Intranasal Dexmedetomidine Breast Cancer Local AnaesthesiaPhase 2NCT02675049
Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia
A Phase 2 study testing 0.9% saline, dexmedetomidine 1µg.kg-1 and dexmedetomidine 1.5µg.kg-1 in people with Intranasal Dexmedetomidine Breast Cancer Local Anaesthesia, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This trial is going to evaluate the safety and effectiveness of intranasal DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia,and to investigate the optimal dose of intranasal DEX in breast lumpectomy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Intranasal Dexmedetomidine Breast Cancer Local Anaesthesia
- What is being tested?
- 0.9% saline, dexmedetomidine 1µg.kg-1 and dexmedetomidine 1.5µg.kg-1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Feb 2016
- Phase
- Phase 2
- 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
- with ASA(American Society of Anesthesiologists) physical status I and II
- scheduled for breast lumpectomy
Who cannot join
- a history of heart block
- upper respiratory tract infection
- asthma
- allergy to DEX or local anaesthetics
- memory or cognitive dysfunction
- pregnancy
Show all 9Show fewer
- lack of understanding the consent process
- impaired liver or renal function
- a history of drug or alcohol abuse
About this study
This trial is going to evaluate the safety and effectiveness of intranasal DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia,and to investigate the optimal dose of intranasal DEX in breast lumpectomy.
Read the detailed description
Breast lumpectomy associated with a high level of anxiety, fear and pain requires fast and effective anaesthesia techniques. Presently, this procedure is usually performed under general or local anaesthesia. General anaesthesia provides an effective sedation; however, for minor procedures, general anaesthesia is resource-intensive and postoperative complications, such as nausea, vomiting or extended time to ambulation, are more likely. Local anaesthesia alone may be uncomfortable or uncooperative for patients. Therefore, an efficient drug regimen is required that reduces analgesic consumption, minimises opioid-related side effects and shortens post-anaesthesia care unit (PACU) stay following surgery.
Dexmedetomidine (DEX) is a highly selective α2 adrenoreceptor agonist that provides sedation without respiratory depression. Its sedative, anxiolytic, analgesic and haemodynamic effects have made it a useful adjunct to anaesthesia and sedation. DEX may provide a conscious sedation under monitored anaesthesia care (MAC) that is a logical middle ground between general anaesthesia and local anaesthesia. Intranasal DEX was recently shown to provide satisfactory anaesthesia and premedication sedation in healthy volunteers and paediatric patients. The intranasal route is not only effective, but also well-tolerated and convenient This trial is going to evaluate the safety and effectiveness of intranasal DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia, and to investigate the optimal dose of intranasal DEX in breast lumpectomy.
- Being tested
- 0.9% saline, dexmedetomidine 1µg.kg-1, dexmedetomidine 1.5µg.kg-1, Dexmedetomidine 2µg.kg-1
- Keywords
- Intranasal, Dexmedetomidine, Anaesthesia, Breast Lumpectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% salineDrug
Also called placebo
0.9% saline intranasally 45 min before surgery using a computer-generated random number table.
dexmedetomidine 1µg.kg-1Drug
Also called Ai Bei Ning1 µg.kg-1
dexmedetomidine 1µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.
dexmedetomidine 1.5µg.kg-1Drug
Also called Ai Bei Ning1 µg.kg-1
Dexmedetomidine 1.5µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.
Dexmedetomidine 2µg.kg-1Drug
Also called Ai Bei Ning 2µg.kg-1
dexmedetomidine 2µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.
| Study group | Role | What they receive |
|---|---|---|
| 0.9% saline | Placebo comparator | Patients were assigned to receive 0.9% saline intranasally 45 min before surgery using a computer-generated random number table. Receives: Drug: 0.9% saline |
| dexmedetomidine 1 µg.kg-1 | Experimental | Patients were assigned to receive 1µg.kg-1dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table. Receives: Drug: dexmedetomidine 1µg.kg-1 |
| dexmedetomidine 1.5 µg.kg-1 | Experimental | Patients were assigned to receive 1.5µg.kg-1 dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table. Receives: Drug: dexmedetomidine 1.5µg.kg-1 |
| dexmedetomidine 2 µg.kg-1 | Experimental | Patients were assigned to receive 2µg.kg-1 dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table. Receives: Drug: Dexmedetomidine 2µg.kg-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation changes using the modified Observer's Assessment of Alertness/Sedation (OAA/S) scale
Measured: before surgery,during surgery and after surgery for sedation changes，assessed up to 2 hours
pain scores changes by pain NRS scores
Measured: before surgery,during surgery and after surgery for pain scores，assessed up to 2 hours
Secondary outcomes (3)
Adverse event that is related to treatment:severe sinus bradycardia
bradycardia (defined as HR < 50 bpm)
Measured: perioperative period
Adverse event that is related to treatment:hypotension
hypotension (defined as SBP < 90 mmHg)
Measured: perioperative period
Adverse event that is related to treatment:nausea and vomiting
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intranasal Dexmedetomidine Breast Cancer Local AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675049
- Sponsor's protocol ID
- MA10
- Status last verified
- Feb 2016
- First submitted
- 27 Jan 2016
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia
- ClinicalTrials.gov ID
- NCT02675049
- Acronym / sponsor ID
- MA10
- Keywords
- Intranasal, Dexmedetomidine, Anaesthesia, Breast Lumpectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Feb 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.
This trial is going to evaluate the safety and effectiveness of intranasal DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia,and to investigate the optimal dose of intranasal DEX in breast lumpectomy.
Detailed description
Breast lumpectomy associated with a high level of anxiety, fear and pain requires fast and effective anaesthesia techniques. Presently, this procedure is usually performed under general or local anaesthesia. General anaesthesia provides an effective sedation; however, for minor procedures, general anaesthesia is resource-intensive and postoperative complications, such as nausea, vomiting or extended time to ambulation, are more likely. Local anaesthesia alone may be uncomfortable or uncooperative for patients. Therefore, an efficient drug regimen is required that reduces analgesic consumption, minimises opioid-related side effects and shortens post-anaesthesia care unit (PACU) stay following surgery.
Dexmedetomidine (DEX) is a highly selective α2 adrenoreceptor agonist that provides sedation without respiratory depression. Its sedative, anxiolytic, analgesic and haemodynamic effects have made it a useful adjunct to anaesthesia and sedation. DEX may provide a conscious sedation under monitored anaesthesia care (MAC) that is a logical middle ground between general anaesthesia and local anaesthesia. Intranasal DEX was recently shown to provide satisfactory anaesthesia and premedication sedation in healthy volunteers and paediatric patients. The intranasal route is not only effective, but also well-tolerated and convenient This trial is going to evaluate the safety and effectiveness of intranasal DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia, and to investigate the optimal dose of intranasal DEX in breast lumpectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.9% saline | Placebo comparator | Drug: 0.9% salinePatients were assigned to receive 0.9% saline intranasally 45 min before surgery using a computer-generated random number table. |
| dexmedetomidine 1 µg.kg-1 | Experimental | Drug: dexmedetomidine 1µg.kg-1Patients were assigned to receive 1µg.kg-1dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table. |
| dexmedetomidine 1.5 µg.kg-1 | Experimental | Drug: dexmedetomidine 1.5µg.kg-1Patients were assigned to receive 1.5µg.kg-1 dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table. |
| dexmedetomidine 2 µg.kg-1 | Experimental | Drug: Dexmedetomidine 2µg.kg-1Patients were assigned to receive 2µg.kg-1 dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- with ASA(American Society of Anesthesiologists) physical status I and II
- scheduled for breast lumpectomy
Key exclusion criteria (9 listed)
- a history of heart block
- upper respiratory tract infection
- asthma
- allergy to DEX or local anaesthetics
- memory or cognitive dysfunction
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 |
|---|---|---|
| 0.9% salineAlso: placebo0.9% saline intranasally 45 min before surgery using a computer-generated random number table. | Drug | 0.9% saline |
| dexmedetomidine 1µg.kg-1Also: Ai Bei Ning1 µg.kg-1dexmedetomidine 1µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table. | Drug | dexmedetomidine 1 µg.kg-1 |
| dexmedetomidine 1.5µg.kg-1Also: Ai Bei Ning1 µg.kg-1Dexmedetomidine 1.5µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table. | Drug | dexmedetomidine 1.5 µg.kg-1 |
| Dexmedetomidine 2µg.kg-1Also: Ai Bei Ning 2µg.kg-1dexmedetomidine 2µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table. | Drug | dexmedetomidine 2 µg.kg-1 |
Primary outcome
Sedation changes using the modified Observer's Assessment of Alertness/Sedation (OAA/S) scale
Time frame: before surgery,during surgery and after surgery for sedation changes，assessed up to 2 hours
pain scores changes by pain NRS scores
Time frame: before surgery,during surgery and after surgery for pain scores，assessed up to 2 hours
3 secondary outcomes
Adverse event that is related to treatment:severe sinus bradycardia
Time frame: perioperative period
Adverse event that is related to treatment:hypotension
Time frame: perioperative period
Adverse event that is related to treatment:nausea and vomiting
Time frame: perioperative period
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 1 Mar 2016.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.9% saline, dexmedetomidine 1µg.kg-1 and dexmedetomidine 1.5µg.kg-1 in people with Intranasal Dexmedetomidine Breast Cancer Local Anaesthesia, run by Tianjin Medical University Cancer Institute and Hospital.
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 2 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: finished, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Sedation changes using the modified Observer's Assessment of Alertness/Sedation (OAA/S) scale (time frame: before surgery,during surgery and after surgery for sedation changes，assessed up to 2 hours). The study lists 2 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 Mar 2016.