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CompletedNCT03725228Updated Feb 27, 2020

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

A Phase 4 interventional study of Magnesium Sulfate and Lidocaine in Anesthesia and Pain, sponsored by Brasilia University Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2020-02-27.

Sponsored by Brasilia University Hospital · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Anesthesia
  • Pain

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03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's enrollment of 44 is below the median of 66 across 8,493 interventional studies indexed under Pain.

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Lead sponsor

Brasilia University Hospital is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Will receive spinal anesthesia for TURP por Histerectomy

Exclusion criteria

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).
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
44 participants (actual)

Study arms

  • 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

  • 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

Interventions

06

What researchers measure

Primary outcomes

  1. Sensitive block duration

    Thermal and pinprick level lowering to S2

    Time frame: 9 hours

Secondary outcomes

  1. Motor block duration

    Time to Bromage return to baseline

    Time frame: 9 hours

  2. Two levels regression

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

    Time frame: 9 hours

  3. Pain at postanesthesia care unit

    Maximum pain (0-10 verbal scale) during PACU

    Time frame: 1-3 hours

07

Study locations

1 site
  • Hospital Universitário de Brasilia
    Brasilia, Distrito Federal 70000000, Brazil
08

References and documents

Individual participant data

Plan to share: Yes — We plan to share de-identified IPD in Mendeley Data after study completion

Supporting information: Analytic code

Time frame: Analystic code will be published in RPUBS

Access criteria: Open Access

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03725228
Lead sponsor
Brasilia University Hospital
Responsible party
Gabriel Magalhaes Nunes Guimaraes (Head of Anesthesia, Brasilia University Hospital) — Principal investigator
First posted
Oct 30, 2018
Start date
Nov 7, 2018
Primary completion
Feb 1, 2019
Completion
Apr 1, 2019
Last update
Feb 27, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Lidocaine

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