Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.
- Registration Number
- NCT03301025
- Lead Sponsor
- Mansoura University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- American Society of Anesthesiologists (ASA) score I-II
- admitted to undergo lumbar discectomy or spinal fixation surgery under general anesthesia
- Patients on anti-hypertensive treatment, diuretics, corticosteroids, pregabalin, gabapentin, anticonvulsants, antipsychotics,
- alcohol addiction or drug abuse
- patients with history of allergy to any drug used in the study .
- pregnant or nursing women
- patients with peripheral neuropathy, endocrinal diseases, bleeding abnormality,
- cardiac, hepatic or renal impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pregabalin group Pregabalin (n=53): placebo group placebo (n=53):
- Primary Outcome Measures
Name Time Method Nitroglycerin consumption Intraoperative the total nitroglycerin consumption in milligram to maintain the target mean arterial pressure (MAP) 55- 65 mmHg.
- Secondary Outcome Measures
Name Time Method Estimated blood loss intraoperative towels are weighted, plus suction volume without irrigation fluids in milliter.
end-tidal isoflurane concentration at 30, 60, 90, 120, 150 , 180, 210 minutes after intubation. in percent
The time to the first request of analgesia. 24 hours postoperative in hours
Peak airway pressures 10 minutes after settled prone position in centimeter water
invasive mean arterial blood pressure (MAP) Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours. in millimeter mercury (mmHg)
Frequency of adverse effects during the first 24 hours postoperatively dizziness, headache, nausea and vomiting, or pruritus.
Surgeon satisfaction about the field within 2 hours from the end of surgery. using a six-point scale (0 = no bleeding, virtually bloodless field; 5 = uncontrolled) bleeding).
Sedation at 0, 2, 4, 6, 12, 24 hours postoperatively (Ramsay sedation scale)
The number of transfused blood unites intraoperative Packed red blood cell unites
heart rate (HR) Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours. in beat/min
Postoperative pain at 0, 2, 4, 6, 12, 24 hours postoperatively. (VAS 0-10 scale) 10 is the worst pain
The total morphine consumption in the 1st 24 hours postoperatively in mg
Trial Locations
- Locations (2)
Mansoura University Hospital
🇪🇬Mansourah, Dakahlia, Egypt
Delta Hospital
🇪🇬Mansourah,, Dakahlia, Egypt