Phase 4 N=135 Randomized Quadruple-blind Prevention

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

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

Bottom Line

View on ClinicalTrials.gov: NCT03035942 ↗

Enrolled (actual)

135

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Quality of Recovery — 184; 187; 185 Score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dexamethasone (Drug); Ondansetron (Drug); Saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pontificia Universidade Catolica de Sao Paulo
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Quality of Recovery	184; 187; 185	—
SECONDARY Nausea and Vomiting During PACU Staying	3; 9; 9	—
SECONDARY Number of Participants With Pruritus	4; 7; 8	—
SECONDARY Pain During Postanesthesia Care Unit and Ward Stay (Numeric Rating Scale - NRS)	0; 5; 2	—

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.

Eligibility Criteria

Inclusion Criteria

ASA physical status I or II, who will scheduled to undergo surgical treatment of lower limb fractures

Exclusion Criteria

Patients who:

(i) refused to participate in the study;

(ii) were not able to communicate due to alterations in the level of consciousness, or neurologic, or psychiatric disease;

(iii) presented with contraindication to any of the drugs used in the present study;

(iv) had history of alcohol or drug abuse and

(v) had surgery in the last 10 days were excluded.

Reasons for exclusion after randomisation will be protocol violations or if the anesthesia technique was changed from a spinal to a general approach.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03035942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.