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

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ClinicalTrials.gov Identifier: NCT03204045
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Sangjin Park, 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.

Condition or disease Intervention/treatment Phase
Coughing Responses at Tracheal Extubation Drug: fentanyl Drug: Oxycodone Drug: control Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : May 5, 2017
Actual Study Completion Date : June 5, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: fentanyl
fentanyl 1 ㎍/kg
Drug: Oxycodone
2 mL mixture of oxycodone with isotonic saline

Drug: control
isotonic saline 2 mL

Active Comparator: oxycodone
oxycodone 0.08 mg/kg
Drug: fentanyl
2 mL mixture of fentanyl with isotonic saline

Drug: control
isotonic saline 2 mL

Placebo Comparator: control
isotonic saline
Drug: fentanyl
2 mL mixture of fentanyl with isotonic saline

Drug: Oxycodone
2 mL mixture of oxycodone with isotonic saline




Primary Outcome Measures :
  1. airway response [ Time Frame: at point of awareness (eye opening in response to verbal commands), extubation, and 3 min after tracheal extubation ]
    incidence of coughinging

  2. postoperative pain [ Time Frame: 5 and 30 min in the postanesthetic care unit ]
    numerical rating scale ranging from 0 (no pain) to 10 (worst pain)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204045


Locations
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Korea, Republic of
Yeungnam University Hospital
Daegu, Nam-gu, Daegu, Korea, Republic of, 42415
Sponsors and Collaborators
Yeungnam University College of Medicine

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Responsible Party: Sangjin Park, Professor, Yeungnam University College of Medicine
ClinicalTrials.gov Identifier: NCT03204045     History of Changes
Other Study ID Numbers: YUMC 2017-06-26
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sangjin Park, Yeungnam University College of Medicine:
oxycodone, fentanyl, tracheal extubation

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics