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

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 Overview

• Status: Completed
• Conditions: Intranasal Dexmedetomidine Breast Cancer Local Anaesthesia
• Intervention / Treatment: Drug: 0.9% saline; Drug: dexmedetomidine 1µg.kg-1; Drug: dexmedetomidine 1.5µg.kg-1; Drug: Dexmedetomidine 2µg.kg-1

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 0.9% saline; Patients were assigned to receive 0.9% saline intranasally 45 min before surgery using a computer-generated random number table.	Drug: 0.9% saline; 0.9% saline intranasally 45 min before surgery using a computer-generated random number table.; Other Names: placebo
Experimental: 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.	Drug: dexmedetomidine 1µg.kg-1; dexmedetomidine 1µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.; Other Names: Ai Bei Ning1 µg.kg-1
Experimental: 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.	Drug: dexmedetomidine 1.5µg.kg-1; Dexmedetomidine 1.5µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.; Other Names: Ai Bei Ning1 µg.kg-1
Experimental: 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.	Drug: Dexmedetomidine 2µg.kg-1; dexmedetomidine 2µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.; Other Names: Ai Bei Ning 2µg.kg-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
pain scores changes by pain NRS scores	before surgery,during surgery and after surgery for pain scores，assessed up to 2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Estimate): March 1, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Intranasal; Anaesthesia; Breast Lumpectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: MA10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided