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Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia

Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02675049
Enrollment
100
Registered
2016-02-05
Start date
2016-01-31
Completion date
2016-02-29
Last updated
2016-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intranasal Dexmedetomidine Breast Cancer Local Anaesthesia

Keywords

Intranasal, Dexmedetomidine, Anaesthesia, Breast Lumpectomy

Brief 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.

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.

Interventions

DRUG0.9% saline

0.9% saline intranasally 45 min before surgery using a computer-generated random number table.

DRUGdexmedetomidine 1µg.kg-1

dexmedetomidine 1µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.

DRUGdexmedetomidine 1.5µg.kg-1

Dexmedetomidine 1.5µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.

DRUGDexmedetomidine 2µg.kg-1

dexmedetomidine 2µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* with ASA(American Society of Anesthesiologists) physical status I and II * scheduled for breast lumpectomy

Exclusion criteria

* a history of heart block * upper respiratory tract infection * asthma * allergy to DEX or local anaesthetics * memory or cognitive dysfunction * pregnancy * lack of understanding the consent process * impaired liver or renal function * a history of drug or alcohol abuse

Design outcomes

Primary

MeasureTime frame
Sedation changes using the modified Observer's Assessment of Alertness/Sedation (OAA/S) scalebefore surgery,during surgery and after surgery for sedation changes,assessed up to 2 hours
pain scores changes by pain NRS scoresbefore surgery,during surgery and after surgery for pain scores,assessed up to 2 hours

Secondary

MeasureTime frameDescription
Adverse event that is related to treatment:severe sinus bradycardiaperioperative periodbradycardia (defined as HR \< 50 bpm)
Adverse event that is related to treatment:hypotensionperioperative periodhypotension (defined as SBP \< 90 mmHg)
Adverse event that is related to treatment:nausea and vomitingperioperative period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026