Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-01 @ 7:01 AM
Study NCT ID:
NCT06808256
Status:
COMPLETED
Last Update Posted:
2025-07-14
First Post:
2025-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acupuncture on Hemodynamics and Pain of Post Craniotomy Patients With Mechanical Ventilation
Sponsor:
Indonesia University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: