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

Phase 2

Completed

• Conditions: Intranasal Dexmedetomidine Breast Cancer Local Anaesthesia
• Interventions: Drug: dexmedetomidine 1.5µg.kg-1; Drug: Dexmedetomidine 2µg.kg-1; Drug: 0.9% saline; Drug: dexmedetomidine 1µg.kg-1

• Registration Number: NCT02675049
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-27
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-05
• Last Update Submitted: 2016-02-29
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine 1.5 µg.kg-1	dexmedetomidine 1.5µg.kg-1	Patients were assigned to receive 1.5µg.kg-1 dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table.
dexmedetomidine 2 µg.kg-1	Dexmedetomidine 2µg.kg-1	Patients were assigned to receive 2µg.kg-1 dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table.
0.9% saline	0.9% saline	Patients were assigned to receive 0.9% saline intranasally 45 min before surgery using a computer-generated random number table.
dexmedetomidine 1 µg.kg-1	dexmedetomidine 1µg.kg-1	Patients were assigned to receive 1µg.kg-1dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table.

Primary Outcome Measures

Name	Time	Method
pain scores changes by pain NRS scores	before surgery,during surgery and after surgery for pain scores，assessed up to 2 hours
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

Secondary Outcome Measures

Name	Time	Method
Adverse event that is related to treatment:severe sinus bradycardia	perioperative period	bradycardia (defined as HR \< 50 bpm)
Adverse event that is related to treatment:hypotension	perioperative period	hypotension (defined as SBP \< 90 mmHg)
Adverse event that is related to treatment:nausea and vomiting	perioperative period