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

Comparison of the Effects of Oxycodone Versus Fentanyl on Airway Reflex to Tracheal Extubation and Postoperative Pain During Recovery of Anesthesia After Laparoscopic Cholecystectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03204045
Enrollment
90
Registered
2017-06-29
Start date
2017-02-01
Completion date
2017-06-05
Last updated
2017-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coughing Responses at Tracheal Extubation

Keywords

oxycodone, fentanyl, tracheal extubation

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).

Interventions

DRUGfentanyl

2 mL mixture of fentanyl with isotonic saline

DRUGOxycodone

2 mL mixture of oxycodone with isotonic saline

DRUGcontrol

isotonic saline 2 mL

Sponsors

Yeungnam University College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
airway responseat point of awareness (eye opening in response to verbal commands), extubation, and 3 min after tracheal extubationincidence of coughinging
postoperative pain5 and 30 min in the postanesthetic care unitnumerical rating scale ranging from 0 (no pain) to 10 (worst pain)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026