NCT07819682 Dexamethasone and Duration of Spinal Anesthesia

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 110 participants in total. It began in 2026-08-15 with a primary completion date of 2026-12-15.

Brief Summary

This study will evaluate whether intravenous dexamethasone affects the duration of spinal anesthesia in patients undergoing lower abdominal surgery. Eligible adult patients classified as ASA I or II will undergo routine preoperative assessment by an anesthetist. Before surgery, patients will receive either intravenous dexamethasone (8 mg diluted in 100 mL normal saline) or 100 mL normal saline alone. The medication will be administered through a peripheral intravenous cannula. Spinal anesthesia will then be performed using a standard technique. A 25-gauge spinal needle will be used to administer 12-15 mg of 0.75% hyperbaric bupivacaine into the lower lumbar region while the patient is in the sitting position. After confirming the flow of cerebrospinal fluid, the patient will be positioned for surgery. The level and effectiveness of anesthesia will be assessed using standard sensory and motor assessments. Surgery will begin after an adequate level of numbness and motor block has been achieved. The recovery of sensory and motor function will subsequently be assessed at regular 15-minute intervals by an anesthesia team member who was not involved in administering the spinal anesthesia, to minimize assessment bias. The main outcome will be the time required for the sensory block to regress from its initial level to the lower thoracic region (T10-T12). Additional outcomes will include the total duration of sensory and motor block and postoperative pain, assessed using a visual pain scale four hours after surgery. Patient information such as age, sex, diagnosis, type of surgery, duration of sensory and motor block, and postoperative pain score will be recorded and analyzed to determine whether intravenous dexamethasone prolongs the duration of spinal anesthesia.

Eligibility Criteria

Inclusion Criteria: * Patients undergoing lower abdominal surgeries and orthopaedic surgeries including pelvic and lower extremity surgeries * Patients classified as American Society of Anesthesiologists (ASA) physical status I or II Exclusion Criteria: * Patients with a history of spinal surgery, spinal instrumentation, or previous failed spinal anaesthesia * Patients with pre-existing neurological disorders, peripheral neuropathy, or sensory/motor deficits * Patients with known hypersensitivity or allergy to local anaesthetic agents or dexamethasone * Patients with congenital spinal deformities or acquired spinal conditions such as advanced spondylosis or kyphoscoliosis that may interfere with neuraxial block * Patients with contraindications to spinal anaesthesia, including coagulopathy, local infection at the injection site, or raised intracranial pressure * Patients with diabetes mellitus, chronic steroid therapy, immunosuppression, or systemic infection (due to steroid use) * Pregnant patients or those undergoing emergency surgeries

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