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

Study Overview
=================
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.

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

Conditions
-----------------
Intranasal Dexmedetomidine Breast Cancer Local Anaesthesia

Intervention / Treatment
-----------------
* Drug: 0.9% saline
* Drug: dexmedetomidine 1µg.kg-1
* Drug: dexmedetomidine 1.5µg.kg-1
* Drug: Dexmedetomidine 2µg.kg-1


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0.9% saline<br>Patients were assigned to receive 0.9% saline intranasally 45 min before surgery using a computer-generated random number table. | Drug: 0.9% saline<br>* 0.9% saline intranasally 45 min before surgery using a computer-generated random number table.<br>* Other names: placebo;|
| Experimental: dexmedetomidine 1 µg.kg-1<br>Patients were assigned to receive 1µg.kg-1dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table. | Drug: dexmedetomidine 1µg.kg-1<br>* dexmedetomidine 1µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.<br>* Other names: Ai Bei Ning1 µg.kg-1;|
| Experimental: dexmedetomidine 1.5 µg.kg-1<br>Patients were assigned to receive 1.5µg.kg-1 dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table. | Drug: dexmedetomidine 1.5µg.kg-1<br>* Dexmedetomidine 1.5µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.<br>* Other names: Ai Bei Ning1 µg.kg-1;|
| Experimental: dexmedetomidine 2 µg.kg-1<br>Patients were assigned to receive 2µg.kg-1 dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table. | Drug: Dexmedetomidine 2µg.kg-1<br>* dexmedetomidine 2µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.<br>* Other names: Ai Bei Ning 2µg.kg-1;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation changes using the modified Observer's Assessment of Alertness/Sedation (OAA/S) scale |  | before surgery,during surgery and after surgery for sedation changes，assessed up to 2 hours | 
| pain scores changes by pain NRS scores |  | before surgery,during surgery and after surgery for pain scores，assessed up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event that is related to treatment:severe sinus bradycardia | bradycardia (defined as HR < 50 bpm) | perioperative period | 
| Adverse event that is related to treatment:hypotension | hypotension (defined as SBP < 90 mmHg) | perioperative period | 
| Adverse event that is related to treatment:nausea and vomiting |  | perioperative period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intranasal, Dexmedetomidine, Anaesthesia, Breast Lumpectomy