Clinical trial NCT06564935: Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia
Official title: Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia in Lower Limb Surgeries With Tourniquet: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Hypotension After Spinal Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


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.

Primary outcomes:
measure: Hypotension
timeFrame: It will be assessed in the first 20 minutes after spinal anaesthesia
Secondary outcomes:
measure: Changes in mean arterial blood pressure after spinal anesthesia
timeFrame: 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: Changes in heart rate after spinal anesthesia
timeFrame: 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
Other outcomes:
measure: Requirements of ephedrine
timeFrame: 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
measure: Requirements of Atropine
timeFrame: 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
Locations:
Study officials:
References: