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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03725228

Enrollment

Registered

2018-10-30

Start date

2018-11-07

Completion date

2019-04-01

Last updated

2020-02-27

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

Conditions

Anesthesia, Pain

Brief summary

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

Detailed 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.

Interventions

DRUGMagnesium Sulfate

Magnesium Sulfate 15mg/kg/h

DRUGLidocaine

Lidocaine 1,5mg/kg/h

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
Sensitive block duration	9 hours	Thermal and pinprick level lowering to S2

Secondary

Measure	Time frame	Description
Motor block duration	9 hours	Time to Bromage return to baseline
Two levels regression	9 hours	Time from maximal thermal (cold) sensitive block level to lower two levels
Pain at postanesthesia care unit	1-3 hours	Maximum pain (0-10 verbal scale) during PACU

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026