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Optimal Dose of Intravenous Oxycodone for Endotracheal Intubation

Optimal Dose of Intravenous Oxycodone for Attenuation of Hemodynamic

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02484352
Enrollment
95
Registered
2015-06-29
Start date
2015-07-31
Completion date
2017-02-12
Last updated
2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Intubation Complication

Keywords

dosage of oxycodone during intubation

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.

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.

Interventions

DRUGsaline

different dosage of IV oxycodone was given before intubation

DRUG0.05 mg/kg of oxycodone

different dosage of IV oxycodone was given before intubation

DRUG0.1 mg/kg of oxycodone

different dosage of IV oxycodone was given before intubation

DRUG0.15 mg/kg of oxycodone

different dosage of IV oxycodone was given before intubation

DRUG0.2 mg/kg of oxycodone

different dosage of IV oxycodone was given before intubation

Sponsors

Chung-Ang University
CollaboratorOTHER
Yong-Hee Park
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
blood pressure changes before and after endotracheal intubationfrom entrance to operating room to intubation time; up to 30 minuteshighest blood pressure and baseline blood pressure

Secondary

MeasureTime frameDescription
total dose of vasopressor; dose x frequencyduring the induction phase of anesthesia before surgical incision up to 30 minutes
heart rate changes before and after endotracheal intubationfrom entrance to operating room to intubation time; up to 30 minuteshighest heart rate and baseline heart rate

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026