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

Not Applicable

Completed

• Conditions: Coughing Responses at Tracheal Extubation
• Interventions: Drug: fentanyl; Drug: Oxycodone; Drug: control

• Registration Number: NCT03204045
• Lead Sponsor: Yeungnam University College of Medicine

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).

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2017-05-05
• Study Completion: 2017-06-05
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-29
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	fentanyl	isotonic saline
fentanyl	Oxycodone	fentanyl 1 ㎍/kg
fentanyl	control	fentanyl 1 ㎍/kg
oxycodone	control	oxycodone 0.08 mg/kg
oxycodone	fentanyl	oxycodone 0.08 mg/kg
control	Oxycodone	isotonic saline

Primary Outcome Measures

Name	Time	Method
airway response	at point of awareness (eye opening in response to verbal commands), extubation, and 3 min after tracheal extubation	incidence of coughinging
postoperative pain	5 and 30 min in the postanesthetic care unit	numerical rating scale ranging from 0 (no pain) to 10 (worst pain)

Trial Locations

Locations (1)

Yeungnam University Hospital; 🇰🇷 Daegu, Nam-gu, Daegu, Korea, Republic of