Optimal Dose of Intravenous Oxycodone for Endotracheal Intubation
NCT ID: NCT02484352
Last Updated: 2017-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
95 participants
INTERVENTIONAL
2015-07-31
2017-02-12
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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0 mg/kg of oxycodone
Intervention: patients receive 10 ml of normal saline without oxycodone through intravenous route before intubation.
saline
different dosage of IV oxycodone was given before intubation
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.
0.05 mg/kg of oxycodone
different dosage of IV oxycodone was given before intubation
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.
0.1 mg/kg of oxycodone
different dosage of IV oxycodone was given before intubation
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.
0.15 mg/kg of oxycodone
different dosage of IV oxycodone was given before intubation
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.
0.2 mg/kg of oxycodone
different dosage of IV oxycodone was given before intubation
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* expected difficult intubation
* intubation time over 30 seconds
* intubation trial was more than once
20 Years
65 Years
ALL
No
Sponsors
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Chung-Ang University
OTHER
Yong-Hee Park
OTHER
Responsible Party
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Yong-Hee Park
Assistant professor
Principal Investigators
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Young-Cheol Woo, Ph.D.
Role: STUDY_DIRECTOR
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Locations
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Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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C2014115(1311)
Identifier Type: -
Identifier Source: org_study_id
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