Elective lumbar spine surgical procedures are commonly performed under controlled hypotension during general anesthesia. That is beneficial to limit the intraoperative blood loss and transfusions and improves surgical field. Deliberate hypotension could be achieved via various medications but mostly associated with significant side effects. Pregabalin effectively augmented hypotensive anesthesia. The hypothesis is that Pregabalin 150 mg single preoperative dose may augment intraoperative deliberate hypotension that will be reflected on blood loss and nitroglycerin consumption.
An arterial line will be established then general anesthesia will be conducted. After adequate preoxygenation, anesthesia induction by IV fentanyl 1.5µg/kg, propofol 2 mg/kg, and atracurium 0.5 mg/kg then appropriated size tracheal tube. The ventilator settings will be adjusted to maintain the end-tidal carbon dioxide tension (ETco2) at 30-35 mm Hg. Anesthesia will be maintained by isoflurane concentration 1.2%, with 40% oxygen in air then IV infusion of fentanyl 0.05 mcg/kg/min was started while atracurium 0.1 mg/kg incremental dose as required. Then patients will be turned into the prone position above pad support permitting free hanging of the abdomen. Intraoperatively, the target mean arterial arterial blood pressure (MBP) is 55-65 mm Hg. After surgical incision, if MBP exceeds 65 mm Hg (defined as hypertension) it will be managed by: increasing isoflurane MAC up to 2%, if no response after 5 min, Nitroglycerin infusion initiated at 0.5 mcg/kg/min to 40 mcg/kg/min. Hypotension (MBP \<55 mm Hg) will be treated by stopping nitroglycerin, proper compensation of losses, reducing Isoflurane MAC. If persisted; vasoactive drugs will be used. Bradycardia (HR \<50 beat/min.), treated with 0.01 mg/kg atropine IV increments. The nitroglycerin infusion will be stopped after the finial surgical hemostasis. Fentanyl infusion will be stopped before ligament sutures. Isoflurane will be closed after the last surgical suture. After dressing, patient will be turned to the supine position and morphine 0.025 mg/kg IV will be administered then 0.04 mg/kg neostigmine and 0.015 mg/kg atropine for reversal. Extubation will be done after establishment of acceptable spontaneous respiration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
Pregabalin 150 mg capsule, one h preinduction of general anesthesia
given a placebo identical capsule once one hour before anesthesia
Delta Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Nitroglycerin consumption
the total nitroglycerin consumption in milligram to maintain the target mean arterial pressure (MAP) 55- 65 mmHg.
Time frame: Intraoperative
Estimated blood loss
towels are weighted, plus suction volume without irrigation fluids in milliter.
Time frame: intraoperative
The number of transfused blood unites
Packed red blood cell unites
Time frame: intraoperative
heart rate (HR)
in beat/min
Time frame: Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.
end-tidal isoflurane concentration
in percent
Time frame: at 30, 60, 90, 120, 150 , 180, 210 minutes after intubation.
Surgeon satisfaction about the field
using a six-point scale (0 = no bleeding, virtually bloodless field; 5 = uncontrolled) bleeding).
Time frame: within 2 hours from the end of surgery.
Sedation
(Ramsay sedation scale)
Time frame: at 0, 2, 4, 6, 12, 24 hours postoperatively
The time to the first request of analgesia.
in hours
Time frame: 24 hours postoperative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
106
Postoperative pain
(VAS 0-10 scale) 10 is the worst pain
Time frame: at 0, 2, 4, 6, 12, 24 hours postoperatively.
The total morphine consumption
in mg
Time frame: in the 1st 24 hours postoperatively
Frequency of adverse effects
dizziness, headache, nausea and vomiting, or pruritus.
Time frame: during the first 24 hours postoperatively
Peak airway pressures
in centimeter water
Time frame: 10 minutes after settled prone position
invasive mean arterial blood pressure (MAP)
in millimeter mercury (mmHg)
Time frame: Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.