Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia

Phase 3Not Yet RecruitingNCT06564935

Cairo University160 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

160

Conditions

Hypotension After Spinal Anesthesia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Changes in mean arterial blood pressure after spinal anesthesia

Duration measurement of serial changes in mean arterial blood pressure after spinal anesthesia

Time frame: 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

Time frame: 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