CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 135 enrolled
Drug / intervention
Dexamethasone +2 moredrug
Likely dose
Dexamethasone 8 mg IV or Ondansetron 4 mg IV administered immediately after spinal anesthesiaAI-extracted
Key inclusion· 2
  • ✓ASA physical status I or II
  • ✓Scheduled for surgical treatment of lower limb fractures
Key exclusion· 6
  • ✕Refusal to participate
  • ✕Unable to communicate due to alterations in level of consciousness, neurologic disease, or psychiatric disease
  • ✕Contraindication to any of the drugs used in the study
  • ✕History of alcohol or drug abuse

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03035942
NCT03035942Phase 4Completed
CompareCT.gov

Role of Dexamethasone or Ondansetron in the Quality of Recovery After Intrathecal Morphine Administration in Patients Undergoing Lower Limb Surgery.

Pontificia Universidade Catolica de Sao Paulo·interventional·Posted Jan 30, 2017·Updated Mar 19, 2020

In Brief

A Phase 4 clinical trial evaluating Dexamethasone, Ondansetron, and 1 other intervention for Fractures, Bone and 4 related conditions. Completed, enrolled 135 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFractures, Bone, Nausea and Vomiting, Postoperative, Pruritus, Morphine Adverse Reaction, Satisfaction, Personal
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 30, 2017
Enrollment StartJan 2, 2017
Primary CompletionOct 1, 2018
Study CompletionNov 4, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.4 years ago

Interventions

Dexamethasonedrug

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.

Ondansetrondrug

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.

Salinedrug

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.