Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.

NCT ID: NCT03301025

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2019-04-30

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.

Conditions

Spine Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Pregabalin group

(n=53):

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

Pregabalin 150 mg capsule, one h preinduction of general anesthesia

placebo group

(n=53):

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

given a placebo identical capsule once one hour before anesthesia

Interventions

Pregabalin

Pregabalin 150 mg capsule, one h preinduction of general anesthesia

Intervention Type: DRUG

placebo

given a placebo identical capsule once one hour before anesthesia

Intervention Type: DRUG

Other Intervention Names

(LYRICA® 150 mg capsule- PFIZER); control

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mazy Mazy

Associate professor of anesthesia and surgical intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa Mazy

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Mansoura University

Locations

Delta Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

R/17.07.107

Identifier Type: -

Identifier Source: org_study_id