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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2017-06-05

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Coughing Responses at Tracheal Extubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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fentanyl

fentanyl 1 ㎍/kg

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

2 mL mixture of oxycodone with isotonic saline

control

Intervention Type DRUG

isotonic saline 2 mL

oxycodone

oxycodone 0.08 mg/kg

Group Type ACTIVE_COMPARATOR

fentanyl

Intervention Type DRUG

2 mL mixture of fentanyl with isotonic saline

control

Intervention Type DRUG

isotonic saline 2 mL

control

isotonic saline

Group Type PLACEBO_COMPARATOR

fentanyl

Intervention Type DRUG

2 mL mixture of fentanyl with isotonic saline

Oxycodone

Intervention Type DRUG

2 mL mixture of oxycodone with isotonic saline

Interventions

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fentanyl

2 mL mixture of fentanyl with isotonic saline

Intervention Type DRUG

Oxycodone

2 mL mixture of oxycodone with isotonic saline

Intervention Type DRUG

control

isotonic saline 2 mL

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No