Lidocaine Compared to Magnesium Sulfate to Prolong Spinal Anesthesia: Non-inferiority Randomized Clinical Trial

Brasilia University Hospital

Status and phase: Completed; Phase 4

Conditions: Pain; Anesthesia

Treatments: Drug: Lidocaine; Drug: Magnesium Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT03725228

tccRenato2018

Details and patient eligibility

About

This study evaluates the addition of continuous infusion of lidocaine or continuous infusion of magnesium sufate in the duration of spinal anesthesia.

Full description

Both lidocaine and magnesium sulfate have been shown to prolong spinal anesthesia.

The number of studies using magnesium sulfate to improve spinal anesthesia is greater than the number of studies using lidocaine, and methodology varies significantly between studies.

Adverse effects of lidocaine are different from magnesium sulfate's. Lidocaine has a wider therapeutic interval with fewer side effects, including: Drowsiness, Feeling Anxious, Feeling Cold, Nervous, Numbness And Tingling, Signs And Symptoms At Injection Site, Twitching.

Magnesium sulfate's side effects include: heart disturbances, breathing difficulties, poor reflexes, confusion, weakness, flushing (warmth, redness, or tingly feeling), sweating, lowered blood pressure, feeling like you might pass out, anxiety, cold feeling, extreme drowsiness, muscle tightness or contraction, or headache.

Enrollment: 44 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Will receive spinal anesthesia for TURP por Histerectomy

Exclusion criteria

• Protocol violation;
• Severe adverse events;
• Change to general anesthesia or addition of epidural anesthesia;
• Complete or partial spinal block failure;
• Mental status alteration (agitation, confusion, loss of conciousness).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Magnesium Sulfate

Active Comparator group

Description:

Continuous intravenous infusion of 15mg/kg/h of magnesium sulfate, starting just after spinal anesthesia infusion until the end of surgery

Treatment:

Drug: Magnesium Sulfate

Lidocaine

Experimental group

Description:

Continuous intravenous infusion of 1.5mg/kg/h of lidocaine, starting just after spinal anesthesia infusion until the end of surgery

Treatment:

Drug: Lidocaine