Intravenous lidocaine and dexmedetomidine for depressive symptoms and sleep quality after breast cancer surgery.
Design
In a controlled, parallel-group, double-blind clinical trial, 120 patients will be randomized 1:1 to either lidocaine (Group L) or dexmedetomidine (Group D) using a random number generator.
Settings and conduct
This study will enroll female breast cancer surgery candidates aged 18–60 years with ASA physical status I–II at Shohada‑ye Tajrish Hospital, following University Ethics Committee approval and written informed consent. Participants must exhibit mild to severe anxiety and/or depression, defined as scores >5 on the GAD‑7 and PHQ‑9 questionnaires. After anesthesia induction, patients will receive either intravenous dexmedetomidine (1 µg/kg loading dose, followed by a 0.5–1 µg/kg/h continuous infusion) or lidocaine (1.5 mg/kg loading dose, followed by a 1.5–2 mg/kg/h continuous infusion) until recovery room discharge. Postoperative follow-up will occur at 24 hours, 3 days, and 1 week.
Participants/Inclusion and exclusion criteria
Eligible female patients aged 18-60 years, with ASA class I-II undergoing cancer surgery, presented with mild to severe anxiety or depression (GAD-7 and PHQ-9 scores > 5).
Intervention groups
Patients will be randomized 1:1 to either lidocaine (Group L) or dexmedetomidine (Group D).
Main outcome variables
Reduced depression and anxiety symptoms, improved sleep quality in the first postoperative week, lower pain scores and opioid consumption, and fewer adverse effects.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250722066589N4
Registration date:2026-02-03, 1404/11/14
Registration timing:registered_while_recruiting
Last update:2026-02-03, 1404/11/14
Update count:0
Registration date
2026-02-03, 1404/11/14
Registrant information
Name
Malihe Abniki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 25719
Email address
dr.abniki@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-31, 1404/11/11
Expected recruitment end date
2026-05-22, 1405/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Perioperative Lidocaine versus Dexmedetomidine on Depressive Symptoms and Sleep Quality Following Breast Cancer Surgery
Public title
Effect of Perioperative Lidocaine versus Dexmedetomidine on Depressive Symptoms and Sleep Quality Following Breast Cancer Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to severe anxiety or depression symptoms
Without systemic disease, or with controlled systemic disease
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
Age
From 18 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation list is generated using block randomization with random number generator software, employing fixed or variable block sizes (e.g., 4 and 6) to ensure balanced patient numbers between groups. Allocation codes are placed in sequentially numbered, opaque, light-proof envelopes prepared by an independent individual uninvolved in patient treatment or evaluation. Only the admitting personnel in the operating room may open the envelope corresponding to the patient's number.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study employs a double-blind design, ensuring that patients and outcome assessors are unaware of the intervention type. An anesthesia nurse, independent of the data collection team, prepares lidocaine and dexmedetomidine to be identical in appearance (50 mL volume and color) and administers them via identically labeled syringes or infusion pumps with a random code. The research team will remain blinded until the observation period concludes, unless anesthesiologists detect clear signs of systemic toxicity or cardiovascular complications (e.g., severe bradycardia or hypotension).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs-Shahid Beheshti University of Medi
Street address
5th Floor , Vic President for Research and Tecnology , Shahid Beheshti University of Medical Sciences, Arabi Street, Yemen Street
City
Tehran
Province
Tehran
Postal code
198571734
Approval date
2026-01-11, 1404/10/21
Ethics committee reference number
IR.SBMU.RETECH.REC.1404.936
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
2
Description of health condition studied
Depressive episode
ICD-10 code
F06.32
ICD-10 code description
Mood disorder due to known physiological condition with major depressive-like episode
3
Description of health condition studied
Sleep disorders
ICD-10 code
G47
ICD-10 code description
Sleep disorders
4
Description of health condition studied
Generalized Anxiety Disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
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 outcomes
1
Description
depressive symptoms
Timepoint
on postoperative days 1, 3, and 7
Method of measurement
Patient Health Questionnaire–9 (PHQ‑9)
2
Description
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
3
Description
anxiety symptoms
Timepoint
on postoperative days 1, 3, and 7
Method of measurement
The 7-item Generalized Anxiety Disorder (GAD-7)
Intervention groups
1
Description
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 continuous infusion at a rate of 0.5–1 microgram per kilogram per hour until discharge from the recovery room.
Category
Treatment - Drugs
2
Description
The control group will receive intravenous lidocaine. After induction of anesthesia, lidocaine will be administered at a dose of 1.5 mg per kilogram as a loading dose, followed by continuous infusion at a rate of 1.5–2 mg per kilogram per hour until discharge from the recovery room.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-y- Tajrish hospital
Full name of responsible person
Malihe Abniki
Street address
Anesthesiology of Department , 4th Floor , Shihada-y Tajrish Hospital , Valiasr Street
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9201
Email
Pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
5th Floor , Vic President for Research and Tecnology , Shahid Beheshti University of Medical Sciences, Arabi Street, Yemen Street
City
Tehran
Province
Tehran
Postal code
198571734
Phone
+98 21 2243 9781
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Malihe Abniki
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology of Department , 4th Floor , Shihada-y Tajrish Hospital , Valiasr Street
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Fax
Email
dr.abniki@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Malihe Abniki
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology of Department , 4th Floor , Shihada-y Tajrish Hospital , Valiasr Street
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Fax
Email
dr.abniki@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Malihe Abniki
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology of Department , 4th Floor , Shihada-y Tajrish Hospital , Valiasr Street
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Fax
Email
dr.abniki@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data collected from the study population can potentially be shared after de‑identification of individuals.
When the data will become available and for how long
The access period begins 6 months after publication of the results
To whom data/document is available
Study data will be available to researchers employed in academic and scientific institutions, and also to those employed in industry.
Under which criteria data/document could be used
All data from our study will be available to researchers employed in academic and scientific institutions, and individuals working in industry may also apply to obtain access to the data.
From where data/document is obtainable
Dr Mlihe Abniki
What processes are involved for a request to access data/document
Data will be available six months after publication via email or written request.