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.

Study Overview

• Status: Completed
• Conditions: Pain; Anesthesia
• Intervention / Treatment: Drug: Magnesium Sulfate; Drug: Lidocaine

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 70000000
      • Hospital Universitário de Brasília

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Magnesium Sulfate; Continuous intravenous infusion of 15mg/kg/h of magnesium sulfate, starting just after spinal anesthesia infusion until the end of surgery	Drug: Magnesium Sulfate; Magnesium Sulfate 15mg/kg/h
Experimental: Lidocaine; Continuous intravenous infusion of 1.5mg/kg/h of lidocaine, starting just after spinal anesthesia infusion until the end of surgery	Drug: Lidocaine; Lidocaine 1,5mg/kg/h

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brasilia University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: October 27, 2018
• First Submitted That Met QC Criteria: October 27, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Lidocaine; Magnesium Sulfate
• Other Study ID Numbers: tccRenato2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We plan to share de-identified IPD in Mendeley Data after study completion
• IPD Sharing Time Frame: Analystic code will be published in RPUBS
• IPD Sharing Access Criteria: Open Access
• IPD Sharing Supporting Information Type: Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No