Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia

NCT ID: NCT06564935

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2025-03-31

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.

Conditions

Hypotension After Spinal Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Heptaminol hydrochloride group

Group Type: ACTIVE_COMPARATOR

Heptaminol Hydrochloride

Intervention Type: DRUG

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

Placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo drops (identical to heptaminol drops, prepared by the hospital pharmacy) will be administered 1.5 to 2 hours before spinal anesthesia.

Interventions

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

Intervention Type: DRUG

Placebo

Placebo drops (identical to heptaminol drops, prepared by the hospital pharmacy) will be administered 1.5 to 2 hours before spinal anesthesia.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

AbdElKhalik Mahmoud Shaban

Lecturer of anaesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MS-186-2024

Identifier Type: -

Identifier Source: org_study_id