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

NCT ID: NCT03725228

Last Updated: 2020-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-07
• Study Completion Date: 2019-04-01

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.

Conditions

Anesthesia; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Magnesium Sulfate

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

Group Type: ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type: DRUG

Magnesium Sulfate 15mg/kg/h

Lidocaine

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

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

Lidocaine 1,5mg/kg/h

Interventions

Magnesium Sulfate

Magnesium Sulfate 15mg/kg/h

Intervention Type: DRUG

Lidocaine

Lidocaine 1,5mg/kg/h

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brasilia University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gabriel Magalhaes Nunes Guimaraes

Head of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitário de Brasilia

Brasília, Federal District, Brazil

Countries

Brazil

Other Identifiers

tccRenato2018

Identifier Type: -

Identifier Source: org_study_id