Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Dexmedetomidine

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Patients were assigned to receive 0.9% saline intranasally 45 min before surgery using a computer-generated random number table.

Patients were assigned to receive 1µg.kg-1dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table.

Patients were assigned to receive 1.5µg.kg-1 dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table.

Patients were assigned to receive 2µg.kg-1 dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table.

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

0.9% saline

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

dexmedetomidine 1µg.kg-1

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

dexmedetomidine 1.5µg.kg-1

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

Dexmedetomidine 2µg.kg-1

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.

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia	NCT02675049	Intranasal Dexm...	0.9% saline dexmedetomidine... dexmedetomidine... Dexmedetomidine...	20 Years - 60 Years	Tianjin Medical University Cancer Institute and Hospital
Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia	NCT02675049	Intranasal Dexm...	0.9% saline dexmedetomidine... dexmedetomidine... Dexmedetomidine...	20 Years - 60 Years	Tianjin Medical University Cancer Institute and Hospital

Spots Global Cancer Trial Database for intranasal dexmedetomidine breast cancer local anaesthesia