Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02305173 |
| Other study ID # |
Dexamethasone-2014-4 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
November 2014 |
| Est. completion date |
November 2016 |
Study information
| Verified date |
September 2023 |
| Source |
Instituto Mexicano del Seguro Social |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Preoperative dexamethasone reduces symptoms after different surgical procedures including
mastectomy in breast cancer, but the effect in the postoperative respiratory function remains
unknown. The aim of this protocol was to determine if the administration of a single dose of
dexamethasone during the preoperative, could improve respiratory function and postoperative
symptoms of patients undergoing mastectomy in breast cancer.
Description:
Controlled clinical trial will be performed in 120 surgical patients treated for breast
cancer, conducted from Nov 2014 to Nov 2015. Patients will be divided in three groups: Group
1 consisted in patients who underwent conservative breast with axillary lymph node
dissection, group 2 in patients with radical mastectomy without reconstruction, and group 3
patients with radical mastectomy with immediate reconstruction with synthetic breast
implants.
All patients will be randomly assigned by a system of sealed envelopes, to receive 8 mg of
intravenous dexamethasone or placebo 60 minutes before surgery. All patients will be female
and had a confirmed diagnosis of breast carcinoma. The investigators will exclude patients
with a classification of the American Society of Anesthesiologists classes III and IV. Other
exclusion criteria are: age 80 years, pregnancy or during menstruation, during steroid
therapy, severe diabetes mellitus (serum HbA1c> 8%); opioids, sedatives or painkillers less
than a week before the mastectomy, or a history of alcohol or drugs. The investigators will
exclude patients with a history of inner ear disease and / or severe PONV after any surgical
procedure performed in the past. All patients will be admitted to hospital one day before
surgery and were followed from hospital admission and until 30 days after surgery for any
medical or surgical morbidity.
Anesthesia and surgery
All patients will be standardized to the next anesthetic protocol:
Under venipuncture, patients receive 1 g of Cephalothin IV one hour before starting the
procedure. After entering the operating room, type 1 continuous monitoring was placed via
noninvasive, Midazolam will be administered via peripheral 0.1-0.2 mg/kg as well as fentanyl
1 mcg / kg IV. Prongs will be placed and basal hemodynamic values will be taken with
preoxygenation by tidal volume technique per minute.
Induction will be performed with Propofol 1-2 mg/kg IV and completed with fentanyl (3 mcg /
kg IV) along with the administration of Rocuronium 0.06 mg/kg IV. Assisted oxygenation
continues at a rate of 5 lpm and laryngeal mask (mask measure according to weight and body
distribution of the patient) is placed.
During surgery, the medication will be completed with omeprazole 40 mg IV, Ondancetron 4 mg
IV. All patients will be monitored with indirect determinations of blood pressure and heart
rate using standard techniques, as well as the content of expired CO2 and oxygen saturation
of the blood. Subsequently, all patients will be extubated and transferred to the unit for
immediate post-surgical care with cardiovascular monitoring and oxygen.
Surgical Procedures All patients will be submitted to treatment according to the clinical
stage with conservative breast surgery with axillary dissection, radical mastectomy without
immediate reconstruction or radical mastectomy with immediate reconstruction with synthetic
implants. In case of radical mastectomy, a closed drainage system will be placed in the
chirurgic region, and will be removed when drainage is less than 50ml in 24 hours.
Chemotherapy or radiation therapy will be administered 3-4 weeks following surgical
resection.
Analgesic and antiemetic therapy Nonsteroidal antiinflammatory drugs will be used as
analgesia after surgery with sodium ketorolac 30 mg IV every 6 hours (in patients younger
than 60 years) or lysine Clonixinate 100 mg IV every 6 hours (in patients older than 60
years). Also, patients who will be submitted to a conservative surgery will receive
intravenous Tramadol 100mg (diluted in 50ml of solution); the dose may be repeated every 12
hours until. Repeated doses of Morphine of 2.5 mg IV will be used in case of radical
mastectomy, according to the needs of the patient. If pain is not diminish within 30 minutes
a VAS will be used and in case the scale is greater than 7, an infusion of 10mg of morphine
in 250ml 0.9% of saline solution will be used. Pain will be assessed on return to the
recovery room and at 6, 12 and 24 h postoperatively using a visual analogue scale (VAS; 0 =
no pain and 10 = most severe pain).
The incidence of PONV will be recorded immediately on return to the recovery room and at 6,
12 and 24 h postoperatively using a three-point ordinal scale (0 = asymptomatic, 1 = feeling
of nausea or tonnage without expulsion oral route of gastric contents 2 = vomiting). Nausea
is defined as a unpleasant sensation associated with awareness of the urge to vomit; retching
is defined as the labored, spasmodic rhythmic contraction of the respiratory muscles without
the expulsion of gastric contents, and vomiting is defined as the forceful expulsion of
gastric contents from the mouth. Ondancetron will be used IV (4-8 mg) to treat these
symptoms.
Pulmonary Function. To perform a spirometry, the ambient must comply the following
characteristics: environment without audio or visual shocks and thermal comfort for the
comfort of the patient. Patients will be told to sit in a comfortable position with your back
straight (at an angle greater than 45°, to patient tolerance) and high chin. Lightweight
support will be perform in the patient by taking her gently by the shoulders to keep them
lean forward and off balance grew. In the immediate postoperative and due to postoperative
pain, the patient will be settled in the stretcher to emulate the sitting position
(inclination greater than 45 °) performing the previously mentioned subject. The nature of
the study will be explained in understandable language to the patient, and their cooperation
will be requested. Forced espiratory maneuver will be explained and immediately exemplified
by the best qualified to understand the patient and to avoid measurement bias evaluator.
Special emphasis will be placed on the importance of starting the effort with the maximum
volume of air in the lungs, so determined and energetic, as well as maintaining exhalation as
long as possible. She will be asked to take the disposable cardboard mouthpiece adaptable to
pneumotachograph, sealing it with the lips in the position of maximal inspiration and then
blow air through it, initiating a sharp exhalation maneuver with the above characteristics.
To be a valid test, the maneuver should be performed with a proper effort, starting from the
position of maximal inspiration without hesitation or false start with a continuous
exhalation without corrections, cough or Valsalva maneuver, as well as checking for leaks
were recorded in nozzle. A total of three satisfactory maneuvers will be performed with a
maximum of eight attempts for each measurement, spaced at least for 30 seconds. To perform
the study, a "Fleisch spirometer" with brand Sibelmed® neumotac type model will be used
Datospir 110/120.
Measurements of forced espiratory volume in one second (FEV1), forced vital capacity (FVC)
Maximum Forced Espiratory Flow (FEFM) and the ratio between forced espiratory volume in one
second and forced vital capacity will be taken into account (FEV1 / FVC). Such clinical
parameters are directly related to muscle fatigue, the compliance of the lung parenchyma and
respiratory status of patients.
Statistical Analysis Postoperative complications will be recorded during hospitalization and
patients will be followed up to 30 days after hospital discharge. Data collected will include
patient age, body mass index (BMI), smoking history and neoadjuvant chemotherapy, anesthesia
and operation time and the frequency of use of analgesics and antiemetics. These parameters
will be added and compared between dexamethasone and placebo groups. The endpoints of the
study will be postoperative nausea and vomiting, and pain measured by the VAS and the need
for additional analgesia and antiemetic drugs as described.
The sample size was predetermined. The investigators expect a 35% difference in the incidence
of nausea and vomiting between groups. The α error 0.05 and β error 0.20; n = 35 patients in
each group will be considered adequate, according to an analysis of power. All results eill
be expressed as percentages and means with standard deviation ± (SD). Student t test, Chi 2
of Fisher's exact test will be used to analyze quantitative and qualitative data,
respectively. Differences will be considered statistically significant at p <0.05.
Ethical Considerations This protocol has been registered with the Local Research and Ethics
Committee on Health.
The study will be conducted according to the principles of the Helsinki Declaration of 1989,
and with the Guidelines of Health of Mexico. The local research and ethics committee of
Health Research Ethics Committees of the Cancer Institute of Jalisco, Mexico approved all
protocols. A full written informed consent will be obtained from all patients before
inclusion in the study.
