CoughPhase 4NCT03783676
Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia
A Phase 4 study testing Remifentanil and Normal saline in people with Cough, run by University of Vermont Medical Center.
Trial summary
The investigators want to find a way to reduce or stop patients from coughing at the end of surgery when the breathing tube is taken out. The breathing tube is removed when the participants are waking up from anesthesia, and are at the point when the participants can breathe on your own. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cough
- What is being tested?
- Remifentanil and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2019to Jun 2019
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 80
- ASA of 1-3
- Undergoing any of the following elective cases:
- thyroidectomy (partial or complete)
- parathyroidectomy
- ophthalmological surgery
- Will require endotracheal intubation.
Who cannot join
- Lean Body Mass < 20 kg,
- BMI > 45
- Presence of pulmonary dysfunction
- Any history of anaphylaxis to remifentanil
- Requiring the use of total intravenous anesthesia.
- Per the discretion of the anesthesia provider
Trial locations and contacts
No sites are listed yet.
About this study
The investigators want to find a way to reduce or stop patients from coughing at the end of surgery when the breathing tube is taken out. The breathing tube is removed when the participants are waking up from anesthesia, and are at the point when the participants can breathe on your own. In most types of surgery, coughing at this point is common, and does not affect the participants very much, if at all. But for surgery involving the eye or the head and neck, coughing right after surgery can cause bleeding at the site of surgery.
This study will use a short-acting pain drug called remifentanil at the end of surgery to prevent coughing. The investigators will give the participants this medicine for 5 to 30 minutes. The point of the study is to test if using a simple computer program to guide precise delivery of how much of the drug is given to the participants is effective at reducing or preventing coughing.
- Conditions
- Cough
- Being tested
- Remifentanil, Normal saline
- Keywords
- extubation
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Receive remifentanil bolus and infusion guided by an algorithm.
Normal salineDrug
Receive normal saline bolus and infusion guided by the remifentanil algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil group | Experimental | Will receive remifentanil bolus and infusion guided by an algorithm Receives: Drug: Remifentanil |
| Control group | Placebo comparator | Will receive normal saline bolus and infusion guided by the remifentanil algorithm Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cough
Notes presence of cough during emergence
Measured: Measured from surgical end time to patient transfer out of room, approximetly 30 minutes and up to 45 minutes
Secondary outcomes (3)
Coughing grade
Ranks severity of cough during emergence: cough was graded according to the following scoring guidelines: 0=no cough, 1=slight cough, cough without obvious contraction of the abdomen, 2=moderate cough, strong and sudden contraction of the abdomen lasting for less than 5 seconds and 3=severe cough, strong and sudden contraction of the abdomen sustained for more than 5 seconds.
Measured: Measured from surgical end time to patient transfer out of room, approximetly 30 minutes
Extubation time
Time between the termination of the anesthetic and extubation
Measured: Measured from termination of the anesthetic to extubation, approximetly 5 minutes and up to 30 minutes
Time to recovery
Time between extubation and the ability to perform purposeful movement
Measured: Measured from extubation to purposeful movement, approximetly 5 minutes and 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 posted21 Dec 2018
- Study start15 Feb 2019 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elie Sarraf, University of Vermont Medical Center
- Investigators
- Elie Sarraf, MD.CM., Principal investigator, Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783676
- Sponsor's protocol ID
- 18-0415
- Status last verified
- Dec 2018
- First submitted
- 15 Dec 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia
- ClinicalTrials.gov ID
- NCT03783676
- Acronym / sponsor ID
- 18-0415
- Conditions
- Cough
- Keywords
- extubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 15 Feb 2019 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 21 Dec 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.
The investigators want to find a way to reduce or stop patients from coughing at the end of surgery when the breathing tube is taken out. The breathing tube is removed when the participants are waking up from anesthesia, and are at the point when the participants can breathe on your own. In most types of surgery, coughing at this point is common, and does not affect the participants very much, if at all. But for surgery involving the eye or the head and neck, coughing right after surgery can cause bleeding at the site of surgery.
This study will use a short-acting pain drug called remifentanil at the end of surgery to prevent coughing. The investigators will give the participants this medicine for 5 to 30 minutes. The point of the study is to test if using a simple computer program to guide precise delivery of how much of the drug is given to the participants is effective at reducing or preventing coughing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil group | Experimental | Drug: RemifentanilWill receive remifentanil bolus and infusion guided by an algorithm |
| Control group | Placebo comparator | Drug: Normal salineWill receive normal saline bolus and infusion guided by the remifentanil algorithm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between the ages of 18 and 80
- ASA of 1-3
- Undergoing any of the following elective cases:
- Will require endotracheal intubation.
Key exclusion criteria (6 listed)
- Lean Body Mass < 20 kg,
- BMI > 45
- Presence of pulmonary dysfunction
- Any history of anaphylaxis to remifentanil
- Requiring the use of total intravenous anesthesia.
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 |
|---|---|---|
| RemifentanilReceive remifentanil bolus and infusion guided by an algorithm. | Drug | Remifentanil group |
| Normal salineReceive normal saline bolus and infusion guided by the remifentanil algorithm. | Drug | Control group |
Primary outcome
Incidence of cough
Time frame: Measured from surgical end time to patient transfer out of room, approximetly 30 minutes and up to 45 minutes
Notes presence of cough during emergence
3 secondary outcomes
Coughing grade
Time frame: Measured from surgical end time to patient transfer out of room, approximetly 30 minutes
Extubation time
Time frame: Measured from termination of the anesthetic to extubation, approximetly 5 minutes and up to 30 minutes
Time to recovery
Time frame: Measured from extubation to purposeful movement, approximetly 5 minutes and up to 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Cough
RecruitingPhase 4
Remifentanil Versus Remifentanil-Lidocaine for Tracheal Extubation After Thyroidectomy
Tracheal Extubation, Cough
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 4
A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough
Cough, Refractory Chronic Cough
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.
Elie Sarraf, MD.CM. principal investigator
Resident
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil and Normal saline in people with Cough, run by University of Vermont Medical Center.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elie Sarraf, MD.CM. ((802) 847-4259, elie.sarraf@uvmhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cough (time frame: Measured from surgical end time to patient transfer out of room, approximetly 30 minutes and up to 45 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 24 Dec 2018.