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

The Effect of Acupuncture on Hemodynamics and Pain of Post Craniotomy Patients With Mechanical Ventilation in the ICU of Tangerang Regency Hospital Banten

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.

Study Overview

• Status: Completed
• Conditions: Post Craniotomy
• Intervention / Treatment: Procedure: the acupuncture therapy; Other: Standard 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The acupuncture and standard therapy	Procedure: the acupuncture therapy; Acupuncture is performed for 3 consecutive days, using filiform needles in the chest, hands, feet area with 20 minutes retention during therapy and using press needle on the forehead which are retained for 3 days and after 3 days the stick needles will be removed. And patient continue to receive standard therapy in accordance with the clinical practice guidelines of the ICU Tangerang Hospital; Other: Standard therapy; Pharmacological therapy provided by the doctor in charge of anesthesia science patients to the research subjects was in accordance with existing clinical practice guidelines. In the ICU of Tangerang Hospital, the standard therapy given to post-craniotomy patients with mechanical ventilation is analgesic and sedation. This standard therapy is also given according to the patient's clinical condition
Active Comparator: Control Group; Standard therapy only	Other: Standard therapy; Pharmacological therapy provided by the doctor in charge of anesthesia science patients to the research subjects was in accordance with existing clinical practice guidelines. In the ICU of Tangerang Hospital, the standard therapy given to post-craniotomy patients with mechanical ventilation is analgesic and sedation. This standard therapy is also given according to the patient's clinical condition

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: KPEK FKUI-RSCM, the Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 24-12-1830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No