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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725228
• Other study ID #: tccRenato2018
• Status: Completed
• Phase: Phase 4
• Start date: November 7, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: February 2020
• Source: Brasilia University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anesthesia
• Pain

Intervention

Drug:
• Magnesium Sulfate
Magnesium Sulfate 15mg/kg/h
• Lidocaine
Lidocaine 1,5mg/kg/h

Locations

Country	Name	City	State
Brazil	Hospital Universitário de Brasilia	Brasilia	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia University Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitive block duration	Thermal and pinprick level lowering to S2	9 hours
Secondary	Motor block duration	Time to Bromage return to baseline	9 hours
Secondary	Two levels regression	Time from maximal thermal (cold) sensitive block level to lower two levels	9 hours
Secondary	Pain at postanesthesia care unit	Maximum pain (0-10 verbal scale) during PACU	1-3 hours