Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.

NCT03301025 | Completed DMC

• 1 other identifier: R/17.07.107
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

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.

Conditions

Spine Surgery

Keywords

Pregabalin, hypotensive anesthesia, blood loss, analgesia

Outcome Measures

Primary Outcomes (1)

• Nitroglycerin consumption

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

  Intraoperative

Secondary Outcomes (12)

• Estimated blood loss

  intraoperative

• The number of transfused blood unites

  intraoperative

• 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.

• end-tidal isoflurane concentration

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

• Surgeon satisfaction about the field

  within 2 hours from the end of surgery.

Study Arms (2)

Pregabalin group

ACTIVE COMPARATOR

(n=53):

Drug: Pregabalin

placebo group

PLACEBO COMPARATOR

(n=53):

Drug: placebo

Interventions

Pregabalin DRUG

Pregabalin 150 mg capsule, one h preinduction of general anesthesia

Also known as: (LYRICA® 150 mg capsule- PFIZER)

Pregabalin group

placebo DRUG

given a placebo identical capsule once one hour before anesthesia

Also known as: control

placebo group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (2)

Delta Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Hemorrhage; Agnosia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Alaa Mazy

  Faculty of Medicine, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 4, 2017
• Study Start: January 8, 2018
• Primary Completion: March 30, 2018
• Study Completion: April 30, 2019
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: e mail: alaa\ mazy@yahoo.com

Locations

EG (2)