Clinical trial NCT02675049: Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia
Official title: Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intranasal Dexmedetomidine Breast Cancer Local Anaesthesia
Keywords: Intranasal
Dexmedetomidine
Anaesthesia
Breast Lumpectomy
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sedation changes using the modified Observer's Assessment of Alertness/Sedation (OAA/S) scale
timeFrame: before surgery,during surgery and after surgery for sedation changes，assessed up to 2 hours
measure: pain scores changes by pain NRS scores
timeFrame: before surgery,during surgery and after surgery for pain scores，assessed up to 2 hours
Secondary outcomes:
measure: Adverse event that is related to treatment:severe sinus bradycardia
timeFrame: perioperative period
measure: Adverse event that is related to treatment:hypotension
timeFrame: perioperative period
measure: Adverse event that is related to treatment:nausea and vomiting
timeFrame: perioperative period
Other outcomes:
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