Clinical trial NCT03301025: Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.
Official title: Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Surgery
Keywords: Pregabalin, hypotensive anesthesia, blood loss, analgesia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) score I-II
* admitted to undergo lumbar discectomy or spinal fixation surgery under general anesthesia

Exclusion Criteria:

* 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

Primary outcomes:
measure: Nitroglycerin consumption
timeFrame: Intraoperative
Secondary outcomes:
measure: Estimated blood loss
timeFrame: intraoperative
measure: The number of transfused blood unites
timeFrame: intraoperative
measure: heart rate (HR)
timeFrame: Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.
measure: end-tidal isoflurane concentration
timeFrame: at 30, 60, 90, 120, 150 , 180, 210 minutes after intubation.
measure: Surgeon satisfaction about the field
timeFrame: within 2 hours from the end of surgery.
measure: Sedation
timeFrame: at 0, 2, 4, 6, 12, 24 hours postoperatively
measure: The time to the first request of analgesia.
timeFrame: 24 hours postoperative
measure: Postoperative pain
timeFrame: at 0, 2, 4, 6, 12, 24 hours postoperatively.
measure: The total morphine consumption
timeFrame: in the 1st 24 hours postoperatively
measure: Frequency of adverse effects
timeFrame: during the first 24 hours postoperatively
measure: Peak airway pressures
timeFrame: 10 minutes after settled prone position
measure: invasive mean arterial blood pressure (MAP)
timeFrame: Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.
Other outcomes:
Locations:
city: Mansourah,
country: Egypt
facility: Delta Hospital
state: Dakahlia
city: Mansourah
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
Study officials:
affiliation: Faculty of Medicine, Mansoura University
name: Alaa Mazy
role: PRINCIPAL_INVESTIGATOR
References: