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Completed

NCT Number: NCT02484352

Optimal Dose of Intravenous Oxycodone for Endotracheal Intubation

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline

Drug

different dosage of IV oxycodone was given before intubation

0.05 mg/kg of oxycodone

Drug

different dosage of IV oxycodone was given before intubation

Other names: OxyNorm

0.1 mg/kg of oxycodone

Drug

different dosage of IV oxycodone was given before intubation

Other names: OxyNorm

0.15 mg/kg of oxycodone

Drug

different dosage of IV oxycodone was given before intubation

Other names: OxyNorm

0.2 mg/kg of oxycodone

Drug

different dosage of IV oxycodone was given before intubation

Other names: OxyNorm

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yong-Hee Park

Other

Collaborators

  • Chung-Ang University

Registry information

Official study title

Optimal Dose of Intravenous Oxycodone for Attenuation of Hemodynamic

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
Jun 29, 2015
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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