Clinical trial · Interventional
Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia
NCT02675049CI-TRIAL-00021188completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intranasal Dexmedetomidine Breast Cancer Local Anaesthesia | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.9% saline | Drug | — | UNRESOLVED |
| dexmedetomidine 1.5µg.kg-1 | Drug | — | UNRESOLVED |
| dexmedetomidine 1µg.kg-1 | Drug | — | UNRESOLVED |
| Dexmedetomidine 2µg.kg-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- 0.9% saline
- description
- Patients were assigned to receive 0.9% saline intranasally 45 min before surgery using a computer-generated random number table.
- interventionNames
- Drug: 0.9% saline
- type
- EXPERIMENTAL
- label
- dexmedetomidine 1 µg.kg-1
- description
- Patients were assigned to receive 1µg.kg-1dexmedetomidine intranasally 45 min before surgery using a computer-generated random number table.
- interventionNames
- Drug: dexmedetomidine 1µg.kg-1
- type
- EXPERIMENTAL
- label
- dexmedetomidine 1.5 µg.kg-1
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.