Clinical trial NCT03204045: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coughing Responses at Tracheal Extubation
Keywords: oxycodone, fentanyl, tracheal extubation
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: airway response
timeFrame: at point of awareness (eye opening in response to verbal commands), extubation, and 3 min after tracheal extubation
measure: postoperative pain
timeFrame: 5 and 30 min in the postanesthetic care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
state: Nam-gu, Daegu
Study officials:
References: