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Optimal Dose of Intravenous Oxycodone for Endotracheal Intubation

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ClinicalTrials.gov Identifier: NCT02484352
Recruitment Status : Completed
First Posted : June 29, 2015
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Chung-Ang University
Information provided by (Responsible Party):
Yong-Hee Park, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Brief Summary:

Intravenous form of oxycodone is recently used for the adjunct of anesthetic agents to avoid adverse effects of the stimulation of endotracheal intubation. The potency ratio of oxycodone to fentanyl is not absolutely defined. The aim of this study was to assess the optimal dose of intravenous oxycodone for attenuation of hemodynamic responses to laryngoscopy and endotracheal intubation.

A prospective, randomized, double-blind study was conducted. Ninety one patients were randomly divided into 5 group based on the dose of oxycodone; 0, 0.05, 0.1, 0.15, 0.2 mg/kg. After giving each assigned dose of intravenous oxycodone, anesthesia was induced with thiopental and rocuronium. Heart rate (HR) and blood pressure (BP) was collected at baseline, before intubation, 1, 2, 3 minutes after intubation. The change of BP was calculated by (highest BP after intubation - baseline BP)/baseline BP.


Condition or disease Intervention/treatment Phase
Intubation Complication Blood Pressure Drug: saline Drug: 0.05 mg/kg of oxycodone Drug: 0.1 mg/kg of oxycodone Drug: 0.15 mg/kg of oxycodone Drug: 0.2 mg/kg of oxycodone Phase 4

Detailed Description:

Endotracheal intubation is almost always associated with increase of catecholamine and arterial blood pressure. To prevent the responses to laryngoscopy and tracheal intubation, adjuvant use of opioid to sedative drugs during anesthetic induction phase are common. Intravenous form of oxycodone is recently used for the adjunct of anesthetic agents to avoid adverse effects of the stimulation of endotracheal intubation. However, The potency ratio of oxycodone to fentanyl is not absolutely defined. Therefore, the investigators aimed to assess the optimal dose of intravenous oxycodone for attenuation of hemodynamic responses to laryngoscopy and endotracheal intubation.

The patients were randomly divided into five different groups based on the dose of oxycodone; 0. 0.05, 0.1, 0.15, 0.2 mg/kg. The drug was prepared by a person who is not participating the anesthetic management and surgery of the patient. In five groups, the drug was mixed with normal saline which makes the total drug volume to be 10 ml. After monitoring was started including ECG, noninvasive blood pressure, and pulse oximetry, the anesthesiologist who has no information about the drug give the drug when starting induction of anesthesia. Thiopental 4-5 mg/kg and rocuronium 0.6-0.9 mg/kg was given subsequently. Manual ventilation was done with sevoflurane 3-5 volume% for 2-3 minutes and tracheal intubation was done. Maintenance of anesthesia was done with 50% O2 with nitrous oxide and sevoflurane. Mechanical ventilation was done with tidal volume 10 ml/kg and respiratory rate 12 /min. The baseline hemodynamic data including heart rate and blood pressure was recorded and those before intubation, 1,2,3 minutes after intubation were obtained. The discrepancies between the highest and baseline, the lowest blood pressure and heart rate and baseline were used to make out the proportion of hemodynamic changes. This proportion of the hemodynamic changes were compared in five groups. In addition, the use of vasopressor was also recorded and the frequency and the cumulative dose was compared among the groups.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Dose of Intravenous Oxycodone for Attenuation of Hemodynamic
Study Start Date : July 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : February 12, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
0 mg/kg of oxycodone
Intervention: patients receive 10 ml of normal saline without oxycodone through intravenous route before intubation.
Drug: saline
different dosage of IV oxycodone was given before intubation

0.05 mg/kg of oxycodone
Intervention: patients receive 10 ml of fluid with 0.05 mg/kg of oxycodone in normal saline through intravenous route before intubation.
Drug: 0.05 mg/kg of oxycodone
different dosage of IV oxycodone was given before intubation
Other Name: OxyNorm

0.1 mg/kg of oxycodone
Intervention: patients receive 10 ml of fluid with 0.1 mg/kg of oxycodone in normal saline through intravenous route before intubation.
Drug: 0.1 mg/kg of oxycodone
different dosage of IV oxycodone was given before intubation
Other Name: OxyNorm

0.15 mg/kg of oxycodone
Intervention: patients receive 10 ml of fluid with 0.15 mg/kg of oxycodone in normal saline through intravenous route before intubation.
Drug: 0.15 mg/kg of oxycodone
different dosage of IV oxycodone was given before intubation
Other Name: OxyNorm

0.2 mg/kg of oxycodone
Intervention: patients receive 10 ml of fluid with 0.2 mg/kg of oxycodone in normal saline through intravenous route before intubation.
Drug: 0.2 mg/kg of oxycodone
different dosage of IV oxycodone was given before intubation
Other Name: OxyNorm




Primary Outcome Measures :
  1. blood pressure changes before and after endotracheal intubation [ Time Frame: from entrance to operating room to intubation time; up to 30 minutes ]
    highest blood pressure and baseline blood pressure


Secondary Outcome Measures :
  1. total dose of vasopressor; dose x frequency [ Time Frame: during the induction phase of anesthesia before surgical incision up to 30 minutes ]
  2. heart rate changes before and after endotracheal intubation [ Time Frame: from entrance to operating room to intubation time; up to 30 minutes ]
    highest heart rate and baseline heart rate



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) class 1

Exclusion Criteria:

  • ASA class over 2
  • expected difficult intubation
  • intubation time over 30 seconds
  • intubation trial was more than once

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): NCT02484352


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yong-Hee Park
Chung-Ang University
Investigators
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Study Director: Young-Cheol Woo, Ph.D. Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Publications:
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Responsible Party: Yong-Hee Park, Assistant professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
ClinicalTrials.gov Identifier: NCT02484352     History of Changes
Other Study ID Numbers: C2014115(1311)
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yong-Hee Park, Chung-Ang University Hosptial, Chung-Ang University College of Medicine:
dosage of oxycodone during intubation

Additional relevant MeSH terms:
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Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents