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Comparison of the Effects of Oxycodone Versus Fentanyl on Airway Reflex to Tracheal Extubation and Postoperative Pain

Primary Purpose

Coughing Responses at Tracheal Extubation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fentanyl
Oxycodone
control
Sponsored by
Yeungnam University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coughing Responses at Tracheal Extubation focused on measuring oxycodone, fentanyl, tracheal extubation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Yeungnam University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

fentanyl

oxycodone

control

Arm Description

fentanyl 1 ㎍/kg

oxycodone 0.08 mg/kg

isotonic saline

Outcomes

Primary Outcome Measures

airway response
incidence of coughinging
postoperative pain
numerical rating scale ranging from 0 (no pain) to 10 (worst pain)

Secondary Outcome Measures

Full Information

First Posted
June 26, 2017
Last Updated
July 5, 2017
Sponsor
Yeungnam University College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03204045
Brief Title
Comparison of the Effects of Oxycodone Versus Fentanyl on Airway Reflex to Tracheal Extubation and Postoperative Pain
Official Title
Comparison of the Effects of Oxycodone Versus Fentanyl on Airway Reflex to Tracheal Extubation and Postoperative Pain During Recovery of Anesthesia After Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
May 5, 2017 (Actual)
Study Completion Date
June 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study was approved by the committee of Institutional Review Board of the Yeungnam University Hospital, Daegu, Republic of Korea. 90 patients were enrolled in this study and written informed consent was obtained from all patients. We included patients with ASA physical status classification I or II, and aged 18-65 years scheduled for elective laparoscopic cholecystectomy. Patients were assigned to one of three groups by computer-generated randomization, fentanyl group (group F, N=30), oxydodone group (group O, N=30), or control group (group C, N=30). 10 minutes before completion of surgery, patients received 2 mL mixture of fentanyl 1 ㎍/kg or oxycodone 0.08 mg/kg with isotonic saline or isotonic saline 2 mL intravenously in accordance with allocated study groups by an anesthesiologist who was blinded to group treatment. Airway reflex responses including coughing, breath holding, bucking, and laryngospasm were recorded at point of awareness, extubation, and 3 min after tracheal extubation. Hemodynamic responses were recorded at the completion of surgery (T1), at the point of awareness (T2), at the point of extubation (T3), and 3 min after tracheal extubation (T4). Coughing severity was assessed using a 5-point scale. In the recovery room, hemodynamic responses were evaluated every 5 min for 30 min. The postoperative pain intensity was assessed 5 and 30 min in the postanesthetic care unit (PACU) using numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coughing Responses at Tracheal Extubation
Keywords
oxycodone, fentanyl, tracheal extubation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fentanyl
Arm Type
Active Comparator
Arm Description
fentanyl 1 ㎍/kg
Arm Title
oxycodone
Arm Type
Active Comparator
Arm Description
oxycodone 0.08 mg/kg
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
isotonic saline
Intervention Type
Drug
Intervention Name(s)
fentanyl
Intervention Description
2 mL mixture of fentanyl with isotonic saline
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
2 mL mixture of oxycodone with isotonic saline
Intervention Type
Drug
Intervention Name(s)
control
Intervention Description
isotonic saline 2 mL
Primary Outcome Measure Information:
Title
airway response
Description
incidence of coughinging
Time Frame
at point of awareness (eye opening in response to verbal commands), extubation, and 3 min after tracheal extubation
Title
postoperative pain
Description
numerical rating scale ranging from 0 (no pain) to 10 (worst pain)
Time Frame
5 and 30 min in the postanesthetic care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status classification I or II, and aged 18-65 years scheduled for elective laparoscopic cholecystectomy Exclusion Criteria: 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
Facility Information:
Facility Name
Yeungnam University Hospital
City
Daegu
State/Province
Nam-gu, Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Comparison of the Effects of Oxycodone Versus Fentanyl on Airway Reflex to Tracheal Extubation and Postoperative Pain

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