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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
Last Update Posted : November 6, 2017
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

  Show Detailed Description

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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 ondansetrone 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, 2017
Actual Study Completion Date : October 1, 2017


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: The baseline QoR-40 questionnaire will be completed by the subjects after informed consent was obtained in the preoperative holding area and 24 hours after surgery by a blinded investigator. ]
    Quality of recovery will be assessed using the Quality of Recovery Questionnaire (QoR-40) a 40-item quality of recovery scoring system


Secondary Outcome Measures :
  1. Nausea and vomiting (NVPO) [ Time Frame: 24 hours ]
    The occurrence of NVPO will be registered during the PACU and ward stay

  2. Pruritus [ Time Frame: 24 hours ]
    Pruritus will be classified as follow: 0 - no symptoms, 1 - 3 - mild symptoms, 3 - 7 moderate symptoms and 7 - 10 - severe symptoms

  3. Pain [ Time Frame: 24 hours ]
    Pain will be assessed every 15 minutes using a 0-10 numeric pain rating scale (NRS), where zero meant no pain and 10 the worst imaginable pain.



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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] January 1, 2017


Publications:

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Responsible Party: Eduardo Toshiyuki Moro, Assistant Professor, MD, PhD, Pontificia Universidade Catolica de Sao Paulo
ClinicalTrials.gov Identifier: NCT03035942     History of Changes
Other Study ID Numbers: PUCSP 1863886
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
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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Nausea
Vomiting
Pruritus
Fractures, Bone
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Skin Diseases
Skin Manifestations
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Dexamethasone
Dexamethasone acetate
Ondansetron
Morphine
BB 1101
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
Protease Inhibitors
Enzyme Inhibitors