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

Coughing Responses at Tracheal Extubation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03204045
• Other study ID #: YUMC 2017-06-26
• Status: Completed
• Phase: N/A
• First received: June 26, 2017
• Last updated: July 5, 2017
• Start date: February 1, 2017
• Est. completion date: June 5, 2017

Study information

• Verified date: July 2017
• Source: Yeungnam University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 5, 2017
• Est. primary completion date: May 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Coughing Responses at Tracheal Extubation
• Pain, Postoperative

Intervention

Drug:
• fentanyl
2 mL mixture of fentanyl with isotonic saline
• Oxycodone
2 mL mixture of oxycodone with isotonic saline
• control
isotonic saline 2 mL

Locations

Country	Name	City	State
Korea, Republic of	Yeungnam University Hospital	Daegu	Nam-gu, Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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