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Effectiveness of magnesium sulphate in improving spinal anesthesia when given in the subarachnoid space versus when given intravenously in lower limb surgeries.

Efficacy of magnesium sulphate as an adjuvant by intrathecal versus intravenous route with 0.75% hyperbaric ropivacaine to augment quality of spinal anesthesia in lower limb surgeries - a randomized controlled clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/045072
Enrollment
166
Registered
2022-08-30
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Interventions

Intervention1: 50 milligrams of magnesium sulphate with 3ml of 0.75% hyperbaric ropivacaine.: Both the drugs will be given intrathecally. Control Intervention1: Intravenous magnesium sulphate with 3ml

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: All adult male and female patients of age between 18-69 years and belonging to American society of Anaesthesiologists Physical status I & II posted for elective lower limb surgeries. Consenting patients posted for elective lower limb surgeries. Surgeries with a duration less than 2 hours(120 minutes).

Exclusion criteria

Exclusion criteria: Patient refusal. Patients of age less than 18 years and more than 70 years. History of allergy to drugs used in the study like ropivacaine, magnesium sulphate, paracetamol, ondansetron. Lower limb surgeries lasting less than 30 minutes and more than 120 minutes. All contraindications to spinal anesthesia.

Design outcomes

Primary

MeasureTime frame
To assess the quality of subarachnoid block by time taken for onset and duration of sensory and motor component of subarachnoid block by using the cold swab test and modified bromage scale respectively.Timepoint: The time taken for onset of block is assessed at 3 minute intervals for the first 20 minutes after giving spinal anesthesia. Duration of block is assessed at 30 minute intervals intra operatively and post operatively at 30 minute intervals for first 2 hours and then after at 4th, 8th and 12th post operative hours.

Secondary

MeasureTime frame
The duration of analgesic effect of subarachnoid block is assessed by time taken to first dose of rescue analgesia from T0(zero hour), which is defined as the time of arrival in the post anesthetic care unit. Visual analogue score is used to assess the intensity of pain post operatively, every 30 minutes for the first 2 hours of postoperative period and then after at 4th, 8th and 12th postoperative hours. Duration of analgesia is defined as the time duration from completion of surgery to the time patient requested first dose of rescue analgesia(VAS score4). The changes in hemodynamic parameters both intra operatively and postoperatively. To observe the incidence of adverse events like post operative nausea and vomiting, flushing and itching.Timepoint: Intra operatively at 30 minute intervals. Post operatively at 30 minute intervals for first 2 hours and then after at 4th, 8th and 12th post operative hours.

Countries

India

Contacts

Public ContactDr Siva Teja Doddipatla

Kalinga Institute of Medical Sciences(KIMS)

amrita.panda@kims.ac.in9439862335

Outcome results

None listed

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