Anesthesia ComplicationPhase 4EDCSTSNCT03312413
Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery
A Phase 4 study testing Dexmedetomidine Hydrochloride and Normal Saline in people with Anesthesia Complication, run by Min Su at 1 site in China.
Trial summary
Maintenance of a remifentanil infusion during anesthetic emergence has been reported to decrease the incidence of coughing and thereby help to ensure a smooth emergence. It may, however, cause respiratory depression and possibly delay emergence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia Complication
- What is being tested?
- Dexmedetomidine Hydrochloride and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2017to 31 Dec 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30Kg/m2 ≥ BMI > 18Kg/m2;
- undergoing general anesthesia;
- ASA physical status I and II
- undergoing elective thyroid surgery.
Who cannot join
- hyperthyroidism;
- preoperative bradycardia;
- liver function impairment;
- renal function impairment;
- heart function failure;
- history of asthma or COPD;
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- history of diabetes;
- cognition function impairment;
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China,Chongqing The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Su Min, MD, +86-23-89011068, ms89011068@163.com
About this study
Official title: Efficacy of Dexmedetomidine for Cough Suppression During Anesthetic Emergence in Patients Undergoing Thyroid Surgery: A Randomized, Double Blinded, Controlled Trial
Maintenance of a remifentanil infusion during anesthetic emergence has been reported to decrease the incidence of coughing and thereby help to ensure a smooth emergence. It may, however, cause respiratory depression and possibly delay emergence. The purpose of this study was to investigate the effect of different dose of dexmedetomidine infusion on cough suppression during emergence from general anesthesia in patients undergoing thyroid surgery.
American Society of Anesthesiologists physical status I-II adults undergoing elective thyroidectomy under general anesthesia are recruited and randomly allocated to receive dexmedetomidine iv infusion of 0.2μg·kg-1·h-1 (Group D1, n = 100), 0.5μg·kg-1·h-1 (Group D2, n = 100), 0.7μg·kg-1·h-1 (Group D3, n = 100) or saline (Group C, n = 100). Primary outcome is the incidence of coughing during emergence. Second outcomes include severity of coughing, which is assessed using a four-point scale; Ramsay score, Bruggrmann comfort scale score, VAS pain score are recorded. The respiratory rate (RR), heart rate (HR), and mean arterial pressure are also recorded.
- Conditions
- Anesthesia Complication
- Being tested
- Dexmedetomidine Hydrochloride, Normal Saline
- Keywords
- dexmedetomidine, coughing during anesthetic emergence, thyroid surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine HydrochlorideDrug
Dexmedetomidine Hydrochloride 0.2 μg·kg-1·h-will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
Normal SalineDrug
Normal saline 0.5 mL·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
Dexmedetomidine HydrochlorideDrug
Dexmedetomidine Hydrochloride 0.5 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
Dexmedetomidine HydrochlorideDrug
Dexmedetomidine Hydrochloride 0.7 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine low dose group | Experimental | Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.2μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery Receives: Drug: Dexmedetomidine Hydrochloride |
| Dexmedetomidine median dose group | Experimental | Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.5μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery Receives: Drug: Dexmedetomidine Hydrochloride |
| Dexmedetomidine high dose group | Experimental | Patients in this group are received dexmedetomidine hydrochloride iv infusion of 0.7μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery Receives: Drug: Dexmedetomidine Hydrochloride |
| Control group (normal saline group) | Placebo comparator | Patients in this group are received saline iv infusion of 5mL·h-1 from incision to 20-30 minutes before the end of surgery Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of coughing during anesthetic emergence
incidence of coughing within 10 minutes after extubation
Measured: within 10 minutes after endotracheal extubation
Secondary outcomes (7)
Ccoughing on a four-point scale during anesthetic emergence
Evaluate the severity of coughing within 10 minutes after extubation by a four-point scale
Measured: within 10 minutes after endotracheal extubation
Ramsay score during anesthetic emergence
Ramsay score 1min, 5min, 10min, and 30min after extubation
Measured: within 30 minutes after endotracheal extubation
Bruggrmann comfort scale score
Bruggrmann comfort scale score 30min and 24 hrs after extubation
Measured: within 24 hrs after endotracheal extubation
VAS pain score
VAS pain score 30min, 24 hrs and 48 hrs after extubation
Measured: within 48 hrs after endotracheal extubation
Respiratory rate (RR)
Respiratory rate 1min, 5min, 10min, and 30min after extubation
Measured: within 30min after endotracheal extubation
Heart rate
Heart rate 1min, 5min, 10min, and 30min after extubation
Measured: within 30 minutes after endotracheal extubation
mean arterial pressure
Mean arterial pressure 1min, 5min, 10min, and 30min after extubation
Measured: within 30 minutes after endotracheal extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start10 Aug 2017
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Su, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312413
- Sponsor's protocol ID
- CYYY2017
- Acronym
- EDCSTS
- Status last verified
- Oct 2017
- First submitted
- 4 Sep 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexmedetomidine for Cough Suppression During Anesthetic Emergence in Patients Undergoing Thyroid Surgery: A Randomized, Double Blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT03312413
- Acronym / sponsor ID
- EDCSTS / CYYY2017
- Conditions
- Anesthesia Complication
- Keywords
- dexmedetomidine, coughing during anesthetic emergence, thyroid surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Min SuUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 17 Oct 2017 (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.
Maintenance of a remifentanil infusion during anesthetic emergence has been reported to decrease the incidence of coughing and thereby help to ensure a smooth emergence. It may, however, cause respiratory depression and possibly delay emergence. The purpose of this study was to investigate the effect of different dose of dexmedetomidine infusion on cough suppression during emergence from general anesthesia in patients undergoing thyroid surgery.
American Society of Anesthesiologists physical status I-II adults undergoing elective thyroidectomy under general anesthesia are recruited and randomly allocated to receive dexmedetomidine iv infusion of 0.2μg·kg-1·h-1 (Group D1, n = 100), 0.5μg·kg-1·h-1 (Group D2, n = 100), 0.7μg·kg-1·h-1 (Group D3, n = 100) or saline (Group C, n = 100). Primary outcome is the incidence of coughing during emergence. Second outcomes include severity of coughing, which is assessed using a four-point scale; Ramsay score, Bruggrmann comfort scale score, VAS pain score are recorded. The respiratory rate (RR), heart rate (HR), and mean arterial pressure are also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine low dose group | Experimental | Drug: Dexmedetomidine HydrochloridePatients in this group are received dexmedetomidine hydrochloride iv infusion of 0.2μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery |
| Dexmedetomidine median dose group | Experimental | Drug: Dexmedetomidine HydrochloridePatients in this group are received dexmedetomidine hydrochloride iv infusion of 0.5μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery |
| Dexmedetomidine high dose group | Experimental | Drug: Dexmedetomidine HydrochloridePatients in this group are received dexmedetomidine hydrochloride iv infusion of 0.7μg·kg-1·h-1 from incision to 20-30 minutes before the end of surgery |
| Control group (normal saline group) | Placebo comparator | Drug: Normal SalinePatients in this group are received saline iv infusion of 5mL·h-1 from incision to 20-30 minutes before the end of surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 30Kg/m2 ≥ BMI > 18Kg/m2;
- undergoing general anesthesia;
- ASA physical status I and II
- undergoing elective thyroid surgery.
Key exclusion criteria (9 listed)
- hyperthyroidism;
- preoperative bradycardia;
- liver function impairment;
- renal function impairment;
- heart function failure;
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 |
|---|---|---|
| Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride 0.2 μg·kg-1·h-will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery | Drug | Dexmedetomidine low dose group |
| Normal SalineNormal saline 0.5 mL·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery | Drug | Control group (normal saline group) |
| Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride 0.5 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery | Drug | Dexmedetomidine median dose group |
| Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride 0.7 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery | Drug | Dexmedetomidine high dose group |
Primary outcome
Incidence of coughing during anesthetic emergence
Time frame: within 10 minutes after endotracheal extubation
incidence of coughing within 10 minutes after extubation
7 secondary outcomes
Ccoughing on a four-point scale during anesthetic emergence
Time frame: within 10 minutes after endotracheal extubation
Ramsay score during anesthetic emergence
Time frame: within 30 minutes after endotracheal extubation
Bruggrmann comfort scale score
Time frame: within 24 hrs after endotracheal extubation
VAS pain score
Time frame: within 48 hrs after endotracheal extubation
Respiratory rate (RR)
Time frame: within 30min after endotracheal extubation
Heart rate
Time frame: within 30 minutes after endotracheal extubation
mean arterial pressure
Time frame: within 30 minutes after endotracheal extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- 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.
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 Dexmedetomidine Hydrochloride and Normal Saline in people with Anesthesia Complication, run by Min Su at 1 site in China.
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 4 inclusion and 9 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 17 Oct 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 China. 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. 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 SU Min, M.D. (86-23-89011068, ms89011068@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of coughing during anesthetic emergence (time frame: within 10 minutes after endotracheal extubation). 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 17 Oct 2017.