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

• Status: Completed
• Trial end date: 2019-11-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pontificia Universidade Catolica de Sao Paulo
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Morphine; Ondansetron

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.