Optimal Dose of Intravenous Oxycodone for Endotracheal Intubation

Optimal Dose of Intravenous Oxycodone for Attenuation of Hemodynamic

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Intubation Complication
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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 Names: OxyNorm
Other: 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 Names: OxyNorm
Other: 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 Names: OxyNorm
Other: 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 Names: OxyNorm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure changes before and after endotracheal intubation	highest blood pressure and baseline blood pressure	from entrance to operating room to intubation time; up to 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total dose of vasopressor; dose x frequency		during the induction phase of anesthesia before surgical incision up to 30 minutes
heart rate changes before and after endotracheal intubation	highest heart rate and baseline heart rate	from entrance to operating room to intubation time; up to 30 minutes

Collaborators and Investigators

• Sponsor: Yong-Hee Park
• Collaborators: Chung-Ang University
• Investigators: Study Director: Young-Cheol Woo, Ph.D., Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Publications and helpful links

General Publications

• Sawano Y, Miyazaki M, Shimada H, Kadoi Y. Optimal fentanyl dosage for attenuating systemic hemodynamic changes, hormone release and cardiac output changes during the induction of anesthesia in patients with and without hypertension: a prospective, randomized, double-blinded study. J Anesth. 2013 Aug;27(4):505-11. doi: 10.1007/s00540-012-1552-x. Epub 2013 Jan 12.
• Russell WJ, Morris RG, Frewin DB, Drew SE. Changes in plasma catecholamine concentrations during endotracheal intubation. Br J Anaesth. 1981 Aug;53(8):837-9. doi: 10.1093/bja/53.8.837.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): February 12, 2017

Study Registration Dates

• First Submitted: June 19, 2015
• First Submitted That Met QC Criteria: June 24, 2015
• First Posted (Estimate): June 29, 2015

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: dosage of oxycodone during intubation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: C2014115(1311)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided