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

NCT ID: NCT02675049

Last Updated: 2016-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-02-29

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.

Conditions

Intranasal Dexmedetomidine Breast Cancer Local Anaesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.9% saline

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

Group Type: PLACEBO_COMPARATOR

0.9% saline

Intervention Type: DRUG

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

dexmedetomidine 1 µg.kg-1

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

Group Type: EXPERIMENTAL

dexmedetomidine 1µg.kg-1

Intervention Type: DRUG

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

dexmedetomidine 1.5 µg.kg-1

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

Group Type: EXPERIMENTAL

dexmedetomidine 1.5µg.kg-1

Intervention Type: DRUG

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

dexmedetomidine 2 µg.kg-1

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

Group Type: EXPERIMENTAL

Dexmedetomidine 2µg.kg-1

Intervention Type: DRUG

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

Interventions

0.9% saline

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

Intervention Type: DRUG

dexmedetomidine 1µg.kg-1

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

Intervention Type: DRUG

dexmedetomidine 1.5µg.kg-1

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

Intervention Type: DRUG

Dexmedetomidine 2µg.kg-1

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

Intervention Type: DRUG

Other Intervention Names

placebo; Ai Bei Ning1 µg.kg-1; Ai Bei Ning1 µg.kg-1; Ai Bei Ning 2µg.kg-1

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MA10

Identifier Type: -

Identifier Source: org_study_id