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Trial record 80 of 1120 for:    Oral Cancer | ( Map: Canada )

Preoperative Oral Dexamethasone to Improve Recovery After Surgery

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ClinicalTrials.gov Identifier: NCT02234466
Recruitment Status : Unknown
Verified September 2014 by Dr. Faisal Siddiqui, University of Manitoba.
Recruitment status was:  Enrolling by invitation
First Posted : September 9, 2014
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Faisal Siddiqui, University of Manitoba

Brief Summary:

Randomized controlled trial of pre-operative oral dexamethasone vs placebo for the improvement of quality of recovery from surgery. The study population is limited to breast surgery patients. The investigators will also look at the effect of our intervention on post operative nausea and vomiting.

Patients will be recruited before the date of their surgery and will complete the Quality of Recovery-40 (QOR-40) questionnaire before their surgery and at 24 hours post op. They will also complete a Clinically significant nausea and vomiting score upon discharge from the post anesthesia recovery room, repeated at 24 hours post op.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Oral dexamethasone Drug: Ondansetron Other: Gelatin capsule Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Preoperative Oral Dexamethasone to Improve Quality of Recovery After Breast Surgery
Study Start Date : August 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : June 2015


Arm Intervention/treatment
Active Comparator: Oral Dexamethasone

Oral dexamethasone- two 4mg tabs and one 2mg tab contained within a gelatin capsule Administered a single time, 2 hours pre-induction

Ondansetron 6mg IV will be administered at skin closure

Drug: Oral dexamethasone
Patients will received their study drug ( or placebo) 2 hours pre-induction. Allowing for the shifting schedules of the OR with the possibility of the previous case finishing early or late, the allowable range is 90-200 minutes pre-induction.
Other Name: Decadron

Drug: Ondansetron
Patients in both groups will receive 6mg IV ondansetron at time of skin closure as their standardized prophylaxis for postoperative nausea and vomiting.
Other Name: Zofran

Other: Gelatin capsule
Gelatin capsule enclosing either dexamethasone tabs or second gelatin capsule

Placebo Comparator: Gelatin pill

Gelatin capsule contained within second gelatin capsule. Administered a single time, 2 hours pre-induction

Ondansetron 6mg IV will be administered at skin closure

Drug: Ondansetron
Patients in both groups will receive 6mg IV ondansetron at time of skin closure as their standardized prophylaxis for postoperative nausea and vomiting.
Other Name: Zofran

Other: Gelatin capsule
Gelatin capsule enclosing either dexamethasone tabs or second gelatin capsule




Primary Outcome Measures :
  1. Change from baseline in Quality of recovery at Post operative day 1 (POD1) [ Time Frame: 24 hours ]
    Quality of recovery as assessed by the QOR-40 will be assessed at POD1, with a baseline measure having been collected immediately pre-operatively.


Secondary Outcome Measures :
  1. Post operative Nausea and Vomiting immediately post operatively [ Time Frame: At discharge from Post Anesthesia Recovery Room, usually within 90 mins to 180 mins after surgery ]
    Assayed by the Clinically Significant Nausea and Vomiting Scale

  2. Post operative Nausea and Vomiting in first 24 hours [ Time Frame: The first 24 hours after surgery ]
    Post operative Nausea and Vomiting as assessed by the Clinically Significant Nausea and Vomiting scale on POD1, assessing the period from surgery until the assessment (not excluding post anesthesia recovery room)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (18 to 80 years of age) undergoing general anesthesia for elective breast surgery (lumpectomy or mastectomy) and providing informed consent.
  • American Society of Anesthesia (ASA) class I, II, & III patients

Exclusion Criteria:

  • ASA class IV and V patients
  • Pregnancy
  • Diabetes
  • History of allergy to any study medications
  • Use of steroids or anti emetics within 1 month of surgery
  • Chronic pain requiring opioid treatment
  • History of alcohol or drug abuse (including smoking tobacco)
  • Severe renal impairment (i.e. serum creatinine more than 160 umol/L)
  • Poor English comprehension or psychiatric/central nervous system disturbance that would preclude completion of the QoR-40 questionnaire

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): NCT02234466


Locations
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Canada, Manitoba
Health Science Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Faisal Siddiqui, MD University of Manitoba

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Responsible Party: Dr. Faisal Siddiqui, Dr. Faisal Siddiqui, MD FRCPC, University of Manitoba
ClinicalTrials.gov Identifier: NCT02234466     History of Changes
Other Study ID Numbers: B2014:004
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by Dr. Faisal Siddiqui, University of Manitoba:
Quality of Recovery (QOR40)
Breast Surgery
Clinically significant Nausea and Vomiting
Postoperative Nausea and Vomiting

Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Ondansetron
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
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents