Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Heptaminol Hydrochloride, Placebo.
- Who it may be relevant to
- Registry conditions: Hypotension After Spinal Anesthesia. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia in Lower Limb Surgeries With Tourniquet: A Randomized Controlled Trial
Overview
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.
Interventions
- Drug Heptaminol Hydrochloride
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 - Drug Placebo
Placebo drops (identical to heptaminol drops, prepared by the hospital pharmacy) will be administered 1.5 to 2 hours before spinal anesthesia.
Primary outcome measures
- Hypotension [Time frame: It will be assessed in the first 20 minutes after spinal anaesthesia]
Secondary outcome measures (2)
- Changes in mean arterial blood pressure after spinal anesthesia [Time frame: 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]
- Changes in heart rate after spinal anesthesia [Time frame: 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Medical conditions, which release vasoconstrictors such as pheochromocytoma.
- Patients taking vasoconstrictors or uncorrected tachyarrhythmia.
- History of drug allergy.
- Psychiatric, neuromuscular disorder, major systemic diseases.
- Pregnancy or lactating women.
- Inadequate effect of spinal anesthesia or supplemented with other types of anesthesia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06564935 · MS-186-2024