AnesthesiaPhase 4NCT02845661
Correlation of Narcotrend Index and the Observer's Assessment of Alertness/Sedation (OAA/S) Scale
A Phase 4 study testing Dexmedetomidine in people with Anesthesia, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial summary
Narcotrend index is a widely used quantitative parameter for evaluating anesthesia and sedation levels.Dexmedetomidine is a novel sedative,providing sedation while patients remain cooperative and can be easily aroused. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Sep 2016
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA Ⅰ ~ Ⅱ women undergoing Laparoscopic surgery.
- Written informed consent from the patient or the relatives of the participating patient.
- BMI:18.0～25 kg/m2
Who cannot join
- Mental illness can not match
- epidural anesthesia contraindicated
- People who have Slow-type arrhythmias
- Chronic renal failure
- Alcohol or drug abuse
- Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, 510010
Yun Bi Chen, 15622131984 ext. 86, 645632618@qq.com
Yun Bi Chen
About this study
Official title: The Correlation of Narcotrend Index and OAA/S Scale in Monitoring Sedation Level With Different Doses of Dexmedetomidine
Narcotrend index is a widely used quantitative parameter for evaluating anesthesia and sedation levels.Dexmedetomidine is a novel sedative,providing sedation while patients remain cooperative and can be easily aroused. This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of dexmedetomidine intravenously.
Read the detailed description
60 patients,aged 20～60,American Society of Anesthesiologists (ASA) physical status ⅠorⅡ, scheduled for electively lower limb surgery undergoing combined spinal epidural anesthesia were randomly divided three group. In each group,a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia. The initial dose in group 1, group 2 and group 3 was started from 0.9 µg/kg,1.0 µg/kg and 1.1 µg/kg, respectively. HR、MAP、SpO2、the Observer's Assessment of Alertness/Sedation（OAA/S）scale and the corresponding Narcotrend index were recorded at 5-minute intervals until 30 minutes after administration. The relationship between OAA/S scale and Narcotrend index was analyzed by a Spearman analysis. The cutoff values of Narcotrend index for OAA/S≤2 were obtained by analysis of receiver operating characteristic curves(ROC).
- Conditions
- Anesthesia
- Being tested
- Dexmedetomidine
- Keywords
- Narcotrend index, OAA/S scale, Dexmedetomidine, Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexmedetomidine 0.9 µg/kg
a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 1 was started from 0.9 µg/kg
DexmedetomidineDrug
Also called Dexmedetomidine 1.0 µg/kg
a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 2 was started from 1.0 µg/kg
DexmedetomidineDrug
Also called Dexmedetomidine 1.1 µg/kg
a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 3 was started from 1.1 µg/kg
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | patients in group 1, aged 20~60, were accepted an initial dose of 0.9μg/kg dexmedetomidine over 15 min. Receives: Drug: Dexmedetomidine |
| group 2 | Experimental | patients in group 2, aged 20~60, were accepted an initial dose of 1.0μg/kg dexmedetomidine over 15 min. Receives: Drug: Dexmedetomidine |
| group 3 | Experimental | patients in group 3, aged 20~60, were accepted an initial dose of 1.1μg/kg dexmedetomidine over 15 min. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the correlation coefficient between OAA/S scale and Narcotrend index in group 1
This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 0.9 μg/kg dexmedetomidine intravenously.
Measured: at 5-minute intervals until 30 minutes after administration
the correlation coefficient between OAA/S scale and Narcotrend index in group 2
This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 1.0 μg/kg dexmedetomidine intravenously.
Measured: at 5-minute intervals until 30 minutes after administration
the correlation coefficient between OAA/S scale and Narcotrend index in group 3
This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 1.1 μg/kg dexmedetomidine intravenously.
Measured: at 5-minute intervals until 30 minutes after administration
Secondary outcomes (1)
The calculated cutoff values for OAA/S≤ 2
Measured: at 5-minute intervals until 30 minutes after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bo xu, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845661
- Sponsor's protocol ID
- Narcotrend index
- Status last verified
- Jul 2016
- First submitted
- 24 Jul 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation of Narcotrend Index and OAA/S Scale in Monitoring Sedation Level With Different Doses of Dexmedetomidine
- ClinicalTrials.gov ID
- NCT02845661
- Acronym / sponsor ID
- Narcotrend index
- Conditions
- Anesthesia
- Keywords
- Narcotrend index, OAA/S scale, Dexmedetomidine, Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 27 Jul 2016 (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.
Narcotrend index is a widely used quantitative parameter for evaluating anesthesia and sedation levels.Dexmedetomidine is a novel sedative,providing sedation while patients remain cooperative and can be easily aroused. This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of dexmedetomidine intravenously.
Detailed description
60 patients,aged 20～60,American Society of Anesthesiologists (ASA) physical status ⅠorⅡ, scheduled for electively lower limb surgery undergoing combined spinal epidural anesthesia were randomly divided three group. In each group,a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia. The initial dose in group 1, group 2 and group 3 was started from 0.9 µg/kg,1.0 µg/kg and 1.1 µg/kg, respectively. HR、MAP、SpO2、the Observer's Assessment of Alertness/Sedation（OAA/S）scale and the corresponding Narcotrend index were recorded at 5-minute intervals until 30 minutes after administration. The relationship between OAA/S scale and Narcotrend index was analyzed by a Spearman analysis. The cutoff values of Narcotrend index for OAA/S≤2 were obtained by analysis of receiver operating characteristic curves(ROC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: Dexmedetomidinepatients in group 1, aged 20~60, were accepted an initial dose of 0.9μg/kg dexmedetomidine over 15 min. |
| group 2 | Experimental | Drug: Dexmedetomidinepatients in group 2, aged 20~60, were accepted an initial dose of 1.0μg/kg dexmedetomidine over 15 min. |
| group 3 | Experimental | Drug: Dexmedetomidinepatients in group 3, aged 20~60, were accepted an initial dose of 1.1μg/kg dexmedetomidine over 15 min. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA Ⅰ ~ Ⅱ women undergoing Laparoscopic surgery.
- Written informed consent from the patient or the relatives of the participating patient.
- BMI:18.0～25 kg/m2
Key exclusion criteria (6 listed)
- Mental illness can not match
- epidural anesthesia contraindicated
- People who have Slow-type arrhythmias
- Chronic renal failure
- Alcohol or drug abuse
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: Dexmedetomidine 0.9 µg/kga bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 1 was started from 0.9 µg/kg | Drug | group 1 |
| DexmedetomidineAlso: Dexmedetomidine 1.0 µg/kga bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 2 was started from 1.0 µg/kg | Drug | group 2 |
| DexmedetomidineAlso: Dexmedetomidine 1.1 µg/kga bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 3 was started from 1.1 µg/kg | Drug | group 3 |
Primary outcome
the correlation coefficient between OAA/S scale and Narcotrend index in group 1
Time frame: at 5-minute intervals until 30 minutes after administration
This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 0.9 μg/kg dexmedetomidine intravenously.
the correlation coefficient between OAA/S scale and Narcotrend index in group 2
Time frame: at 5-minute intervals until 30 minutes after administration
This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 1.0 μg/kg dexmedetomidine intravenously.
the correlation coefficient between OAA/S scale and Narcotrend index in group 3
Time frame: at 5-minute intervals until 30 minutes after administration
This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 1.1 μg/kg dexmedetomidine intravenously.
1 secondary outcome
The calculated cutoff values for OAA/S≤ 2
Time frame: at 5-minute intervals until 30 minutes after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
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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 in people with Anesthesia, run by Guangzhou General Hospital of Guangzhou Military Command 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 3 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 1 Aug 2016. 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 bo Xu (88653387 ext. 020, xubo333@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the correlation coefficient between OAA/S scale and Narcotrend index in group 1 (time frame: at 5-minute intervals until 30 minutes after administration). The study lists 3 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 1 Aug 2016.