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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03725228
Other study ID # tccRenato2018
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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