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.
Age from 18 to 50 years old.
Both sexes.
American Society of Anesthesiologists (ASA) physical status I-II.
Undergoing elective orthopedic lower limb operations with a tourniquet or plastic surgeries under spinal anesthesia.
Patient refusal.
History of hypertension, cardiovascular [disorders of the heart and blood vessels and including coronary heart disease, rheumatic heart disease and other conditions], and cerebrovascular diseases [conditions that affect blood flow and the blood vessels in the brain. Problems with blood flow may occur from blood vessel narrowing (stenosis), clot formation (thrombosis), artery blockage (embolism), or blood vessel rupture (hemorrhage)].
Baseline SBP >160 mm Hg before administration of the drug.
Any contraindications to spinal anesthesia such as coagulopathy, local skin infection, swelling, trauma, or deformity.
Parallel
Heptaminol Hydrochloride
Drugheptaminol 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
Placebo
DrugPlacebo drops (identical to heptaminol drops, prepared by the hospital pharmacy) will be administered 1.5 to 2 hours before spinal anesthesia.
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.
Changes in mean arterial blood pressure after spinal anesthesia
Duration measurement of serial changes in mean arterial blood pressure after spinal anesthesia
Changes in heart rate after spinal anesthesia
Duration measurement of serial changes in heart rate after spinal anesthesia
Requirements of ephedrine
The total requirements of ephedrine to treat hypotension
Requirements of Atropine
The total requirements of ephedrine to treat bradycardia
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
