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| ID | Type | Description | Link |
|---|---|---|---|
| Not funded | Other Grant/Funding Number | SMBBIT |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone Group | Experimental | Participants randomly allocated to this group will receive intravenous dexamethasone 8mg preoperatively 20 minutes before spinal anesthesia |
|
| Placebo Group | Placebo Comparator | Participants randomly allocated to this group will receive placebo preoperatively 20 minutes before spinal anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Intravenous dexamethasone 8mg given to participants before spinal anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 30 minutes after spinal anesthesia |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sidra Javed, MBBS, FCPS, Pain fellow | Contact | +92333 2474831 | sidra_dow@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaheed Mohtarma Benazir Bhutto Institute of Trauma | Recruiting | Karachi | Sindh | Pakistan |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo | Other | Intravenous placebo given to the participants before spinal anesthesia |
|
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |