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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03035942
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Eduardo Toshiyuki Moro, Pontificia Universidade Catolica de Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Fractures, Bone Nausea and Vomiting, Postoperative Pruritus Morphine Adverse Reaction Satisfaction, Personal Drug: Dexamethasone Drug: Ondansetron Drug: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, controlled, double-blinded
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Group assignments will be sealed in sequentially numbered opaque envelopes that were opened after patient inclusion in the study. All care providers, researchers, and patients will be blinded to group assignments. Study 5-mL syringes will be prepared by a nurse independent of the study. Normal saline (5 mL total volume), dexamethasone (made up to 5 mL with normal saline), or 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.
Primary Purpose: Prevention
Official Title: Role of Dexamethasone or Ondansetron in the Quality of Recovery After Intrathecal Morphine Administration in Patients Undergoing Lower Limb Surgery.
Actual Study Start Date : January 2, 2017
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : November 4, 2019


Arm Intervention/treatment
Experimental: D Group
Dexamethasone 8 mg
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.
Other Name: D Group

Experimental: O group
Ondansetron 4 mg
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.
Other Name: O Group

Placebo Comparator: S group
Normal saline (5 mL total volume)
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.
Other Name: Placebo Group




Primary Outcome Measures :
  1. Quality of Recovery [ Time Frame: Twenty four hours after surgery by a blinded investigator ]
    Quality of Recovery Questionnaire (QoR-40). Minimum score 40 (very poor quality of recovery) and maximun score 200 (excellent quality of recovery). Higher scores mean better outcome


Secondary Outcome Measures :
  1. Nausea and Vomiting During PACU Staying [ Time Frame: 4h ]
    The occurrence of PONV will be registered during the PACU

  2. Number of Participants With Pruritus [ Time Frame: 24 hours ]
    The occurrence of localized or generalized itching (patients who answered yes or no)

  3. Pain During Postanesthesia Care Unit and Ward Stay (Numeric Rating Scale - NRS) [ Time Frame: 24 hours ]
    Pain were assessed every 15 minutes during postanesthesia care unit, where zero meant no pain and 10 the worst imaginable pain (higher values represent worse outcome). Twenty four hours after surgery, patients were asked to describe the highest pain score (NRS) during ward stay.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035942


Locations
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Brazil
Santa Lucinda Hospital
Sorocaba, SP, Brazil, 18030-230
Sponsors and Collaborators
Pontificia Universidade Catolica de Sao Paulo
Investigators
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Principal Investigator: Eduardo T Moro, Professor PUC São Paulo University
  Study Documents (Full-Text)

Documents provided by Eduardo Toshiyuki Moro, Pontificia Universidade Catolica de Sao Paulo:
Statistical Analysis Plan  [PDF] February 1, 2018
Study Protocol  [PDF] June 1, 2016

Publications:

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Responsible Party: Eduardo Toshiyuki Moro, Assistant Professor, MD, PhD, Pontificia Universidade Catolica de Sao Paulo
ClinicalTrials.gov Identifier: NCT03035942    
Other Study ID Numbers: PUCSP 1863886
First Posted: January 30, 2017    Key Record Dates
Results First Posted: March 19, 2020
Last Update Posted: March 19, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eduardo Toshiyuki Moro, Pontificia Universidade Catolica de Sao Paulo:
Intrathecal morphine
Nausea and vomiting
Quality of recovery
Patient satisfaction
Pruritus
Postoperative pain
Additional relevant MeSH terms:
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Pruritus
Nausea
Vomiting
Postoperative Nausea and Vomiting
Fractures, Bone
Signs and Symptoms, Digestive
Signs and Symptoms
Skin Diseases
Skin Manifestations
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Dexamethasone
Ondansetron
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents