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Methodologies and approaches have been implemented with differing degrees of success to prevent neuraxial hypotension. Currently utilized approaches to prevent hypotension during spinal anesthetic administration consist of physical precautions such as leg restraints and compression hosiery, as well as sympathomimetic medications Through a competitive inhibition of noradrenaline uptake, heptaminol hydrochloride prevented orthostatic hypotension and increased the plasma concentration of noradrenaline. This inhibitory effect might account for a portion of the antihypotensive effect After thorough research of the literature, studies evaluating the role of preoperative oral heptaminol hydrochloride in preventing hypotension after spinal anesthesia in lower limb surgeries with tourniquets are lacking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heptaminol hydrochloride group | Active Comparator |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heptaminol Hydrochloride | Drug | heptaminol hydrochloride will be administrated in its solution form 4ml/kg. The mean dose used will be 25 drops = 150 mg and will be given 1.5 to 2 hours before spinal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension | The occurrence of hypotension is defined as SBP <90 mm Hg or <80% of baseline, after spinal anesthesia. Our hypotension outcome was a binary event (yes/no) defined as the occurrence of at least 1 episode for a patient below either threshold, versus none, across the repeated measurements. | It will be assessed in the first 20 minutes after spinal anaesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in mean arterial blood pressure after spinal anesthesia | Duration measurement of serial changes in mean arterial blood pressure after spinal anesthesia | Every 5 minutes in the first 20 minutes after spinal anesthesia then every 15 minutes until the end of operation assessed up to 3 hours after spinal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Requirements of ephedrine | The total requirements of ephedrine to treat hypotension | From the time of intrathecal injection of the anesthetic drug until the end of operation after spinal anesthesia assessed up to 3 hours after spinal anesthesia |
| Requirements of Atropine |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006535 | Heptaminol |
| ID | Term |
|---|---|
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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| Placebo | Drug | Placebo drops (identical to heptaminol drops, prepared by the hospital pharmacy) will be administered 1.5 to 2 hours before spinal anesthesia. |
|
| Changes in heart rate after spinal anesthesia |
Duration measurement of serial changes in heart rate after spinal anesthesia |
| Every 5 minutes in the first 20 minutes after spinal anesthesia then every 15 minutes until the end of operation assessed up to 3 hours after spinal anesthesia |
The total requirements of ephedrine to treat bradycardia |
| From the time of intrathecal injection of the anesthetic drug until the end of operation after spinal anesthesia assessed up to 3 hours after spinal anesthesia |