Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia

Cairo University (CU)

Status and phase

Not yet enrolling

Phase 3

Conditions

Hypotension After Spinal Anesthesia

Treatments

Drug: Placebo

Drug: Heptaminol Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT06564935

MS-186-2024

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.