Clinical trial · Interventional
IV Dexmedetomidine vs Oral Gabapentin and Their Combination for Postoperative Analgesia in Cancer Patients Undergoing Modified Radical Mastectomy
A Randomized, Double-blind Study to Compare the Efficacy of Intravenous Dexmedetomidine Infusion, Oral Gabapentin and Their Combination on Postoperative Analgesia in Cancer Patients Undergoing Modified Radical Mastectomy
- 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)
Breast cancer is the most common malignant tumour among females with an incidence of about 2.1 million women every year.Nearly about 40-60% of breast surgery patients develop severe acute postoperative pain.⁴ Opioids are the current best standard drugs for postoperative pain relief, however, exposure to large doses of opioids leads to multiple side effects like prolonged sedation, respiratory depression, nausea, and vomiting.We are comparing two different drugs and their combination for perioperative analgesia for MRM. This work is a comparative study that aims to compare the analgesic effects of perioperative IV infusion of dexmedetomidine, preoperative oral gabapentin, and their combination in patients undergoing modified radical mastectomy surgery regarding the time of first rescue analgesia, postoperative morphine consumption, and possible complications.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Pain, Acute | — | UNRESOLVED | — |
| Pain, Postoperative | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexmedetomidine Hydrochloride 0.5 MG/ML | Drug | — | UNRESOLVED |
| Gabapentin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- D group
- description
- D group: Patients will receive two oral placebo capsules (starch capsules) 1 hour before surgery, and then will receive a loading dose of 1µg/kg of dexmedetomidine made to 50 ml using normal saline and given intravenously just before induction of anaesthesia over 10 minutes while patient vital signs monitored followed by intravenous infusion of dexmedetomidine diluted in normal saline with a dose of 0.5µg/kg/hour starts with induction of anaesthesia at a rate of 10 ml/hour through identical syringe pump until skin closure.
- interventionNames
- Drug: Dexmedetomidine Hydrochloride 0.5 MG/ML
- type
- EXPERIMENTAL
- label
- G group
- description
- G group: Patients will receive two oral gabapentin (300 mg) capsules for a total of 600 mg gabapentin (Neurontin; Pfizer, Cairo, Egypt) 1 hour before surgery, and then will receive 50 ml of normal saline given intravenously just before induction of anaesthesia over 10 minutes while patient vital signs monitored followed by intravenous normal saline infusion intraoperatively starts with induction of anaesthesia at a rate of 10 ml/hour through identical syringe pump until skin closure.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * ● Female physical status ASA I, II. * Body mass index (BMI): 20 kg/m2- 40 kg/m2. * A patient undergoing modified radical mastectomy under general anaesthesia. Exclusion Criteria: * ● Patient refusal. * Known sensitivity or contraindication to study drugs (e.g.: dexmedetomidine, gabapentin, or morphine ). * History of psychological disorders, chronic pain, and/or sympathetic disorders. * Patients receiving medications that are considered to result in tolerance to opioids as those who are receiving medications for cancer pain (e.g. tramadol and hydromorphone). * Significant liver insufficiency (liver enzymes more than two folds or severe liver cirrhosis) or renal insufficiency (plasma creatinine more than 1.5 mg/dl). * Severe respiratory disorders (e.g. Chronic obstructive pulmonary disease, Bronchial asthma), or cardiac disorders (e.g. ischemic heart disease, regional motion wall abnormality, EF\< 50%). * Pregnancy.
References
Publications (0)
Data not yet available