Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia

Last updated: August 19, 2024
Sponsor: Cairo University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Vascular Diseases

Circulation Disorders

Dizzy/fainting Spells

Treatment

Placebo

Heptaminol Hydrochloride

Clinical Study ID

NCT06564935
MS-186-2024
  • Ages 18-50
  • All Genders

Study 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

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 plasticsurgeries under spinal anesthesia.

Exclusion

Exclusion Criteria:

  • Patient refusal.

  • History of hypertension, cardiovascular [disorders of the heart and blood vesselsand including coronary heart disease, rheumatic heart disease and other conditions],and cerebrovascular diseases [conditions that affect blood flow and the bloodvessels in the brain. Problems with blood flow may occur from blood vessel narrowing (stenosis), clot formation (thrombosis), artery blockage (embolism), or blood vesselrupture (hemorrhage)].

  • Baseline SBP >160 mm Hg before administration of the drug.

  • Any contraindications to spinal anesthesia such as coagulopathy, local skininfection, 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 ofanesthesia.

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 01, 2024
Estimated Completion Date:
March 31, 2025