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Evaluating the Effect of Dexmedetomidine on Pain Management and Inflammation Reduction after Neurosurgery

Comparison of the Effect of Dexmedetomidine Administration versus Placebo (Normal Saline) on Changes in Interleukin 6 and TNF-a Levels in Patients Undergoing Neurosurgery: A Randomized Double-Blind Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160709028845N2
Enrollment
40
Registered
2025-11-20
Start date
2025-11-22
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Postoperative pain and systemic inflammatory response after neurosurgery. Other acute postprocedural pain

Interventions

Intervention 1: Intervention group: Patients in this group will receive intravenous dexmedetomidine at a loading dose of 1 µg/kg infused over 10 minutes before anesthesia induction, followed by a main

Sponsors

Abadan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with physical status I or II according to the ASA (American Society of Anesthesiologists) system Full readiness for cooperation and written informed consent Absence of chronic inflammatory diseases (such as rheumatoid arthritis or autoimmune diseases) No use of anti-inflammatory or analgesic drugs in the past week and no use of immunosuppressive drugs No history of hypersensitivity to dexmedetomidine No severe heart, liver, or kidney failure (diagnostic criteria: normal Liver Function test and EF greater than 35%) No serious complications during surgery (such as severe bleeding) No history of previous neurological disorders (such as stroke or seizure) Surgeries lasting more than 2 hours to ensure uniformity

Exclusion criteria

Exclusion criteria: Occurrence of hypersensitivity or drug reaction Patient's unwillingness to continue the study

Design outcomes

Primary

MeasureTime frame
Change in mean serum level of Interleukin-6 (IL-6) before and after surgery between the dexmedetomidine and control groups. Timepoint: Blood samples will be collected at three time points: before surgery (baseline), six hours after surgery, and twenty-four hours after surgery. Method of measurement: Serum level of Interleukin-6 will be measured using a standard enzyme-linked immunosorbent assay (ELISA) kit in the central laboratory of Abadan University of Medical Sciences.;Change in mean serum level of Tumor Necrosis Factor-Alpha (TNF-Alpha) before and after surgery between the dexmedetomidine and control groups. Timepoint: Blood samples will be collected at three time points: before surgery (baseline), six hours after surgery, and twenty-four hours after surgery. Method of measurement: Serum level of Tumor Necrosis Factor-Alpha will be measured using a standard enzyme-linked immunosorbent assay (ELISA) kit in the central laboratory of Abadan University of Medical Sciences.;Change in mean serum level of C-Reactive Protein (CRP) before and after surgery between the dexmedetomidine and control groups. Timepoint: Blood samples will be collected at three time points: before surgery (baseline), six hours after surgery, and twenty-four hours after surgery. Method of measurement: Serum level of C-Reactive Protein will be measured using a standard enzyme-linked immunosorbent assay (ELISA) kit in the central laboratory of Abadan University of Medical Sciences.

Secondary

MeasureTime frame
Postoperative pain intensity measured by the Visual Analogue Scale. Timepoint: Six hours, twelve hours, and twenty-four hours after surgery. Method of measurement: Pain intensity will be measured and recorded using a ten-centimeter Visual Analogue Scale by a trained nurse.;Total morphine requirement within the first twenty-four hours after surgery. Timepoint: From the end of surgery up to twenty-four hours postoperatively. Method of measurement: The total amount of morphine administered during the first twenty-four hours after surgery will be calculated in milligrams based on nursing records and medication charts.;Incidence of adverse events including hypotension and bradycardia during and after surgery. Timepoint: During surgery, six hours, and twenty-four hours after surgery. Method of measurement: Hemodynamic parameters including systolic and diastolic blood pressure and heart rate will be continuously monitored by the anesthesia device. Adverse events are defined as hypotension (a decrease greater than 20% from baseline) and bradycardia (heart rate below 50 beats per minute).;Changes in postoperative sedation level assessed by the Ramsey Sedation Scale. Timepoint: At the end of surgery, six hours, and twenty-four hours after surgery. Method of measurement: Sedation level will be assessed using the Ramsey Sedation Scale by the attending anesthesiologist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehdi Kiaei

Abadan University of Medical Sciences

dr.kiaei.mehdi@gmail.com+98 61 5326 5364

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026