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Quality of Recovery After Dexamethasone, Ondansetron or Placebo Intrathecal Morphine Administration

NCT03035942 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2020-03-19

Study results available
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Summary

The aim of this study is to evaluate not only the occurrence of side effects, but the quality of the recovery (QoR-40 Questionnaire) of patients submitted to spinal anesthesia with administration of low doses (0.1 mg) of intrathecal morphine for the surgical treatment of fractures in one of the lower limbs and who will receive prophylactic ondansetron (4mg), dexamethasone (8mg) or placebo.

Conditions

  • Fractures, Bone
  • Nausea and Vomiting, Postoperative
  • Pruritus
  • Morphine Adverse Reaction
  • Satisfaction, Personal

Interventions

DRUG

Dexamethasone

Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.

DRUG

Ondansetron

Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.

DRUG

Saline

Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.

Sponsors & Collaborators

  • Pontificia Universidade Catolica de Sao Paulo

    lead OTHER

Principal Investigators

  • Eduardo T Moro, Professor · PUC São Paulo University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-02
Primary Completion
2018-10-01
Completion
2019-11-04

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03035942 on ClinicalTrials.gov