Intubation ComplicationPhase 4NCT02484352
Optimal Dose of Intravenous Oxycodone for Endotracheal Intubation
A Phase 4 study testing saline, 0.05 mg/kg of oxycodone and 0.1 mg/kg of oxycodone in people with Intubation Complication and Blood Pressure, run by Yong-Hee Park at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Intubation Complication, Blood Pressure
- What is being tested?
- saline, 0.05 mg/kg of oxycodone and 0.1 mg/kg of oxycodone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to 12 Feb 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) class 1
Who cannot join
- ASA class over 2
- expected difficult intubation
- intubation time over 30 seconds
- intubation trial was more than once
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital
Seoul
About this study
Official title: 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.
Read the 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.
- Conditions
- Intubation Complication, Blood Pressure
- Being tested
- saline, 0.05 mg/kg of oxycodone, 0.1 mg/kg of oxycodone, 0.15 mg/kg of oxycodone, 0.2 mg/kg of oxycodone
- Keywords
- dosage of oxycodone during intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salineDrug
different dosage of IV oxycodone was given before intubation
0.05 mg/kg of oxycodoneDrug
Also called OxyNorm
different dosage of IV oxycodone was given before intubation
0.1 mg/kg of oxycodoneDrug
Also called OxyNorm
different dosage of IV oxycodone was given before intubation
0.15 mg/kg of oxycodoneDrug
Also called OxyNorm
different dosage of IV oxycodone was given before intubation
0.2 mg/kg of oxycodoneDrug
Also called OxyNorm
different dosage of IV oxycodone was given before intubation
| Study group | Role | What they receive |
|---|---|---|
| 0 mg/kg of oxycodone | Other | Intervention: patients receive 10 ml of normal saline without oxycodone through intravenous route before intubation. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: 0.2 mg/kg of oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure changes before and after endotracheal intubation
highest blood pressure and baseline blood pressure
Measured: from entrance to operating room to intubation time; up to 30 minutes
Secondary outcomes (2)
total dose of vasopressor; dose x frequency
Measured: 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
Measured: from entrance to operating room to intubation time; up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completion12 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yong-Hee Park
- Sponsor type
- University, hospital or other
- Collaborators
- Chung-Ang University
- Responsible party
- Sponsor-investigator, Yong-Hee Park, Chung-Ang University Hospital
- Investigators
- Young-Cheol Woo, Ph.D., Study director, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484352
- Sponsor's protocol ID
- C2014115(1311)
- Status last verified
- Jul 2017
- First submitted
- 19 Jun 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 23314694Russell 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.
PubMed 7272146
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dose of Intravenous Oxycodone for Attenuation of Hemodynamic
- ClinicalTrials.gov ID
- NCT02484352
- Acronym / sponsor ID
- C2014115(1311)
- Conditions
- Intubation Complication, Blood Pressure
- Keywords
- dosage of oxycodone during intubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Yong-Hee ParkUniversity, hospital or other
- Collaborators
- Chung-Ang University
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- 12 Feb 2017 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0 mg/kg of oxycodone | Other | Drug: salineIntervention: patients receive 10 ml of normal saline without oxycodone through intravenous route before intubation. |
| 0.05 mg/kg of oxycodone | Other | Drug: 0.05 mg/kg of oxycodoneIntervention: patients receive 10 ml of fluid with 0.05 mg/kg of oxycodone in normal saline through intravenous route before intubation. |
| 0.1 mg/kg of oxycodone | Other | Drug: 0.1 mg/kg of oxycodoneIntervention: patients receive 10 ml of fluid with 0.1 mg/kg of oxycodone in normal saline through intravenous route before intubation. |
| 0.15 mg/kg of oxycodone | Other | Drug: 0.15 mg/kg of oxycodoneIntervention: patients receive 10 ml of fluid with 0.15 mg/kg of oxycodone in normal saline through intravenous route before intubation. |
| 0.2 mg/kg of oxycodone | Other | Drug: 0.2 mg/kg of oxycodoneIntervention: patients receive 10 ml of fluid with 0.2 mg/kg of oxycodone in normal saline through intravenous route before intubation. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) class 1
Key exclusion criteria (4 listed)
- ASA class over 2
- expected difficult intubation
- intubation time over 30 seconds
- intubation trial was more than once
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salinedifferent dosage of IV oxycodone was given before intubation | Drug | 0 mg/kg of oxycodone |
| 0.05 mg/kg of oxycodoneAlso: OxyNormdifferent dosage of IV oxycodone was given before intubation | Drug | 0.05 mg/kg of oxycodone |
| 0.1 mg/kg of oxycodoneAlso: OxyNormdifferent dosage of IV oxycodone was given before intubation | Drug | 0.1 mg/kg of oxycodone |
| 0.15 mg/kg of oxycodoneAlso: OxyNormdifferent dosage of IV oxycodone was given before intubation | Drug | 0.15 mg/kg of oxycodone |
| 0.2 mg/kg of oxycodoneAlso: OxyNormdifferent dosage of IV oxycodone was given before intubation | Drug | 0.2 mg/kg of oxycodone |
Primary outcome
blood pressure changes before and after endotracheal intubation
Time frame: from entrance to operating room to intubation time; up to 30 minutes
highest blood pressure and baseline blood pressure
2 secondary outcomes
total dose of vasopressor; dose x frequency
Time frame: during the induction phase of anesthesia before surgical incision up to 30 minutes
heart rate changes before and after endotracheal intubation
Time frame: from entrance to operating room to intubation time; up to 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Background: PubMed 23314694Sawano 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.
- Background: PubMed 7272146Russell 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Cheol Woo, Ph.D. study director
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing saline, 0.05 mg/kg of oxycodone and 0.1 mg/kg of oxycodone in people with Intubation Complication and Blood Pressure, run by Yong-Hee Park at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure changes before and after endotracheal intubation (time frame: from entrance to operating room to intubation time; up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484352, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.