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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started Jul 2015

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.6 years study duration

First Submitted

Initial submission to the registry

June 19, 2015

Completed

10 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed

2 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2017

Completed

Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

June 19, 2015

Last Update Submit

July 18, 2017

Conditions

Intubation Complication Blood Pressure

Keywords

dosage of oxycodone during intubation

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

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
from entrance to operating room to intubation time; up to 30 minutes

Study Arms (5)

0 mg/kg of oxycodone

OTHER

Intervention: patients receive 10 ml of normal saline without oxycodone through intravenous route before intubation.

Drug: saline

0.05 mg/kg of oxycodone

OTHER

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

0.1 mg/kg of oxycodone

OTHER

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

0.15 mg/kg of oxycodone

OTHER

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

0.2 mg/kg of oxycodone

OTHER

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