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Completed

NCT Number: NCT03725228

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

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

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Key information

Conditions

Anesthesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitário de Brasilia

Brasília, Federal District, 70000000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Magnesium sulfate

Drug

Magnesium Sulfate 15mg/kg/h

Lidocaine

Drug

Lidocaine 1,5mg/kg/h

Primary outcomes

  1. Sensitive block duration

    Time frame: 9 hours

    Thermal and pinprick level lowering to S2

Secondary outcomes

  1. Motor block duration

    Time frame: 9 hours

    Time to Bromage return to baseline

  2. Two levels regression

    Time frame: 9 hours

    Time from maximal thermal (cold) sensitive block level to lower two levels

  3. Pain at postanesthesia care unit

    Time frame: 1-3 hours

    Maximum pain (0-10 verbal scale) during PACU

Sponsors and collaborators

Lead sponsor

Brasilia University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 30, 2018
Registry last updated
Feb 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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