NCT02150161

Brief Summary

The purpose of this study is to determine whether an infusion of lidocaine/ketamine compared to fentanyl is equivalent in anesthesia effectiveness and can help reduce the incidence of postoperative nausea and vomiting in patients undergoing elective hip arthroscopy surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
53

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

May 26, 2014

Last Update Submit

September 24, 2015

Conditions

Opioid Free AnaesthesiaPostoperative Analgesia

Outcome Measures

Primary Outcomes (2)

  • Incidence of postoperative nausea and vomiting in the recovery room

    first 3 postoperative hours

  • morphine consumption in the recovery room

    first 3 postopeartive hours

Secondary Outcomes (2)

  • Incidence of postoperative nausea and vomiting on day 1

    1st postoperative day

  • Anesthestic gas consumption

    intraoperative

Study Arms (2)

lidocaine/ ketamine infusion

EXPERIMENTAL

lidocaine 1mg/Kg bolus, followed by continuous infusion 1 mg/kg/h AND ketamine 1mg/Kg bolus followed by continuous infusion 1 mg/kg/h

Drug: Lidocaine/ ketamine

fentanyl

ACTIVE COMPARATOR

iv fentanyl, 3ug/kg bolus

Drug: Fentanyl

Interventions

Lidocaine/ ketamineDRUG
lidocaine/ ketamine infusion
FentanylDRUG
fentanyl

Eligibility Criteria

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

You may qualify if:

  • years old
  • ASA I-II
  • Undergoing elective hip arthroscopy

You may not qualify if:

  • Known allergies to study drugs
  • Opioid use 1 month prior to surgery
  • BMI \>30
  • Unable to comprehend visual analog scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Santa Maria

Santiago, Chile

Location

MeSH Terms

Interventions

LidocaineKetamineFentanyl

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • David Torres, MD; MSc

    Clinica Santa Maria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 26, 2014

First Posted

May 29, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

CL(1)