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

Yeungnam University College of Medicine

Status: Completed

Conditions: Coughing Responses at Tracheal Extubation

Treatments: Drug: Oxycodone; Drug: fentanyl; Drug: control

Study type: Interventional

Funder types: Other

Identifiers

NCT03204045

YUMC 2017-06-26

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

fentanyl

Active Comparator group

Description:

fentanyl 1 ㎍/kg

Treatment:

Drug: Oxycodone

Drug: control

oxycodone

Active Comparator group

Description:

oxycodone 0.08 mg/kg

Treatment:

Drug: fentanyl

Drug: control

control

Placebo Comparator group

Description:

isotonic saline

Treatment:

Drug: fentanyl

Drug: Oxycodone