Fentanyl-induced CoughingNCT01532466
The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing
A study testing Rocuronium in people with Fentanyl-induced Coughing, run by Taichung Armed Forces General Hospital at 1 site in Taiwan.
Trial summary
An intravenous bolus of fentanyl often induces a cough reflex. This study investigates whether priming with rocuronium can attenuate fentanyl-induced coughing effectively. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fentanyl-induced Coughing
- What is being tested?
- Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2011to Nov 2011
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 260 ASA I-II patients,
- aged between 18 and 80 years, and undergoing various elective surgeries at Taichung Armed Forces General Hospital.
Who cannot join
- a history of asthma,
- chronic cough,
- smoking,
- upper respiratory tract infection in the previous 2 weeks, and
- medication containing angiotensin-converting enzyme inhibitors or anesthetic premedication.
Trial locations and contacts
1 site in 1 country.
About this study
An intravenous bolus of fentanyl often induces a cough reflex. This study investigates whether priming with rocuronium can attenuate fentanyl-induced coughing effectively.
Read the detailed description
Fentanyl is widely used for analgesia and anesthesia because of its rapid onset, its intense analgesic effect, and is associated with lessened cardiovascular depression and low histamine release. Although the cough reflex is usually transient and self-limiting, it should be avoided in situations such as elevated intracranial, intraocular, or intra-abdominal pressure, and unstable hemodynamics.
The cause of FIC is unclear. One hypothesis is that vocal cord spasms might induce coughing because of fentanyl-induced muscle rigidity and histamine release. Muscle relaxants are commonly used to treat this condition. This study hypothesizes that priming muscle relaxants could prevent or suppress FIC. This study investigates whether the muscle relaxant rocuronium attenuates FIC effectively.
- Conditions
- Fentanyl-induced Coughing
- Being tested
- Rocuronium
- Keywords
- fentanyl-induced coughing, rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
All patients were given oxygen via a face mask. The patients were then administered with the following medications intravenously: the rocuronium group received rocuronium 0.06 mg kg-1, and the control group received the same volume of normal saline 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s).
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium, fentanyl-induced cough, normal saline | Experimental | All patients were given oxygen via a face mask. The patients were then administered with the following medications intravenously: the rocuronium group received rocuronium 0.06 mg kg-1 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s). Receives: Drug: Rocuronium |
| Normal saline | No intervention | All patients were given oxygen via a face mask. The patients were then administered with the following medications intravenously: the control group received the same volume of normal saline 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of fentanyl-induced coughing
Following the fentanyl injection, another anesthetist who was blind to the pretreatment recorded the number of coughs for 1 min. The severity of coughing was graded as mild (1-2 times), moderate (3-5 times), or severe (> 5 times) based on the number of coughs within the 1 min following the fentanyl injection. Assisted mask ventilation with oxygen was supplied if desaturation occurred (SpO2 < 90%).
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startMar 2011
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fentanyl-induced CoughingStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Armed Forces General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Huei-Chi Horng, MD, Taichung Armed Forces General Hospital
- Investigators
- Chih-Shung Wong, PhD, Study director, Cathay General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532466
- Sponsor's protocol ID
- TC100-5
- Status last verified
- Dec 2011
- First submitted
- 7 Feb 2012
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing
- ClinicalTrials.gov ID
- NCT01532466
- Acronym / sponsor ID
- TC100-5
- Conditions
- Fentanyl-induced Coughing
- Keywords
- fentanyl-induced coughing, rocuronium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Taichung Armed Forces General HospitalOther government
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 Feb 2012 (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.
An intravenous bolus of fentanyl often induces a cough reflex. This study investigates whether priming with rocuronium can attenuate fentanyl-induced coughing effectively.
Detailed description
Fentanyl is widely used for analgesia and anesthesia because of its rapid onset, its intense analgesic effect, and is associated with lessened cardiovascular depression and low histamine release. Although the cough reflex is usually transient and self-limiting, it should be avoided in situations such as elevated intracranial, intraocular, or intra-abdominal pressure, and unstable hemodynamics.
The cause of FIC is unclear. One hypothesis is that vocal cord spasms might induce coughing because of fentanyl-induced muscle rigidity and histamine release. Muscle relaxants are commonly used to treat this condition. This study hypothesizes that priming muscle relaxants could prevent or suppress FIC. This study investigates whether the muscle relaxant rocuronium attenuates FIC effectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocuronium, fentanyl-induced cough, normal saline | Experimental | Drug: RocuroniumAll patients were given oxygen via a face mask. The patients were then administered with the following medications intravenously: the rocuronium group received rocuronium 0.06 mg kg-1 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s). |
| Normal saline | No intervention | –All patients were given oxygen via a face mask. The patients were then administered with the following medications intravenously: the control group received the same volume of normal saline 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 260 ASA I-II patients,
- aged between 18 and 80 years, and undergoing various elective surgeries at Taichung Armed Forces General Hospital.
Key exclusion criteria (5 listed)
- a history of asthma,
- chronic cough,
- smoking,
- upper respiratory tract infection in the previous 2 weeks, and
- medication containing angiotensin-converting enzyme inhibitors or anesthetic premedication.
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 |
|---|---|---|
| RocuroniumAll patients were given oxygen via a face mask. The patients were then administered with the following medications intravenously: the rocuronium group received rocuronium 0.06 mg kg-1, and the control group received the same volume of normal saline 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s). | Drug | Rocuronium, fentanyl-induced cough, normal saline |
Primary outcome
Incidence of fentanyl-induced coughing
Time frame: 2 minutes
Following the fentanyl injection, another anesthetist who was blind to the pretreatment recorded the number of coughs for 1 min. The severity of coughing was graded as mild (1-2 times), moderate (3-5 times), or severe (> 5 times) based on the number of coughs within the 1 min following the fentanyl injection. Assisted mask ventilation with oxygen was supplied if desaturation occurred (SpO2 < 90%).
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 14 Feb 2012.
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.
Chih-Shung Wong, PhD study director
Cathay General 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 Rocuronium in people with Fentanyl-induced Coughing, run by Taichung Armed Forces General Hospital 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 2 inclusion and 5 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 14 Feb 2012. 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?
Incidence of fentanyl-induced coughing (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2012.