Effect of Acupuncture on Hemodynamics and Pain of Post Craniotomy Patients With Mechanical Ventilation

University of Indonesia (UI)

Status: Completed

Conditions: Post Craniotomy

Treatments: Other: Standard therapy; Procedure: the acupuncture therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06808256

24-12-1830

Details and patient eligibility

About

The aim of this clinical trial is to prove that acupuncture therapy combined with standard therapy can optimize hemodynamics and reduce pain in post-craniotomy patients with mechanical ventilation. The main questions it aims to answer are:

• Is there a difference in mean arterial pressure, pulse rate, respiratory rate, oxygen fraction and pain in the acupuncture therapy group combined with standard therapy compared to standard therapy after the 3rd therapy and compared to before therapy?
• Is there a difference in changes in ventilator mode in the acupuncture therapy group combined with standard therapy compared to standard therapy after the 3rd therapy?
• Are there any side effects in the acupuncture therapy group combined with standard therapy?

Researchers will compare acupuncture therapy combined with standard therapy to standard therapy only

Participants will:

• receive acupuncture therapy for 3 consecutive days
• outcomes will be assessed after 3 days of therapy.

Full description

• Standard therapy is pharmacological therapy administered by the patient's attending anesthesiologist to research subjects in accordance with existing clinical practice guidelines. At the ICU of Tangerang District General Hospital, standard therapy administered to patients post-craniotomy with mechanical ventilation includes symptomatic therapy based on the patient's symptoms and condition (including antihypertensive medications, typically calcium channel blockers administered intravenously or orally), analgesics (typically fentanyl or morphine), and sedation (midazolam or propofol). This standard therapy is also administered according to the patient's clinical condition.
• Hemodynamic refers to parameters assess whether perfusion in the body is adequate or not, including how the heart pumps blood, how blood vessels carry blood throughout the body, and how blood nourishes and supplies oxygen to body tissues. Hemodynamic outcomes are assessed through vital signs such as blood pressure or Mean Arterial Pressure, pulse rate, respiratory rate, and oxygen requirements (FiO2).
• Critical Care Pain Observation Tools (CPOT) is a pain assessment tool for patients who are unable to communicate verbally and are on a ventilator. The assessment includes facial expressions, body movements, muscle tension, and compliance with the ventilator.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female over 18 years old
• Subjects who received craniotomy with vascular etiology
• Conscious patients with GCS over 9 before craniotomy
• Using SIMV mode mechanical ventilation
• Family willing for the patient to participate in the study until completion and signed informed consent

Exclusion criteria

• History of neuromusculoskeletal diseases such as myasthenia gravis or multiple sclerosis
• Treatment for lung cancer and COVID-19
• There is infection, scarring or malignancy in the acupuncture stabbing area
• Patients with blood clotting disorders, platelets under 50. 000/µl, patients on anticoagulant therapy with INR over 2.0

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Intervention Group

Experimental group

Description:

The acupuncture and standard therapy

Treatment:

Other: Standard therapy

Procedure: the acupuncture therapy

Control Group

Active Comparator group

Description:

Standard therapy only

Treatment:

Other: Standard therapy