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Effect of Perioperative Lidocaine versus Dexmedetomidine on Depressive Symptoms and Sleep Quality Following Breast Cancer Surgery

Effect of Perioperative Lidocaine versus Dexmedetomidine on Depressive Symptoms and Sleep Quality Following Breast Cancer Surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250722066589N4
Enrollment
120
Registered
2026-02-03
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Breast Cancer. Condition 2: Depressive episode. Condition 3: Sleep disorders. Condition 4: Generalized Anxiety Disorder. Malignant neoplasm of breast Mood disorder due to known physiological condition with major depressive-like episode Sleep disorders Generalized anxiety disorder

Interventions

Intervention 1: The intervention group will receive intravenous dexmedetomidine. After induction of anesthesia, dexmedetomidine will be administered at a dose of 1 microgram per kilogram, followed by

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Mild to severe anxiety or depression symptoms Without systemic disease, or with controlled systemic disease

Exclusion criteria

Exclusion criteria: Patients with incomplete clinical data severe cardiac disease increased intracranial pressure epilepsy incomplete clinical data failure to complete the one-week follow-up allergy to intravenous anesthetic agents

Design outcomes

Primary

MeasureTime frame
Changes in NRS scores, opioid use, and adverse events (including cardiac complications, nausea, and dizziness). Timepoint: During the first 24 hours after surgery. Method of measurement: Numerical Rating Scale.

Secondary

MeasureTime frame
Depressive symptoms. Timepoint: on postoperative days 1, 3, and 7. Method of measurement: Patient Health Questionnaire–9 (PHQ-9).;Postoperative sleep quality improvement based on PSQI score. Timepoint: on postoperative days 1, 3, and 7. Method of measurement: The Pittsburgh Sleep Quality Index (PSQI) questionnaire.;Anxiety symptoms. Timepoint: on postoperative days 1, 3, and 7. Method of measurement: The 7-item Generalized Anxiety Disorder (GAD-7).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMalihe Abniki

Shahid Beheshti University of Medical Sciences

dr.abniki@sbmu.ac.ir+98 21 25719

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026