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NCT Number: NCT06564935

Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia

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.

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Key information

Conditions

Hypotension After Spinal Anesthesia

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo

Drug

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

Primary outcomes

  1. Hypotension

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

    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.

Secondary outcomes

  1. 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

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

  2. 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

    Duration measurement of serial changes in heart rate after spinal anesthesia

Other outcomes

  1. Requirements of ephedrine

    Time frame: 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

    The total requirements of ephedrine to treat hypotension

  2. Requirements of Atropine

    Time frame: 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

    The total requirements of ephedrine to treat bradycardia

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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