NCT03204045

Brief Summary

This study was performed to compare the effects of oxycodone and fentanyl on airway and hemodynamic responses and postoperative pain during recovery period in patients undergoing laparoscopic cholecystectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

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

February 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

June 26, 2017

Last Update Submit

July 5, 2017

Conditions

Coughing Responses at Tracheal Extubation

Keywords

oxycodone, fentanyl, tracheal extubation

Outcome Measures

Primary Outcomes (2)

  • airway response

    incidence of coughinging

    at point of awareness (eye opening in response to verbal commands), extubation, and 3 min after tracheal extubation

  • postoperative pain

    numerical rating scale ranging from 0 (no pain) to 10 (worst pain)

    5 and 30 min in the postanesthetic care unit

Study Arms (3)

fentanyl

ACTIVE COMPARATOR

fentanyl 1 ㎍/kg

Drug: OxycodoneDrug: control

oxycodone

ACTIVE COMPARATOR

oxycodone 0.08 mg/kg

Drug: fentanylDrug: control

control

PLACEBO COMPARATOR

isotonic saline

Drug: fentanylDrug: Oxycodone

Interventions

fentanylDRUG

2 mL mixture of fentanyl with isotonic saline

controloxycodone
OxycodoneDRUG

2 mL mixture of oxycodone with isotonic saline

controlfentanyl
controlDRUG

isotonic saline 2 mL

fentanyloxycodone

Eligibility Criteria

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

You may qualify if:

  • ASA physical status classification I or II, and aged 18-65 years scheduled for elective laparoscopic cholecystectomy

You may not qualify if:

  • allergy to either fentanyl or oxycodone, history of chronic other opioids or analgesics use, history of cardiac, hepatic, or renal disease, other comorbid conditions, cognitive impairment or body mass index more than 35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeungnam University Hospital

Daegu, Nam-gu, Daegu, 42415, South Korea

Location

MeSH Terms

Interventions

FentanylOxycodone

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2017

First Posted

June 29, 2017

Study Start

February 1, 2017

Primary Completion

May 5, 2017

Study Completion

June 5, 2017

Last Updated

July 11, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share

Locations

KR(1)