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T spinal anesthesia addition of new drug magnesium to routine local anesthetics

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020288
Enrollment
80
Registered
2019-07-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Spinal Anaesthesia with Ropivacaine and Magnesium Sulphate: Spinal Anaesthesia with Ropivacaine with sterile water Intervention2: Administration of Ropivacaine 0.5% 2ml with dextrose 25

Sponsors

Mahatma Gandhi Medical Collage and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1 and 2 patients, Patients posted for all infraumblical surgeries of approximatly 2 hours duration, Minimal expected bloods loss surgeries.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Total duration of sensory loss.Timepoint: 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

MeasureTime frame
a)Total duration of motors blockade, b)Quality of post op analgesia, c)Hemodynamic parameters, Associated complications.Timepoint: 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.

Countries

India

Contacts

Public ContactAntony John Charles S

Mahatma Gandhi Medical Collage

anjocharlie@gmail.com9600931102

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026