Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia

NCT06564935 | Not Yet Recruiting Phase 3

• 1 other identifier: MS-186-2024
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Hypotension

  The occurrence of hypotension is defined as SBP \<90 mm Hg or \<80% of baseline, after spinal anesthesia. Our hypotension outcome was a binary event (yes/no) defined as the occurrence of at least 1 episode for a patient below either threshold, versus none, across the repeated measurements.

  It will be assessed in the first 20 minutes after spinal anaesthesia

Secondary Outcomes (2)

• Changes in mean arterial blood pressure after spinal anesthesia

  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

  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 (2)

• Requirements of ephedrine

  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

• Requirements of Atropine

  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

Study Arms (2)

Heptaminol hydrochloride group

ACTIVE COMPARATOR

Drug: Heptaminol Hydrochloride

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Heptaminol Hydrochloride 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

Heptaminol hydrochloride group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Heptaminol

Intervention Hierarchy (Ancestors)

Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anaesthesia

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 21, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08