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

Not Applicable

Completed

• Conditions: Post Craniotomy

• Registration Number: NCT06808256
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Study First Posted: 2025-02-05
• Study Start: 2025-03-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-09
• Last Update Posted: 2025-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Respiration Rate	Before therapy, Day 4	Measurement of the participant's respiratory rate over one minute.
Critical care Pain Observation Tools	Before therapy, Day 4	Pain assessment in non-verbal and mechanically ventilated patients, including facial expressions, body movements, muscle tension, and compliance.
Mean Arterial Pressure	Before therapy, Day 4	Average arterial pressure during one cardiac cycle of systole and diastole
Oxygen Fraction	Before therapy, Day 4	Oxygen concentration in the inhaled gas mixture, as displayed on the patient monitor.
Heart Rate	Before therapy, Day 4	Measurement of the participant's pulse rate over one minute.

Secondary Outcome Measures

Name	Time	Method
Ventilator Mode	Day 4	Changes in the type of ventilator settings used for the participant.
Side Effect	Day 4	Patient-reported complaints after receiving manual acupuncture therapy.

Trial Locations

Locations (1)

Universitas Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia