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

NCT06808256 | Completed

• 1 other identifier: 24-12-1830
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Craniotomy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Ventilator Mode

  Day 4

• Side Effect

  Day 4

Study Arms (2)

Intervention Group

EXPERIMENTAL

The acupuncture and standard therapy

Procedure: the acupuncture therapy; Other: Standard therapy

Control Group

ACTIVE COMPARATOR

Standard therapy only

Other: Standard therapy

Interventions

the acupuncture therapy PROCEDURE

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

Intervention Group

Standard therapy OTHER

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

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• KPEK FKUI-RSCM

  the Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the outcome assessors will be blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: The acupuncture therapy combined with standard therapy will be designated as the intervention group, while the standard therapy only will be designated as the control group

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 5, 2025
• Study Start: March 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: June 1, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)