Effect of Dexamethasone on Post-spinal Hypotension
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65-85
SponsorShaheed Mohtarma Benazir Bhutto Institue of Trauma
About this trial
The goal of this clinical trial is to learn if intravenous dexamethasone is effective for prevention of post spinal hypotension in geriatric population undergoing orthopedic surgeries. The main question aim to answer is:
Does intravenous dexamethasone in participants undergoing orthopedic procedures of lower limb under spinal anesthesia prevents post spinal hypotension? Researchers are comparing two groups of participants
* Participants in (Dexamethasone Group) Group D are receiving intravenous dexamethasone 8mg preoperatively * Participants in (Placebo Group) Group P are receiving placebo preoperatively.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Dexamethasone
DrugIntravenous dexamethasone 8mg given to participants before spinal anesthesia
Placebo
Other interventionIntravenous placebo given to the participants before spinal anesthesia
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Dexamethasone GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Post spinal Anesthesia Hypotension
Hypotension will be considered if there will be 25% decrease below the baseline for (Mean Arterial Pressure) MAP and will be managed by 300 ml of (Normal Saline) NS solution with incremental intravenous 5 mg doses of ephedrine. The proportion of patients with hypotension at any time during the first 20 min after induction of the (Spinal Anesthesia) SA and before starting the surgical procedure will be considered as the outcome of the study.
Time frame
From enrollment to 30 minutes after spinal anesthesiaSponsors and contacts
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Source ClinicalTrials.gov