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.

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

Tianjin Medical University Cancer Institute and Hospital

Symptoms and General Pathology

Seroma

Inflammation

Placement of a penrose drain after irradiation catheter is removed

A penrose drain will be placed in the lumpectomy cavity after removal of the irradiation catheter

Penrose drain placement

Harvey Bumpers, MD

The proposed study is randomised controlled trial where informed and consenting patients who have a Mammosite/SAVI device placed, are randomized into two groups: a control group that has the device removed in the traditional manner without having a drain placed, and an experimental group that will have a penrose drain placed under sterile conditions at the time of removal of their device. The drain will be placed in the same site used for the APBI device and no additional surgery will be performed. The drain will remain for 2-3 days and it will be removed by the patient at home. They will return for their routine follow-up appointments and be monitored for development of a seroma with the use of standard ultrasound and physical exam. Hypothesis: Based on the null hypothesis there will be no difference in the rate of seroma formation after the APBI device removal if a drain is placed.

The proposed study is randomised controlled trial where informed and consenting patients who have an APBI device placed, are randomized into two groups: a control group that has the device removed in the traditional manner without having a drain placed, and a experimental group that would have a penrose drain placed under sterile conditions at the time of removal of their device. The procedure will be performed at the MSU Surgery outpatient clinic by residents, the senior investigator or a trained nurse/PA. Additional data will be collected on each patient from their medical record including demographic data, cancer diagnosis, lesion size, date of procedure, date Mammosite/SAVI was inserted and removed, total dose of radiation, ER, PR, HER2Neu status, and any chemotherapy or hormone therapy being administered. Drains will remain in place for 2-3 days and will be removed by the patient upon removing the dressing. Patients will continue their antibiotic regimen prescribed while the APBI device was in place for the 2-3 days the drain is in place for infection prophylaxis. Patients will be followed for 4 weeks to determine if a seroma or other complication has developed. Patients in both the experimental and control groups will have the same standard follow up and monitoring for seroma development with the use of ultrasound. All postop cancer care will be standard and this study will not alter or delay any aspect of breast cancer treatment. Statistics will be performed and reported based upon data collected.

Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal

The patient will be evaluated by physical exam and ultrasound of the affected breast.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal	NCT02390661	Infected Seroma...	Penrose drain p...	45 Years -	Michigan State University

Spots Global Cancer Trial Database for breast lumpectomy