Emergence AgitationPhase 4NCT02169843
Small Doses of Dexmedetomidine for Emergence Agitation
A Phase 4 study testing Sevoflurane and Dexmedetomidine in people with Emergence Agitation, run by Tang-Du Hospital at 1 site in China.
Trial summary
Dexmedetomidine Hydrochloride is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the activity of sympathetic nerve, and reduce the adverse effects of stress reaction in anesthesia recovery period.Literatures have been reported that Dex can reduce the rate of emergence agitation of children and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Sevoflurane and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Oct 2014
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- obtain informed consent;
- patients whose selective under general anesthesia colorectal cancer or esophageal cancer radical operation time > 2h;
- the American society of anesthesiologists (ASA) class I-II;
- age>64 years old;
- BMI<28kg/㎡;
Who cannot join
- systolic pressure≥180mm Hg or<90mm Hg, diastolic pressure≥110mm Hg or< 60mm Hg;
- serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections;
- patients with difficult airway (such as Mallampati airway class III, airway abnormalities, etc.)
- HR<50times/min
- a history of mental illness or a long history of taking medicine of psychiatric drugs and chronic analgesics
- a history of alcoholism
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- diseases of the neuromuscular
- a tendency to malignant hyperthermia
- allergy to test drugs or have other contraindications
- participated in other clinical drug researches over the past 30 days
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital
Xi’an, Shanxi
Meiyan Sun, 15353575016, smyszdlz@126.com
About this study
Official title: Influence of Small Doses Dexmedetomidine to the Elderly Patients' Emergence Agitation
Dexmedetomidine Hydrochloride is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the activity of sympathetic nerve, and reduce the adverse effects of stress reaction in anesthesia recovery period.Literatures have been reported that Dex can reduce the rate of emergence agitation of children and adults,especially in elderly patients(>64 years) after using sevoflurane anesthesia.
- Conditions
- Emergence Agitation
- Being tested
- Sevoflurane, Dexmedetomidine, Placebo(for Dexmedetomidine)
- Keywords
- Dexmedetomidine,, agitation,, AFPS,, NRS,, mean arterial pressure, heart rate(HR)
- Medical subject headings
- Emergence Delirium, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevoflurome
inhale Sevoflurane
DexmedetomidineDrug
Also called Dexmedetomidine Hydrochloride Injection
intravenous pumping Dexmedetomidine 0.2µg/kg/h
Placebo(for Dexmedetomidine)Drug
Also called normal saline
normal saline mimic Dexmedetomidine, intravenous pumping 0.05ml/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane & Dexmedetomidine | Experimental | inhale Sevoflurane + intravenous pumping Remifentanil 0.1µg/kg/min + intravenous inject cisatracurium besilate 0.08mg/kg in fixed time interval + finally add sufentanil 0.15µg/kg,and intravenous pumping Dexmedetomidine 0.2µg/kg/h. Receives: Drug: Sevoflurane; Drug: Dexmedetomidine |
| Sevoflurane & Placebo | Active comparator | inhale Sevoflurane + intravenous pumping Remifentanil 0.1µg/kg/min + intravenous inject cisatracurium besilate 0.08mg/kg in fixed time interval + finally add sufentanil 0.15µg/kg,and intravenous pumping Placebo(for Dexmedetomidine )0.05ml/kg/h. Receives: Drug: Sevoflurane; Drug: Placebo(for Dexmedetomidine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of agitation
stay in the PACU room after operation,measure the score of Aono's four-point scale(AFPS) every two minutes.
Measured: the duration of PACU room stay,expect 30 minutes
evaluation of pain
stay in the PACU room after operation,measure the score of numeric rating scale(NRS) every two minutes.
Measured: the duration of PACU room stay,expect 30 minutes
the amount of drugs
when stay in the hospital,measure the total doses of Nalbuphine and Fentanyl using
Measured: the duration of hospital stay,expect 5 weeks
number of agitation
when stay in the hospital, measure the number of agitation.
Measured: the duration of hospital stay,expect 5 weeks
Secondary outcomes (2)
the mean arterial pressure
measure the mean arterial pressure at 6 time points including after pump injection of Dexmedetomidine or normal saline 10 minutes, 20 minutes,30 minutes,before pulling out the endotracheal tube,at the time of pulling out the endotracheal tube,and after pulling out the endotracheal tube 5 minutes
Measured: from the beginning of induction to skin closure, up to 1 hour
heart rate
measure the heart rate at 6 time points including after pump injection of Dexmedetomidine or normal saline 10 minutes, 20 minutes,30 minutes,before pulling out the endotracheal tube,at the time of pulling out the endotracheal tube,and after pulling out the endotracheal tube 5 minutes
Measured: from the beginning of induction to skin closure, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169843
- Sponsor's protocol ID
- 20140523 Dexmedetomidine
- Status last verified
- Jun 2014
- First submitted
- 26 May 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Small Doses Dexmedetomidine to the Elderly Patients' Emergence Agitation
- ClinicalTrials.gov ID
- NCT02169843
- Acronym / sponsor ID
- 20140523 Dexmedetomidine
- Conditions
- Emergence Agitation
- Keywords
- Dexmedetomidine,, agitation,, AFPS,, NRS,, mean arterial pressure, heart rate(HR)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 23 Jun 2014 (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.
Dexmedetomidine Hydrochloride is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the activity of sympathetic nerve, and reduce the adverse effects of stress reaction in anesthesia recovery period.Literatures have been reported that Dex can reduce the rate of emergence agitation of children and adults,especially in elderly patients(>64 years) after using sevoflurane anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane & Dexmedetomidine | Experimental | Drug: Sevoflurane, Drug: Dexmedetomidineinhale Sevoflurane + intravenous pumping Remifentanil 0.1µg/kg/min + intravenous inject cisatracurium besilate 0.08mg/kg in fixed time interval + finally add sufentanil 0.15µg/kg,and intravenous pumping Dexmedetomidine 0.2µg/kg/h. |
| Sevoflurane & Placebo | Active comparator | Drug: Sevoflurane, Drug: Placebo(for Dexmedetomidine)inhale Sevoflurane + intravenous pumping Remifentanil 0.1µg/kg/min + intravenous inject cisatracurium besilate 0.08mg/kg in fixed time interval + finally add sufentanil 0.15µg/kg,and intravenous pumping Placebo(for Dexmedetomidine )0.05ml/kg/h. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- obtain informed consent;
- patients whose selective under general anesthesia colorectal cancer or esophageal cancer radical operation time > 2h;
- the American society of anesthesiologists (ASA) class I-II;
- age>64 years old;
- BMI<28kg/㎡;
Key exclusion criteria (10 listed)
- systolic pressure≥180mm Hg or<90mm Hg, diastolic pressure≥110mm Hg or< 60mm Hg;
- serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections;
- patients with difficult airway (such as Mallampati airway class III, airway abnormalities, etc.)
- HR<50times/min
- a history of mental illness or a long history of taking medicine of psychiatric drugs and chronic analgesics
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 |
|---|---|---|
| SevofluraneAlso: Sevofluromeinhale Sevoflurane | Drug | Sevoflurane & Dexmedetomidine, Sevoflurane & Placebo |
| DexmedetomidineAlso: Dexmedetomidine Hydrochloride Injectionintravenous pumping Dexmedetomidine 0.2µg/kg/h | Drug | Sevoflurane & Dexmedetomidine |
| Placebo(for Dexmedetomidine)Also: normal salinenormal saline mimic Dexmedetomidine, intravenous pumping 0.05ml/kg/h | Drug | Sevoflurane & Placebo |
Primary outcome
evaluation of agitation
Time frame: the duration of PACU room stay,expect 30 minutes
stay in the PACU room after operation,measure the score of Aono's four-point scale(AFPS) every two minutes.
evaluation of pain
Time frame: the duration of PACU room stay,expect 30 minutes
stay in the PACU room after operation,measure the score of numeric rating scale(NRS) every two minutes.
the amount of drugs
Time frame: the duration of hospital stay,expect 5 weeks
when stay in the hospital,measure the total doses of Nalbuphine and Fentanyl using
number of agitation
Time frame: the duration of hospital stay,expect 5 weeks
when stay in the hospital, measure the number of agitation.
2 secondary outcomes
the mean arterial pressure
Time frame: from the beginning of induction to skin closure, up to 1 hour
heart rate
Time frame: from the beginning of induction to skin closure, up to 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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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 Sevoflurane and Dexmedetomidine in people with Emergence Agitation, run by Tang-Du Hospital 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 5 inclusion and 10 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 23 Jun 2014. 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. 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 Meiyan Sun (15353575016, smyszdlz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of agitation (time frame: the duration of PACU room stay,expect 30 minutes). The study lists 4 primary outcomes in all. 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 23 Jun 2014; AzTrials last refreshed its copy on 7 Nov 2026.