Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia

Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia in Lower Limb Surgeries With Tourniquet: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypotension After Spinal Anesthesia
• Intervention / Treatment: Drug: Heptaminol Hydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: Placebo; Placebo drops (identical to heptaminol drops, prepared by the hospital pharmacy) will be administered 1.5 to 2 hours before spinal anesthesia.
Active Comparator: Heptaminol hydrochloride group	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in mean arterial blood pressure after spinal anesthesia	Duration measurement of serial 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	Duration measurement of serial 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Requirements of ephedrine	The total requirements of ephedrine to treat hypotension	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	The total requirements of ephedrine to treat bradycardia	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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: MS-186-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No