Clinical trial NCT06808256: Effect of Acupuncture on Hemodynamics and Pain of Post Craniotomy Patients With Mechanical Ventilation
Official title: The Effect of Acupuncture on Hemodynamics and Pain of Post Craniotomy Patients With Mechanical Ventilation in the ICU of Tangerang Regency Hospital Banten
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Craniotomy
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Arterial Pressure
timeFrame: Before therapy, Day 4
measure: Heart Rate
timeFrame: Before therapy, Day 4
measure: Respiration Rate
timeFrame: Before therapy, Day 4
measure: Oxygen Fraction
timeFrame: Before therapy, Day 4
measure: Critical care Pain Observation Tools
timeFrame: Before therapy, Day 4
Secondary outcomes:
measure: Ventilator Mode
timeFrame: Day 4
measure: Side Effect
timeFrame: Day 4
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: the Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia
name: KPEK FKUI-RSCM
role: PRINCIPAL_INVESTIGATOR
References: