Preoperative Oral Dexamethasone to Improve Recovery After Surgery

NCT02234466 | Unknown Phase 2

• 1 other identifier: B2014:004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Quality of Recovery (QOR40); Breast Surgery; Clinically significant Nausea and Vomiting; Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Quality of recovery at Post operative day 1 (POD1)

  Quality of recovery as assessed by the QOR-40 will be assessed at POD1, with a baseline measure having been collected immediately pre-operatively.

  24 hours

Secondary Outcomes (2)

• Post operative Nausea and Vomiting immediately post operatively

  At discharge from Post Anesthesia Recovery Room, usually within 90 mins to 180 mins after surgery

• Post operative Nausea and Vomiting in first 24 hours

  The first 24 hours after surgery

Study Arms (2)

Oral Dexamethasone

ACTIVE COMPARATOR

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; Drug: Ondansetron; Other: Gelatin capsule

Gelatin pill

PLACEBO COMPARATOR

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; Other: Gelatin capsule

Interventions

Oral dexamethasone DRUG

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.

Also known as: Decadron

Oral Dexamethasone

Ondansetron DRUG

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

Also known as: Zofran

Gelatin pill; Oral Dexamethasone

Gelatin capsule OTHER

Gelatin capsule enclosing either dexamethasone tabs or second gelatin capsule

Gelatin pill; Oral Dexamethasone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Science Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Vomiting; Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Calcium Dobesilate; Ondansetron; Gelatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Faisal Siddiqui, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Faisal Siddiqui, MD FRCPC

Study Record Dates

• First Submitted: August 31, 2014
• First Posted: September 9, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

CA (1)