NCT02675049

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intranasal Dexmedetomidine Breast Cancer Local Anaesthesia

Interventions

Type	Name	Description
DRUG	0.9% saline	0.9% saline intranasally 45 min before surgery using a computer-generated random number table.
DRUG	dexmedetomidine 1µg.kg-1	dexmedetomidine 1µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.
DRUG	dexmedetomidine 1.5µg.kg-1	Dexmedetomidine 1.5µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.
DRUG	Dexmedetomidine 2µg.kg-1	dexmedetomidine 2µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2016-02-05
• Last updated: 2016-03-01