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

Phase 4

Completed

• Conditions: Anesthesia; Pain
• Interventions: Drug: Magnesium Sulfate; Drug: Lidocaine

• Registration Number: NCT03725228
• Lead Sponsor: Brasilia University Hospital

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.

Study Timeline

• Study First Submitted: 2018-10-27
• Study First Submitted QC: 2018-10-27
• Study First Posted: 2018-10-30
• Study Start: 2018-11-07
• Primary Completion: 2019-02-01
• Study Completion: 2019-04-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium Sulfate	Magnesium Sulfate	Continuous intravenous infusion of 15mg/kg/h of magnesium sulfate, starting just after spinal anesthesia infusion until the end of surgery
Lidocaine	Lidocaine	Continuous intravenous infusion of 1.5mg/kg/h of lidocaine, starting just after spinal anesthesia infusion until the end of surgery

Primary Outcome Measures

Name	Time	Method
Sensitive block duration	9 hours	Thermal and pinprick level lowering to S2

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Universitário de Brasilia; 🇧🇷 Brasilia, Distrito Federal, Brazil