This study will be performed in the FAYOUM University Hospital after the local
Institutional Ethics Committee and local institutional review board approval. Newly
diagnosed and pathologically proven breast cancer patients who are prepared for elective
breast cancer surgery will be recruited from the general surgery department of our
hospital. The study design will be prospective observational study. A detailed informed
consent will be signed by the eligible patients before recruitment.
Measurement of vitamin D:
The characteristics of 25 (OH) D3 are relatively longer half-life than 1.25 (OH)2 D3,
stability, strong detection repeatability, and no biological activity. Generally,
systemic levels of the more stable 25 (OH) D3 are considered to be the best index to
reflect status of vitamin D in the individual patient .
study design:
Serum 25(OH)D levels will be measured preoperative . Patients will be divided into two
groups :
(1) group D: vitamin D-deficient group (<30nmol/L); and (2) group S: vitamin D-sufficient
group (≥30nmol/L) .
Randomization:
Preoperative serum 25(OH) D levels will be assessed by an anaesthesiologist who will not
be included in the study, to get the number of patients required in each group.
Randomization will be done via computer-generated random numbers that will be placed in
separate closed envelopes and will be opened by study investigators just after induction
of general anaesthesia. Neither the patients, the study investigators, the attending
clinicians nor the data collectors will be aware of the allocation of groups till the
study ends. The patients will be allocated in 1:1 ratio to one of the two groups: group
D: vitamin D-deficient group (n= 92 ), and group S: vitamin D-sufficient group (n= 92).
Anaesthesia procedure:
All patients will undergo routine preoperative investigations; CBC, coagulation profile,
liver function tests, kidney function tests, ECG and preoperative serum 25(OH)D level.
Upon arrival to the operating room, standard monitors (5-lead electrocardiogram, pulse
oximeter, noninvasive blood pressure monitoring) will be applied and continue all over
the operation. An IV access will be established. All patients will receive IV ondansetron
4 mg before induction of anesthesia as a premedication. General anesthesia will be
performed as follows: induction using IV propofol (2mg/kg), atracurium (0.5mg/kg), and
fentanyl (1 microgram/kg). A cuffed endotracheal tube (7mm ID) will be placed to secure
the airway. Mechanical ventilation parameters will be adjusted to ensure proper
oxygenation and ventilation with normocapnia. Maintenance of anesthesia will be made
using inhalational anesthesia with isoflurane 1.5% volume concentration and IV atracurium
(0.1 mg/kg) every 20 minutes. Continuous hemodynamic monitoring of blood pressure and
heart rate will be done . If the systolic blood pressure decreased to a 20% below the
baseline or less than 90 mmHg, 5 mg of ephedrine will be injected IV. Moreover, if the
heart rate reduced to a 50 bpm or less, 0.5 mg of atropine will be injected IV. At the
end of operation , the patients will be transferred to the postoperative anaesthesia care
unit for routine monitoring and then to the general surgery department when they have a
modified Aldrete score ≥9.
Postoperative Pain Management:
Throughout the first 24 hrs, patients will receive IV paracetamol 1 g every 8 hrs for
postoperative analgesia according to the general surgery department protocol.
They also will receive IV tramadol through a patient controlled analgesia (PCA) system
(concentration of 4 mg/mL); with; a 20 mg dose, a 10 mins lockout interval and a 50 mg 1
hr limit as supplementary analgesia with no background analgesia.
