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NCT Number: NCT04837495

Stellate Ganglion Block in Control of Arrhythmia in Laparoscopic Cholecystectomy

During Laparoscopic cholecystectomy, carbon dioxide (CO2) pneumoperitoneal laparoscopic surgery, CO2-pneumoperitoneum activates the sympathoadrenomedullary system to increase the release of catecholamines such as epinephrine (E) norepinephrine (NE) and dopamine (DA). During stress, E and NE are secreted by the adrenal medulla into blood circulation to promote glycogenolysis to increase blood glucose, speed up lipolysis and accelerate heartbeats. Stellate g anglion block (SGB) reters to the blockade of sympathetic nerves including the large area covered by middle cervical, vertebral arterial. stellate ganglions and ther pre- and post- ganglions. SGB affects both peripheral and central nervous systems. In the peripheral system. the sympathetic pre- and post-ganglionic fibers in the innervated areas of stellate ganglion are affected. Therefore, the control of vascular dilatation and constriction, muscular movement, bronchial smooth muscle relaxation and contraction, and pain conduction, by sympathetic nerves is inhibited. In the central nervous system, the hypothalamus is mainly involved in the regulation of systemic autonomic nervous, immune and endocrine systems, and to maintain homeostasis.

CO2-pneumoperitoneum causes severe stress-related homeostatic disorders including arrhythmia and blood pressure changes. This study will examine the effects of stellate ganglion block (SGB) on hemodynamics and stress response in patients undergoing CO-pneumoperitoneal surgery.

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Key information

Conditions

Arrythmia Acute Pain Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Neurologic Manifestations Pain Pain, Acute Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emad Zarief Kamel Said

Asyut, 71111, Egypt

About this study

Laparoscopic surgery is being increasingly recognized for its advantages of minimal invasiveness. mild postoperative pain, short length of hospitalization and rapid recovery and is widely used in general surgery, obstetrics. gynecology and urology. Laparoscopic cholecystectomy (LC) has become the gold standard for surgically treating benign diseases of the gallbladder.

During carbon dioxide (CO2) pneumoperitoneal laparoscopic surgery, CO2-pneumoperitoneum activates the sympathoadrenomedullary system to increase the release of catecholamines such as epinephrine (E) norepinephrine (NE) and dopamine (DA). During stress, E and NE are secreted by the adrenal medulla into blood circulation to promote glycogenolysis to increase blood glucose, speed up lipolysis and accelerate heartbeats. Stellate g anglion block (SGB) reters to the blockade of sympathetic nerves including the large area covered by middle cervical, vertebral arterial. stellate ganglions and ther pre- and post- ganglions. SGB affects both peripheral and central nervous systems. In the peripheral system. the sympathetic pre- and post-ganglionic fibers in the innervated areas of stellate ganglion are affected. Therefore, the control of vascular dilatation and constriction, muscular movement, bronchial smooth muscle relaxation and contraction, and pain conduction, by sympathetic nerves is inhibited. In the central nervous system, the hypothalamus is mainly involved in the regulation of systemic autonomic nervous, immune and endocrine systems, and to maintain homeostasis.

CO2-pneumoperitoneum causes severe stress-related homeostatic disorders including arrhythmia and blood pressure changes. This study will examine the effects of stellate ganglion block (SGB) on hemodynamics and stress response in patients undergoing CO-pneumoperitoneal surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 -60 years
  • american society of anesthesiologists status I-II
  • Scheduled for elective laparoscopic cholecystectomy

Exclusion criteria

  • Patients with chronic renal dysfunction.
  • Patients with hypo/hyper-thyroidism.
  • Patients with diseases of the autonomic and central nervous systems.
  • Patients with cardiopulmonary dysfunction.
  • Patients with history of treatment with long-term oral tranquilizers.

Treatment and study plan

right stellate ganglion block

Procedure

The skin should be anaesthetised with lidocaine 2%. Using a lateral approach and in-plane imaging, a blunt regional anaesthesia needle should be advanced deep to the carotid sheath towards the longus colli muscle. Following careful aspiration, inject 10 ml lidocaine 2% that will result in expansion of the fascia of the longus colli. Confirmation of the SGB success can be detected by warming of left upper limb and left Horner's syndrome.

Primary outcomes

  1. Arrhythmia

    Time frame: introperative period

    the incidnese of Arrhythmia

Secondary outcomes

  1. Postoperative pain

    Time frame: 24 hours postoperatively

    Numeric Rating Scale and Visual Analog Scale will be used to evaluate post operative analgesia

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Stellate Ganglion Block Efficacy in Control of Arrhythmia and Cardiovascular Changes in Addition to, Postoperative Analgesia in Laparoscopic Cholecystectomy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2021
Registry last updated
Dec 5, 2023

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

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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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