Spinal AnesthesiaPhase 4NCT02099253
The Influence of Age on Dexmedetomidine Pharmacodynamic
A Phase 4 study testing Dexmedetomidine 01 and Dexmedetomidine 02 in people with Spinal Anesthesia, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial summary
Dexmedetomidine(DEX) is a novel , highly selective α2 adrenergic receptor agonists , and its selectivity for α2 receptor is 1600 times higher than α1.It also could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects .At earlier time It was approved by the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- Dexmedetomidine 01 and Dexmedetomidine 02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Ⅰ ~ Ⅱ patient undergoing lower extremity surgery
- Written informed consent from the patient or the relatives of the participating patient.
- BMI:18.5～25
Who cannot join
- Mental illness can not match
- epidural anesthesia contraindicated
- People who have Slow-type arrhythmias
- People who were language or hearing impaired
- Sensory block reached to T8 or higher.
- People who had lung infection or sleep apnea syndrome.
Show all 10Show fewer
- Pregnancy
- 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
Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, 510010
About this study
Official title: The Influence of Age on Dexmedetomidine Pharmacodynamic in Lower Extremity Surgery
Dexmedetomidine(DEX) is a novel , highly selective α2 adrenergic receptor agonists , and its selectivity for α2 receptor is 1600 times higher than α1.It also could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects .At earlier time It was approved by the FDA only for short-time sedation during mechanical ventilation of adult patients (<24h) in ICU. Because of its minimal impact on the respiratory , currently it was more and more widely used to sedate patients undergoing regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected by age and gender,such as the drug sensitivity of propofol and remifentanil is increased with age,while the current study also demonstrated that gender may influence the sedate efficacy of propofol and the sensitivity of muscle loose of rocuronium. Current studies with regard to the effects of age and gender on dexmedetomidine pharmacodynamic are rare. The study is aim to explore the right DEX dose of different Age of patients to produce suitable sedation.Dexmedetomidine be used in patients with combined spinal and epidural anesthesia for sedation,which is monitored by the BIS,during the operation.The relation between BIS values and the depth of sedation for patients is also investigated.
Read the detailed description
120 patients scheduled to undergo lower extremity surgery were included in one of three groups. Determination of median effective (ED50) doses was performed by the Dixon and Mood up-and-down method. Initial doses was 1μg/kg, with dose adjustment intervals of 0.05μg/kg, in the youth,and middle-aged group. The initial doses of DEX was 0.7 μg/kg,also with dose adjustment intervals of 0.05μg/kg.Sedative efficacy was defined as an OAA/S of ≤2, or an OAA/S of 3 but with an BIS value of ≤46, 26 min after the beginning of drug administration.
- Conditions
- Spinal Anesthesia
- Being tested
- Dexmedetomidine 01, Dexmedetomidine 02
- Keywords
- Age, Pharmacodynamics, dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 01Drug
Initial doses was 1μg/kg, with dose adjustment intervals of 0.05μg/kg.
Dexmedetomidine 02Drug
Initial doses was 0.7μg/kg, with dose adjustment intervals of 0.05μg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Youth Group | Experimental | People in this group, aged 18~39,were accepted an initial dose of 1μg/kg, with dose adjustment intervals of 0.05μg/kg. Receives: Drug: Dexmedetomidine 01 |
| Middle-aged Group | Experimental | People in this group, aged 40~64,were accepted an initial dose of 1μg/kg, with dose adjustment intervals of 0.05μg/kg. Receives: Drug: Dexmedetomidine 01 |
| Older Group | Experimental | People in this group, aged 65~80,were accepted an initial dose of 0.7μg/kg, with dose adjustment intervals of 0.05μg/kg. Receives: Drug: Dexmedetomidine 02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ED50 of DEX
The aim of our study is to define the median effective sedative doses (ED50s) of DEX to determine the effect of age on the pharmacodynamic of DEX in lower extremity surgery using the Dixon and Mood up-and-down method。
Measured: 26min after the start of the infusion
Secondary outcomes (1)
The ED95 of DEX
To determine the optimum bolus dose (ED95) of dexmedetomidine for producing adequate sedation during spinal anesthesia in lower limb orthopedic surgery.
Measured: 26min after the start of the infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
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
- NCT02099253
- Sponsor's protocol ID
- DEX Pharmacodynamics
- Status last verified
- Dec 2014
- First submitted
- 26 Mar 2014
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Park SJ, Park HJ, Choi JY, Kang HS, Choi HS. The influence of age and gender on remifentanil EC(50) for preventing rocuronium induced withdrawal movements. Korean J Anesthesiol. 2010 Mar;58(3):244-8. doi: 10.4097/kjae.2010.58.3.244. Epub 2010 Mar 29.
PubMed 20498772Kodaka M, Johansen JW, Sebel PS. The influence of gender on loss of consciousness with sevoflurane or propofol. Anesth Analg. 2005 Aug;101(2):377-381. doi: 10.1213/01.ANE.0000154534.71371.4F.
PubMed 16037147Xu B, Li Z, Zhou D, Li L, Li P, Huang H. The Influence of Age on Sensitivity to Dexmedetomidine Sedation During Spinal Anesthesia in Lower Limb Orthopedic Surgery. Anesth Analg. 2017 Dec;125(6):1907-1910. doi: 10.1213/ANE.0000000000002531.
PubMed 28991112
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Age on Dexmedetomidine Pharmacodynamic in Lower Extremity Surgery
- ClinicalTrials.gov ID
- NCT02099253
- Acronym / sponsor ID
- DEX Pharmacodynamics
- Conditions
- Spinal Anesthesia
- Keywords
- Age, Pharmacodynamics, dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Mar 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(DEX) is a novel , highly selective α2 adrenergic receptor agonists , and its selectivity for α2 receptor is 1600 times higher than α1.It also could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects .At earlier time It was approved by the FDA only for short-time sedation during mechanical ventilation of adult patients (<24h) in ICU. Because of its minimal impact on the respiratory , currently it was more and more widely used to sedate patients undergoing regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected by age and gender,such as the drug sensitivity of propofol and remifentanil is increased with age,while the current study also demonstrated that gender may influence the sedate efficacy of propofol and the sensitivity of muscle loose of rocuronium. Current studies with regard to the effects of age and gender on dexmedetomidine pharmacodynamic are rare. The study is aim to explore the right DEX dose of different Age of patients to produce suitable sedation.Dexmedetomidine be used in patients with combined spinal and epidural anesthesia for sedation,which is monitored by the BIS,during the operation.The relation between BIS values and the depth of sedation for patients is also investigated.
Detailed description
120 patients scheduled to undergo lower extremity surgery were included in one of three groups. Determination of median effective (ED50) doses was performed by the Dixon and Mood up-and-down method. Initial doses was 1μg/kg, with dose adjustment intervals of 0.05μg/kg, in the youth,and middle-aged group. The initial doses of DEX was 0.7 μg/kg,also with dose adjustment intervals of 0.05μg/kg.Sedative efficacy was defined as an OAA/S of ≤2, or an OAA/S of 3 but with an BIS value of ≤46, 26 min after the beginning of drug administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Youth Group | Experimental | Drug: Dexmedetomidine 01People in this group, aged 18~39,were accepted an initial dose of 1μg/kg, with dose adjustment intervals of 0.05μg/kg. |
| Middle-aged Group | Experimental | Drug: Dexmedetomidine 01People in this group, aged 40~64,were accepted an initial dose of 1μg/kg, with dose adjustment intervals of 0.05μg/kg. |
| Older Group | Experimental | Drug: Dexmedetomidine 02People in this group, aged 65~80,were accepted an initial dose of 0.7μg/kg, with dose adjustment intervals of 0.05μg/kg. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA Ⅰ ~ Ⅱ patient undergoing lower extremity surgery
- Written informed consent from the patient or the relatives of the participating patient.
- BMI:18.5～25
Key exclusion criteria (10 listed)
- Mental illness can not match
- epidural anesthesia contraindicated
- People who have Slow-type arrhythmias
- People who were language or hearing impaired
- Sensory block reached to T8 or higher.
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 01Initial doses was 1μg/kg, with dose adjustment intervals of 0.05μg/kg. | Drug | Middle-aged Group, Youth Group |
| Dexmedetomidine 02Initial doses was 0.7μg/kg, with dose adjustment intervals of 0.05μg/kg. | Drug | Older Group |
Primary outcome
The ED50 of DEX
Time frame: 26min after the start of the infusion
The aim of our study is to define the median effective sedative doses (ED50s) of DEX to determine the effect of age on the pharmacodynamic of DEX in lower extremity surgery using the Dixon and Mood up-and-down method。
1 secondary outcome
The ED95 of DEX
Time frame: 26min after the start of the infusion
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 15 Dec 2014.
- Background: PubMed 20498772Park SJ, Park HJ, Choi JY, Kang HS, Choi HS. The influence of age and gender on remifentanil EC(50) for preventing rocuronium induced withdrawal movements. Korean J Anesthesiol. 2010 Mar;58(3):244-8. doi: 10.4097/kjae.2010.58.3.244. Epub 2010 Mar 29.
- Background: PubMed 16037147Kodaka M, Johansen JW, Sebel PS. The influence of gender on loss of consciousness with sevoflurane or propofol. Anesth Analg. 2005 Aug;101(2):377-381. doi: 10.1213/01.ANE.0000154534.71371.4F.
- Derived from this study: PubMed 28991112Xu B, Li Z, Zhou D, Li L, Li P, Huang H. The Influence of Age on Sensitivity to Dexmedetomidine Sedation During Spinal Anesthesia in Lower Limb Orthopedic Surgery. Anesth Analg. 2017 Dec;125(6):1907-1910. doi: 10.1213/ANE.0000000000002531.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 01 and Dexmedetomidine 02 in people with Spinal 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 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: finished, as of the sponsor's last update on 15 Dec 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?
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?
The ED50 of DEX (time frame: 26min after the start of the infusion). 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 NCT02099253, which also lists 3 linked publications.
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 15 Dec 2014.