Dexamethasone and Duration of Spinal Anesthesia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-40
SponsorHoly Family Hospital, Pakistan
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dexamethasone
DrugWill receive 8mg of Dexamethasone in 100ml of Normal saline 10 minutes prior to induction of Anesthesia
Placebo
DrugWill receive 100ml Normal saline 10 minutes prior to induction of spinal anesthesia
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Group DexamethasoneActive comparator 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to Spinal Anesthesia regression
Time in minutes from administration of spinal anesthesia until sensory block regresses by two dermatomes from the maximum sensory block level.
Time frame
From administration of spinal anesthesia until sensory block regresses by two dermatomes, assessed for up to 6 hours after spinal anesthesia2
Time in minutes from administration of spinal anesthesia until the patient first requests rescue analgesia.
Time frame
From administration of spinal anesthesia until the patient's first request for rescue analgesia, assessed for up to 6 hours after spinal anesthesia.Sponsors and contacts
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Source ClinicalTrials.gov