla, Mumbai |
| 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 |
| Prajwala |
J J hospital |
Department of Anesthesia,
Byculla
Mumbai
Mumbai
MAHARASHTRA |
9022739514
olesi_psk@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S729||Unspecified fracture of femur, (2) ICD-10 Condition: S929||Unspecified fracture of foot and toe, (3) ICD-10 Condition: S829||Unspecified fracture of lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine 0.5% heavy 2.3 ml with 30mcg clonidine in subarachnoid block |
Bupivacaine 0.5% heavy 2.4 ml with 15mcg clonidine in subarachnoid block |
| Intervention |
Bupivacaine 0.5% heavy 2.5ml without clonidine in Spinal Anesthesia |
Bupivacaine 0.5% heavy with clonidine in Spinal Anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I or II normotensive patients undergoing elective orthopaedic surgery |
|
| ExclusionCriteria |
| Details |
ASA III & above, patients with cardiovascular, renal, liver dysfunction, allergy to clonidine or bupivacaine, short height (<130cm), obese(BMI > 30kg/m2) or with contraindication to spinal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of analgesia/sensory block
Block height
Hemodynamic variations-pulse, MAP
Complications |
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic effects-pulse and MAP
Complications |
1 year |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2019 |
| 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="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
|
Spinal anesthesia has been the technique of choice for lower limb and abdominal surgeries and is preferred over general anesthesia. Many adjuvants have been studied to prolong the duration of action of spinal anesthesia. In our study we would like to study the effects of adding different doses of clonidine as a adjuvant to bupivacaine in subarachnoid block and observe the effects and adverse events |