CoughNCT03622502
The Effect of Dexmedetomidine for Emergence Cough
A study testing Dexmedetomidine, Remifentanil and Normal saline in people with Cough, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Dexmedetomidine or remifentanil are effective in attenuating cough during peri-extubation period after general anesthesia. The purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Cough
- What is being tested?
- Dexmedetomidine, Remifentanil and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Aug 2018to 27 Mar 2019
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I or II undergoing endoscopic sinus surgery or septoplasty under general anesthesia
Who cannot join
- predicted difficult airway
- body mass index > 35 kg/m2,
- recent upper respiratory infection
- asthma
- current smoker
- patients using angiotensin converting enzyme-inhibitors
- uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dexmedetomidine on the Remifentanil Concentration for Preventing Cough During Emergence After Propofol Anesthesia
Dexmedetomidine or remifentanil are effective in attenuating cough during peri-extubation period after general anesthesia. The purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence.
Read the detailed description
Administration of dexmedetomidine before end of surgery could reduce airway reflexes and hemodynamic changes during tracheal extubation. Compared with remifentanil alone, administration of dexmedetomidine in combination with remifentanil is effective in relieving cough and hemodynamic changes without inhibition of respiration. The purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence using the modified up-and-down method.
- Conditions
- Cough
- Being tested
- Dexmedetomidine, Remifentanil, Normal saline
- Keywords
- dexmedetomidine, remifentanil, extubation
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Prededex
Dexmedetomidine 0.5mcg/kg was infused over 10 min before end of the surgery
RemifentanilDrug
Also called Ultiva
Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 2.0 ng/ml)
Normal salineDrug
Also called 0.9% NaCl
Normal saline was infused over 10 min before end of the surgery
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Dexmedetomidine was infused before end of surgery and remifentanil was maintained at predetermined effect-site concentration during the emergence period Receives: Drug: Dexmedetomidine; Drug: Remifentanil |
| Remifentanil | Active comparator | Normal saline was infused before end of surgery and remifentanil was maintained at predetermined effect-site concentration during the emergence period Receives: Drug: Remifentanil; Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cough
Number of cough or a strong and sudden contraction of the abdomen during periextubation periextubation periods
Measured: from end of surgery to 5 min after tracheal extubation]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start16 Aug 2018
- Primary completion22 Mar 2019
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
- Investigators
- Jong Yeop Kim, Principal investigator, Ajou University Hospital, Suwon, Gyeongki-do, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622502
- Sponsor's protocol ID
- AJIRB-MED-OBS-18-170
- Status last verified
- Jan 2020
- First submitted
- 6 Aug 2018
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim HY, Kwak HJ, Lee D, Lee JH, Min SK, Kim JY. Comparison of remifentanil concentrations with and without dexmedetomidine for the prevention of emergence cough after nasal surgery: a randomized double-blinded trial. BMC Anesthesiol. 2021 May 4;21(1):136. doi: 10.1186/s12871-021-01358-x.
PubMed 33941098
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on the Remifentanil Concentration for Preventing Cough During Emergence After Propofol Anesthesia
- ClinicalTrials.gov ID
- NCT03622502
- Acronym / sponsor ID
- AJIRB-MED-OBS-18-170
- Conditions
- Cough
- Keywords
- dexmedetomidine, remifentanil, extubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 9 Aug 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.
Dexmedetomidine or remifentanil are effective in attenuating cough during peri-extubation period after general anesthesia. The purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence.
Detailed description
Administration of dexmedetomidine before end of surgery could reduce airway reflexes and hemodynamic changes during tracheal extubation. Compared with remifentanil alone, administration of dexmedetomidine in combination with remifentanil is effective in relieving cough and hemodynamic changes without inhibition of respiration. The purpose of this study was to investigate the effect of dexmedetomidine on the remifentanil concentration for the cough suppression during anesthetic emergence using the modified up-and-down method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine, Drug: RemifentanilDexmedetomidine was infused before end of surgery and remifentanil was maintained at predetermined effect-site concentration during the emergence period |
| Remifentanil | Active comparator | Drug: Remifentanil, Drug: Normal salineNormal saline was infused before end of surgery and remifentanil was maintained at predetermined effect-site concentration during the emergence period |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I or II undergoing endoscopic sinus surgery or septoplasty under general anesthesia
Key exclusion criteria (7 listed)
- predicted difficult airway
- body mass index > 35 kg/m2,
- recent upper respiratory infection
- asthma
- current smoker
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 |
|---|---|---|
| DexmedetomidineAlso: PrededexDexmedetomidine 0.5mcg/kg was infused over 10 min before end of the surgery | Drug | Dexmedetomidine |
| RemifentanilAlso: UltivaRemifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 2.0 ng/ml) | Drug | Dexmedetomidine, Remifentanil |
| Normal salineAlso: 0.9% NaClNormal saline was infused over 10 min before end of the surgery | Drug | Remifentanil |
Primary outcome
Number of cough
Time frame: from end of surgery to 5 min after tracheal extubation]
Number of cough or a strong and sudden contraction of the abdomen during periextubation periextubation periods
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 9 Jan 2020.
- Derived from this study: PubMed 33941098Kim HY, Kwak HJ, Lee D, Lee JH, Min SK, Kim JY. Comparison of remifentanil concentrations with and without dexmedetomidine for the prevention of emergence cough after nasal surgery: a randomized double-blinded trial. BMC Anesthesiol. 2021 May 4;21(1):136. doi: 10.1186/s12871-021-01358-x.
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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.
Jong Yeop Kim principal investigator
Ajou University Hospital, Suwon, Gyeongki-do, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Remifentanil and Normal saline in people with Cough, run by Ajou University School of Medicine 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 7 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 9 Jan 2020. 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.
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?
Number of cough (time frame: from end of surgery to 5 min after tracheal extubation]). 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 NCT03622502, which also lists 1 linked publication.
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 9 Jan 2020.