Optimal Dose of Intravenous Oxycodone for Endotracheal Intubation

Blood Pressure Clinical Trial

Official title:

Optimal Dose of Intravenous Oxycodone for Attenuation of Hemodynamic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484352
• Other study ID #: C2014115(1311)
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2015
• Last updated: July 18, 2017
• Start date: July 2015
• Est. completion date: February 12, 2017

Study information

• Verified date: July 2017
• Source: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: February 12, 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Intubation Complication

Intervention

Drug:
• saline
different dosage of IV oxycodone was given before intubation
• 0.05 mg/kg of oxycodone
different dosage of IV oxycodone was given before intubation
• 0.1 mg/kg of oxycodone
different dosage of IV oxycodone was given before intubation
• 0.15 mg/kg of oxycodone
different dosage of IV oxycodone was given before intubation
• 0.2 mg/kg of oxycodone
different dosage of IV oxycodone was given before intubation

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Yong-Hee Park	Chung-Ang University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	total dose of vasopressor; dose x frequency		during the induction phase of anesthesia before surgical incision up to 30 minutes
Secondary	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