NCT03386565

Brief Summary

Fifty patients were included in the study, divided into two equal groups (25 in each), underwent spinal fusion surgery.Control group: received normal saline. Lidocaine group: received lidocaine 2.0 mg/kg slowly IV before induction of anesthesia, followed by lidocaine IV infusion at a rate of 2.5 mg/kg/hr until the end of surgery. We evaluated the end-tidal isoflurane concentration required to maintain AAI index in the range of 20-25 during adult spinal fusion surgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

December 17, 2017

Last Update Submit

December 21, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • effect of intraoperative IV lidocaine infusion on intraoperative end tidal isoflurane concentration

    using gas analyzer for determination of end tidal isoflurane concentration (%) (ET-Iso) needed to maintain AAI index in the range 20-25.

    every 15 minutes from induction of anesthesia until 90 minutes intraoperative.

Study Arms (2)

control group

ACTIVE COMPARATOR

* Sodium chloride solution 10 mL IV just before induction of anesthesia * IV infusion during the surgery

Drug: sodium chloride solution

lidocaine group

ACTIVE COMPARATOR

* lidocaine 2 mg ̸ kg slowly IV just before induction of anesthesia * IV infusion during the surgery

Drug: Lidocaine

Interventions

intraoperative IV infusion

Also known as: normal saline solution
control group

intraoperative IV infusion

Also known as: xylocaine
lidocaine group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients underwent spinal fusion surgery ASA I, II and III

You may not qualify if:

  • History of epilepsy hearing disorders known allergy to lidocaine BMI \> 35 significant cardiac diseases significant renal diseases liver dysfunction substance abuse chronic opioid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Vesal N, Spadavecchia C, Steiner A, Kirscher F, Levionnois OL. Evaluation of the isoflurane-sparing effects of lidocaine infusion during umbilical surgery in calves. Vet Anaesth Analg. 2011 Sep;38(5):451-60. doi: 10.1111/j.1467-2995.2011.00636.x.

    PMID: 21831050BACKGROUND
  • Saadawy IM, Kaki AM, Abd El Latif AA, Abd-Elmaksoud AM, Tolba OM. Lidocaine vs. magnesium: effect on analgesia after a laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 2010 May;54(5):549-56. doi: 10.1111/j.1399-6576.2009.02165.x. Epub 2009 Nov 16.

    PMID: 19919581BACKGROUND

MeSH Terms

Interventions

Sodium ChlorideSaline SolutionLidocaine

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 17, 2017

First Posted

December 29, 2017

Study Start

October 2, 2016

Primary Completion

October 2, 2017

Study Completion

December 15, 2017

Last Updated

December 29, 2017

Record last verified: 2017-12