NCT01986309

Brief Summary

There some evidence regarding the effect of lidocaine for the prevention of nausea and vomiting in adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

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

March 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
Last Updated

September 24, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

July 8, 2013

Last Update Submit

September 22, 2015

Conditions

Postoperative Nausea and VomitingPain

Keywords

PostoperativeNauseaVomitingPainSurgery

Outcome Measures

Primary Outcomes (1)

  • Evaluating the effectiveness of intravenous lidocaine during anesthesia to decrease the numbers of events (vomiting) during the immediate postoperative period up to 24 hours postoperatively, comparing to placebo

    24 hours

Secondary Outcomes (12)

  • The prevention of the composite "nausea / or vomiting"

    24 hours

  • Compare frequency of vomiting by baseline risk

    24 hours

  • Time to first vomiting

    24 hours

  • Time at which discharge criteria are met Postanesthesia care unit (PACU)

    24 hours

  • Length of stay in PACU unit

    24 hours

  • +7 more secondary outcomes

Study Arms (2)

Group L

ACTIVE COMPARATOR

Group L Lidocaine load dose 1.5 mg / kg over 5 minutes, followed by continuous infusion of 2 mg / kg / h, which is maintained until the end of surgical procedure

Drug: Lidocaine

Group P

PLACEBO COMPARATOR

Normal saline solution administered under the same regimen

Drug: Normal saline

Interventions

LidocaineDRUG

Bolus 1.5 mg/kg over 5 minutes, then an infusion of 2 mg/kg/h

Group L
Normal salineDRUG

Sodium Chloride 0.9% infusion

Also known as: Saline solution
Group P

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children between 2 and 12 years
  • ASA I or II
  • Programmed for elective tonsillectomy with or without adenoidectomy under general anesthesia

You may not qualify if:

  • Obesity, defined as body mass index (BMI) ≥ 95th percentile for age and sex.
  • Use of antiemetic drugs during the 24 hours before surgery.
  • Gastroesophageal reflux.
  • History of allergy to any of the drugs used in the study.
  • Down Syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

División de Anestesia - Facultad de Medicina Pontificia Universidad Católica

Santiago, Santiago Metropolitan, 8330024, Chile

Location

Related Publications (1)

  • Echevarria GC, Altermatt FR, Paredes S, Puga V, Auad H, Veloso AM, Elgueta MF. Intra-operative lidocaine in the prevention of vomiting after elective tonsillectomy in children: A randomised controlled trial. Eur J Anaesthesiol. 2018 May;35(5):343-348. doi: 10.1097/EJA.0000000000000807.

    PMID: 29570108DERIVED

MeSH Terms

Conditions

Postoperative Nausea and VomitingPainNauseaVomiting

Interventions

LidocaineSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and SymptomsNeurologic Manifestations

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Fernando R Altermatt, MD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2013

First Posted

November 18, 2013

Study Start

March 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 24, 2015

Record last verified: 2015-09

Locations

CL(1)