| CTRI Number |
CTRI/2019/07/020288 [Registered on: 22/07/2019] Trial Registered Prospectively |
| Last Modified On: |
03/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
T
spinal anesthesia addition of new drug magnesium to routine local anesthetics |
|
Scientific Title of Study
|
Comparison of Intrathecal Hyperbaric Ropivacaine 0.5% with and without 75 mg of Magnesium Sulphate as an adjuvant for Infraumblical Surgeries-A Double Blind Randomised Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srinidhi Srikanth |
| Designation |
Post Graduate |
| Affiliation |
Mahatma Gandhi Medical Collage |
| Address |
Department of Anesthesiology
Mahatma Gandhi Medical Collage and Research Institute,
Pillayarkuppam
Puducherry.
Pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8825424934 |
| Fax |
|
| Email |
srinidhisrikanth12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Antony John Charles S |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical Collage |
| Address |
Department of Anaesthesiology
Mahatma Gandhi Medical Collage and Research Institute,
Pillayarkuppam
Puducherry.
Pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9600931102 |
| Fax |
|
| Email |
anjocharlie@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Antony John Charles S |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical Collage |
| Address |
Department of Anaesthesiology
Mahatma Gandhi Medical Collage and Research Institute,
Pillayarkuppam
Puducherry.
Pillayarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9600931102 |
| Fax |
|
| Email |
anjocharlie@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute
Pillayarkuppam
Puducherry |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical Collage and Research Institute |
| Address |
Department of Anesthesiology
Mahatma Gandhi Medical Collage and Research Institute
Pilliyarkuppam
Puducherry |
| Type of Sponsor |
Private 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 |
| Srinidhi Srikanth |
Mahatma Gandhi Medical College and Research institute |
Pilliayarkuppam
pondicherry-Cuddalore
ECR road
Puducherry- 607402
Pondicherry
PONDICHERRY |
8825424934
srinidhisrikanth12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Administration of Ropivacaine 0.5% 2ml with dextrose 25% 1ml with Magnesium sulphate 75 mg |
Administration of Ropivacaine 0.5% 2ml with dextrose 25% 1ml with Magnesium sulphate 75 mg in intrathecal space and to asses the haemodynamics, sensory level and duration of block action. |
| Comparator Agent |
Administration of Ropivacaine 0.5% 2ml with dextrose 25% 1ml with sterile water 0.75 ml |
Administration of Ropivacaine 0.5% 2ml with dextrose 25% 1ml with sterile water 0.75 ml and to asses the haemodynamics, sensory level and duration of block action. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients,
Patients posted for all infraumblical surgeries of approximatly 2 hours duration,
Minimal expected bloods loss surgeries. |
|
| ExclusionCriteria |
| Details |
Patient unwilling to participate,
Pregnant and breast feeding mothers,
Patient with coagulation or bleeding disorders,
Local spinal site infection,
Spinal abnormalities or spinal instrumentation procedures,
BMI>30,
Patient posted for surgeries for more than 2 hours duration,
Patients with unstable hemodynamics. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total duration of sensory loss. |
2 mins for first 10 mins,there after every 5 mins till fixation level is acheived.Every 15 mins till regression to T10 level thereafter every 30 mins till complete regression to S2 level. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)Total duration of motors blockade,
b)Quality of post op analgesia,
c)Hemodynamic parameters,
Associated complications. |
a)Bromage scale from grade 0 to 3
b)At 3 hrs,6 hrs,9 hrs,18 hrs and 24 hrs.
c)for 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/08/2019 |
| Date of Study Completion (India) |
02/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Spinal anesthesia is a preferable anesthesia technique for various day-care orthopedic, obstetric and lower abdominal surgeries.Hyperbaric Lignocaine was commonly used for ambulatory procedures due to its short duration of action, but numerous reports of Transient Radicular Irritation (TRI) was reported after its use. Ropivacaine, (Approved by European Union for intrathecal use in 2004) has been demonstrated to provide safe and reliable spinal anesthesia of intermediate duration, with relatively shorter duration of motor blockade compared to Bupivacaine; encouraging earlier mobilization in patients.Due to difficulty in maintaining pharmacological stability of hyperbaric Ropivacaine, currently only isobaric solution are available. But Ropivacaine, made hyperbaric by adding desired quantity of Dextrose, has been compared with isobaric solution for spinal anesthesia, and a predictable block with better cephalad spread and a quicker sensory and motor regression with the former has been proven.Opioid adjutants have been used with intrathecal Ropivacaine for extending duration of block and their associated side effects like nausea, vomiting, bladder retention, purities, paralytic ileus and respiratory depression have been noted.Intrathecal Magnesium sulphate, has been used in humans since 1906.10 It is a non competitive antagonist of N-methyl-D-aspartate (NMDA) glutamate and inositol triphosphate-gated calcium channels, and it blocks the spinally mediated facilitatory component evoked by repetitive C-fibre stimulation (activity dependant increase in excitability of spinal neurons). This can prevent and abolish central sensitisation.Ropivacaine is emerging as a local anesthetic of choice to provide spinal anesthesia for day care surgeries of shorter duration and Magnesium sulphate is a non opioid adjuvant devoid of various undesirable effect; and hence, we decided to conduct this randomised trial to demonstrate the effects of Magnesium Sulphate as an adjuvant to intrathecal hyperbaric Ropivacainefor infra umbilical surgeries. |