NCT03725228

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

November 7, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

October 27, 2018

Last Update Submit

February 26, 2020

Conditions

AnesthesiaPain

Outcome Measures

Primary Outcomes (1)

  • Sensitive block duration

    Thermal and pinprick level lowering to S2

    9 hours

Secondary Outcomes (3)

  • Motor block duration

    9 hours

  • Two levels regression

    9 hours

  • Pain at postanesthesia care unit

    1-3 hours

Study Arms (2)

Magnesium Sulfate

ACTIVE COMPARATOR

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

Drug: Magnesium Sulfate

Lidocaine

EXPERIMENTAL

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

Drug: Lidocaine

Interventions

Magnesium SulfateDRUG

Magnesium Sulfate 15mg/kg/h

Magnesium Sulfate
LidocaineDRUG

Lidocaine 1,5mg/kg/h

Lidocaine

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Will receive spinal anesthesia for TURP por Histerectomy

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitário de Brasilia

Brasília, Federal District, 70000000, Brazil

Location

MeSH Terms

Conditions

Pain

Interventions

Magnesium SulfateLidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesia

Study Record Dates

First Submitted

October 27, 2018

First Posted

October 30, 2018

Study Start

November 7, 2018

Primary Completion

February 1, 2019

Study Completion

April 1, 2019

Last Updated

February 27, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

We plan to share de-identified IPD in Mendeley Data after study completion

Shared Documents
ANALYTIC CODE
Time Frame
Analystic code will be published in RPUBS
Access Criteria
Open Access

Locations

BR(1)