Efficacy and safety of two different doses of magnesium sulphate as adjuvant in spinal anaesthesia

Efficacy of two different doses of magnesium sulphate as adjuvant to 0.5percent hyperbaric bupivacaine in spinal anaesthesia for lower limb surgeries- A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094076

Enrollment

Registered

2025-09-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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: Addition of magnesium sulphate as adjuvant to 0.5 percent hyperbaric bupivacaine in spinal anaesthesia for lower limb surgeries: Group A: will receive 15mg(3ml) of 0.5 percent hyperbari

Eligibility

Inclusion criteria

Inclusion criteria: 1)ASA physical status 1 or 2 2)Undergoing elective lower limb surgery under spinal anaesthesia 3)Height 140 to 180cms 4)Weight 40 to 80kgs

Exclusion criteria

Exclusion criteria: 1)Known allergy to study drugs 2)Contraindications to spinal anaesthesia 3)Significant cardiovascular/renal/hepatic/neuromuscular disorders 4)Psychological disorder

Design outcomes

Primary

Measure	Time frame
Time of requirement of first dose of rescue analgesia(min)Timepoint: upto 12 hrs	—

Secondary

Measure	Time frame
Time of onset of sensory block(min)Timepoint: ;Time of onset of motor block(min)Timepoint: ;Duration of sensory block(min)Timepoint: ;Duration of motor block(min)Timepoint: ;Hemodynamic changes- HR, SBP, DBP, SpO2 every 5 minutes for first 30 minutes and then every 15 minutes till the end of surgeryTimepoint: ;Post operative VAS score at 1,2,4,6,12 hoursTimepoint: 1,2,4,6,12hours;Incidence of side effects such as post operative nausea and vomiting(PONV), shivering upto 24hoursTimepoint:	—

Measure

Time frame

Time of onset of sensory block(min)Timepoint: ;Time of onset of motor block(min)Timepoint: ;Duration of sensory block(min)Timepoint: ;Duration of motor block(min)Timepoint: ;Hemodynamic changes- HR, SBP, DBP, SpO2 every 5 minutes for first 30 minutes and then every 15 minutes till the end of surgeryTimepoint: ;Post operative VAS score at 1,2,4,6,12 hoursTimepoint: 1,2,4,6,12hours;Incidence of side effects such as post operative nausea and vomiting(PONV), shivering upto 24hoursTimepoint:

—

Countries

India

Contacts

Public ContactDr Sapna Das

Kalinga Institute of Medical Sciences

amitpdear@gmail.com9437191002

Outcome results

None listed

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