| CTRI Number |
CTRI/2018/03/012819 [Registered on: 23/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
20/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Unilateral Spinal Anaesthesia using very low drugs and administering drug very slowly. |
|
Scientific Title of Study
|
Assessment of unilateral spinal anaesthesia with 6mg of 0.5% (Hyperbaric) bupivacaine and 90mcg of buprenorphine using low dose- slow injection technique: A prospective study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Singh |
| Designation |
Junior Resident |
| Affiliation |
M.S.Ramaiah Medical College |
| Address |
Department of Anaesthesiology
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
drrahulsingh@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Leena H Parate |
| Designation |
Associate Professor |
| Affiliation |
M.S.Ramaiah Medical College |
| Address |
Department of Anaesthesiology
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
dr_leenag@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Leena H Parate |
| Designation |
Junior Resident |
| Affiliation |
M.S.Ramaiah Medical College |
| Address |
Department of Anaesthesiology
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
dr_leenag@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Investigator Dr Rahul Singh,Junior Resident
Dr Leena H parate,Associate Professor
Dr Ashwini Turai,Senior Resident
Department of Anaesthesiology,M.S.Ramaiah Medical college,Bangalore,Karnataka |
|
|
Primary Sponsor
|
| Name |
Leena H Parate |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, M.S.RAMAIAH MEDICAL COLLEGE & HOSPITALS,BANGALORE |
| Type of Sponsor |
Other [Self funding by investigators] |
|
|
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 Rahul Singh |
M.S.Ramaiah Hospital |
Department of Anaesthesiology
Bangalore
KARNATAKA |
9953333899
drrahulsingh@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M.S.RAMAIAH MEDICAL COLLEGE AND HOSPITALS ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
American Society of Anaesthesiology physical status Grade 1 and 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dependent Lower limb |
Dependent lower limb will be used to assess successful unilateral spinal anaesthesia after 20 mins of spinal anaesthesia with 6mg of 0.5% Bupivacaine and 90mcg of Buprenorphine in all the patients. |
| Comparator Agent |
Non Dependent lower limb |
Non Dependent lower limb will be used to assess successful unilateral spinal anaesthesia after 20 mins of spinal anaesthesia with 6mg of 0.5% Bupivacaine and 90mcg of Buprenorphine in all the patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1,2
Lower limb surgeries |
|
| ExclusionCriteria |
| Details |
Patients with Autonomic neuropathy
Patients with urinary catheter in situ
Patients with Vascular pathology
Patient on Anticoagulant
Patients with Scoliosis
Patients with history of Spinal surgeries
Pregnancy
Severe obese patient (BMI>35Kg/m2)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of Unilateral spinal anaesthesia with 6mg of 0.5% (Hyperbaric) bupivacaine and 90mcg of buprenorphin.
|
20 minutes after spinal anaesthesia
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor fluctuation in cardiovascular parameters (Blood Pressure, Heart Rate) before and after block, Monitor post-operative micturition time, Notice episode of post-operative nausea and vomiting, Requirement of Atropine and ephedrine intra-operatively.
|
To monitor cardiovascular parameters after 20 mins of spinal anaesthesia,
Monitoring 1st episode of micturition time, Monitoring first episodes of nausea and vomiting post operatively. |
|
|
Target Sample Size
|
Total Sample Size="79"
Sample Size from India="79"
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)
|
01/11/2016 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective study to assess | This is a prospective study to assess Unilateral spinal anaesthesia with 6mg of 0.5% (Hyperbaric) bupivacaine and 90mcg of buprenorphine using low dose- slow injection technique in ASA Class 1,2 adults aged 18 years to 65 years undergoing unilateral lower limb surgeries. The primary outcome is assessment of successful unilateral spinal anaesthesia with 1.2 ml (6mg) of 0.5% (Hyperbaric) Bupivacaine and 90 mcg Buprenorphine using low dose- slow flow technique. The secondary outcome is to monitor fluctuation in cardiovascular parameters (Blood Pressure, Heart Rate) before and after block,To monitor post-operative micturition time,To notice episode of post-operative nausea and vomiting,Requirement of Atropine and ephedrine intra-operatively. | |