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Completed

NCT Number: NCT03301025

Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.

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.

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Key information

Conditions

Spine Surgery Agnosia Hemorrhage Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Delta Hospital, Al Mansurah, Dakahlia Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

Pregabalin 150 mg capsule, one h preinduction of general anesthesia

Other names: (LYRICA® 150 mg capsule- PFIZER)

Placebo

Drug

given a placebo identical capsule once one hour before anesthesia

Other names: control

Primary outcomes

  1. Nitroglycerin consumption

    Time frame: Intraoperative

    the total nitroglycerin consumption in milligram to maintain the target mean arterial pressure (MAP) 55- 65 mmHg.

Secondary outcomes

  1. Estimated blood loss

    Time frame: intraoperative

    towels are weighted, plus suction volume without irrigation fluids in milliter.

  2. The number of transfused blood unites

    Time frame: intraoperative

    Packed red blood cell unites

  3. heart rate (HR)

    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.

    in beat/min

  4. end-tidal isoflurane concentration

    Time frame: at 30, 60, 90, 120, 150 , 180, 210 minutes after intubation.

    in percent

  5. Surgeon satisfaction about the field

    Time frame: within 2 hours from the end of surgery.

    using a six-point scale (0 = no bleeding, virtually bloodless field; 5 = uncontrolled) bleeding).

  6. Sedation

    Time frame: at 0, 2, 4, 6, 12, 24 hours postoperatively

    (Ramsay sedation scale)

  7. The time to the first request of analgesia.

    Time frame: 24 hours postoperative

    in hours

  8. Postoperative pain

    Time frame: at 0, 2, 4, 6, 12, 24 hours postoperatively.

    (VAS 0-10 scale) 10 is the worst pain

  9. The total morphine consumption

    Time frame: in the 1st 24 hours postoperatively

    in mg

  10. Frequency of adverse effects

    Time frame: during the first 24 hours postoperatively

    dizziness, headache, nausea and vomiting, or pruritus.

  11. Peak airway pressures

    Time frame: 10 minutes after settled prone position

    in centimeter water

  12. invasive mean arterial blood pressure (MAP)

    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.

    in millimeter mercury (mmHg)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Oct 4, 2017
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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