Geriatric Population, Orthopedic Surgeries, Post Spinal Anaesthesia Hypotension
Conditions
Brief summary
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.
Interventions
DRUGDexamethasone
Intravenous dexamethasone 8mg given to participants before spinal anesthesia
OTHERPlacebo
Intravenous placebo given to the participants before spinal anesthesia
Sponsors
Shaheed Mohtarma Benazir Bhutto Institue of Trauma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Patient undergoing orthopedic surgery in spinal anesthesia. ASA ≤ 2.
Exclusion criteria
Patients with history of cardiac arrhythmias. Patients with history of acute coronary syndrome. Patient with history of polytrauma. Patients with contraindication to SA (e.g., coagulopathy, thrombocytopenia, allergy to local anesthetic agent) and those on steroids or serotonin related medications (e.g., selective serotonin reuptake inhibitor) will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post spinal Anesthesia Hypotension | From enrollment to 30 minutes after spinal anesthesia | 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. |
Countries
Pakistan
Contacts
Primary ContactSidra Javed, MBBS, FCPS, Pain fellow
Outcome results
None listed