Intubation, IntratrachealNCT03728686
Response to Endotracheal Tube Intubation at Different Time of Fentanyl Given During Induction
A study testing Different given time in people with Intubation, Intratracheal, run by Chien-Chung,Huang at 1 site in Taiwan.
Trial summary
Opioids have been used to modify the hemodynamic response associated with laryngoscopy and tracheal intubation. To seek the correlation of Fentanyl given time, we will analysis the data collected from vital signs monitoring machine. Patients'details will be recorded too. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- Different given time
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Dec 2016to 30 Jul 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- with American Society of Anesthesiologists (ASA) physical status classification 1\&2
- undergo elective surgery
- intubation
Who cannot join
- Opioids allergy history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Hemodynamic Response to Endotracheal Intubation at Different Time of Fentanyl Given During Induction: a Randomized Controlled Trial
Opioids have been used to modify the hemodynamic response associated with laryngoscopy and tracheal intubation. To seek the correlation of Fentanyl given time, we will analysis the data collected from vital signs monitoring machine. Patients'details will be recorded too.
Read the detailed description
Laryngoscopy and intubation often provoke hypertension and tachycardia due to the stimulation both sympathetic and sympathoadrenal activities. While the adverse hemodynamic effects of laryngoscopy and endotracheal intubation can precipitate myocardial ischemia, even in patients without hypertension, the responses are exaggerated in patients with hypertension . In the previous studies , many drugs, including opioids and beta-blockers, have been used to modify the hemodynamic response associated with laryngoscopy and tracheal intubation. To seek the correlation of Fentanyl given time, we will analysis the data collected from vital signs monitoring machine.
All patients were premedicated with Midazolam 0.1mg/kg , Lidocaine 0.5mg/kg (L), Propofol 2mg/kg (P), Rocuronium 1mg/kg (R) before induction of general anesthesia. Laryngoscopy lasting a maximum of 30 s was attempted 3 min after administration of the induction agents. Fentanyl 2mcg/kg was given at different time before intubation.
- Conditions
- Intubation, Intratracheal
- Being tested
- Different given time
- Keywords
- Intubation, Intratracheal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different given timeOther
Fentanyl 2mcg/kg (F) was given at either 1,2,3 minutes before intubation
| Study group | Role | What they receive |
|---|---|---|
| 3mins | Experimental | Different given time: Fentanyl 2mcg/kg was given at either time 3 minutes before intubation Receives: Other: Different given time |
| 2mins | Active comparator | Different given time: Fentanyl 2mcg/kg was given at either time 2 minutes before intubation Receives: Other: Different given time |
| control | No intervention | Different given time: Fentanyl 2mcg/kg was given at either time 1 minute before intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
heart rate
Measured: 0-10 minutes during induction
systolic blood pressure
systolic blood pressure
Measured: 0-10 minutes during induction
diastolic blood pressure
diastolic blood pressure
Measured: 0-10 minutes during induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start16 Dec 2016
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intubation, IntratrachealStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chien-Chung,Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chien-Chung,Huang, Mackay Memorial Hospital
- Investigators
- Chicn-Chung Huang, MD, Study director, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728686
- Sponsor's protocol ID
- 16MMHIS097e
- Status last verified
- Nov 2018
- First submitted
- 31 Oct 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parida S, Ashraf NC, Mathew JS, Mishra SK, Badhe AS. Attenuation of the haemodynamic responses to tracheal intubation with gabapentin, fentanyl and a combination of both: A randomised controlled trial. Indian J Anaesth. 2015 May;59(5):306-11. doi: 10.4103/0019-5049.156885.
PubMed 26019356Sawano 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 23314694Derbyshire DR, Chmielewski A, Fell D, Vater M, Achola K, Smith G. Plasma catecholamine responses to tracheal intubation. Br J Anaesth. 1983 Sep;55(9):855-60. doi: 10.1093/bja/55.9.855.
PubMed 6615672Shribman AJ, Smith G, Achola KJ. Cardiovascular and catecholamine responses to laryngoscopy with and without tracheal intubation. Br J Anaesth. 1987 Mar;59(3):295-9. doi: 10.1093/bja/59.3.295.
PubMed 3828177Martin DE, Rosenberg H, Aukburg SJ, Bartkowski RR, Edwards MW Jr, Greenhow DE, Klineberg PL. Low-dose fentanyl blunts circulatory responses to tracheal intubation. Anesth Analg. 1982 Aug;61(8):680-4.
PubMed 7201271
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hemodynamic Response to Endotracheal Intubation at Different Time of Fentanyl Given During Induction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03728686
- Acronym / sponsor ID
- 16MMHIS097e
- Conditions
- Intubation, Intratracheal
- Keywords
- Intubation, Intratracheal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Chien-Chung,HuangUniversity, hospital or other
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 2 Nov 2018 (actual)
- 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.
Opioids have been used to modify the hemodynamic response associated with laryngoscopy and tracheal intubation. To seek the correlation of Fentanyl given time, we will analysis the data collected from vital signs monitoring machine. Patients'details will be recorded too.
Detailed description
Laryngoscopy and intubation often provoke hypertension and tachycardia due to the stimulation both sympathetic and sympathoadrenal activities. While the adverse hemodynamic effects of laryngoscopy and endotracheal intubation can precipitate myocardial ischemia, even in patients without hypertension, the responses are exaggerated in patients with hypertension . In the previous studies , many drugs, including opioids and beta-blockers, have been used to modify the hemodynamic response associated with laryngoscopy and tracheal intubation. To seek the correlation of Fentanyl given time, we will analysis the data collected from vital signs monitoring machine.
All patients were premedicated with Midazolam 0.1mg/kg , Lidocaine 0.5mg/kg (L), Propofol 2mg/kg (P), Rocuronium 1mg/kg (R) before induction of general anesthesia. Laryngoscopy lasting a maximum of 30 s was attempted 3 min after administration of the induction agents. Fentanyl 2mcg/kg was given at different time before intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3mins | Experimental | Other: Different given timeDifferent given time: Fentanyl 2mcg/kg was given at either time 3 minutes before intubation |
| 2mins | Active comparator | Other: Different given timeDifferent given time: Fentanyl 2mcg/kg was given at either time 2 minutes before intubation |
| control | No intervention | –Different given time: Fentanyl 2mcg/kg was given at either time 1 minute before intubation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- with American Society of Anesthesiologists (ASA) physical status classification 1\&2
- undergo elective surgery
- intubation
Key exclusion criteria (1 listed)
- Opioids allergy history
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 |
|---|---|---|
| Different given timeFentanyl 2mcg/kg (F) was given at either 1,2,3 minutes before intubation | Other | 2mins, 3mins |
Primary outcome
heart rate
Time frame: 0-10 minutes during induction
heart rate
systolic blood pressure
Time frame: 0-10 minutes during induction
systolic blood pressure
diastolic blood pressure
Time frame: 0-10 minutes during induction
diastolic blood pressure
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 6 Nov 2018.
- Background: PubMed 26019356Parida S, Ashraf NC, Mathew JS, Mishra SK, Badhe AS. Attenuation of the haemodynamic responses to tracheal intubation with gabapentin, fentanyl and a combination of both: A randomised controlled trial. Indian J Anaesth. 2015 May;59(5):306-11. doi: 10.4103/0019-5049.156885.
- 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 6615672Derbyshire DR, Chmielewski A, Fell D, Vater M, Achola K, Smith G. Plasma catecholamine responses to tracheal intubation. Br J Anaesth. 1983 Sep;55(9):855-60. doi: 10.1093/bja/55.9.855.
- Background: PubMed 3828177Shribman AJ, Smith G, Achola KJ. Cardiovascular and catecholamine responses to laryngoscopy with and without tracheal intubation. Br J Anaesth. 1987 Mar;59(3):295-9. doi: 10.1093/bja/59.3.295.
- Background: PubMed 7201271Martin DE, Rosenberg H, Aukburg SJ, Bartkowski RR, Edwards MW Jr, Greenhow DE, Klineberg PL. Low-dose fentanyl blunts circulatory responses to tracheal intubation. Anesth Analg. 1982 Aug;61(8):680-4.
- Individual participant dataSharing planned: No
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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.
Chicn-Chung Huang, MD study director
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different given time in people with Intubation, Intratracheal, run by Chien-Chung,Huang at 1 site in Taiwan.
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 3 inclusion and 1 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 6 Nov 2018. 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 Taiwan. 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.
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?
heart rate (time frame: 0-10 minutes during induction). The study lists 3 primary outcomes in all. 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 NCT03728686, which also lists 5 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 6 Nov 2018.