Clinical trial NCT06302673: The Role Of Laserpuncture For Prevention Of Nausea And Vomiting Post Strabismus Surgery With General Anesthesia In Adult Patients
Official title: The Role Of Laserpuncture For Prevention Of Nausea And Vomiting Post Strabismus Surgery With General Anesthesia In Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea and Vomiting, Postoperative
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded randomized controlled trial (RCT)
Primary purpose: PREVENTION

Brief summary: This study to determine the effectiveness of a combination of pre-surgical laserpuncture with standard anti-emetic therapy for PONV symptoms in adult patients after strabismus surgery under general anesthesia compared to a combination of pre-surgical placebo laserpuncture with standard anti-emetic therapy. Research design using a double blinded randomized controlled trial (RCT) where research subjects and data takers who will be disguised. The research will be carried out in the Operation and Inpatient Room, Kirana Building, RSUPN Dr. Cipto Mangunkusumo (RSCM) with research subjects as adult patients undergoing strabismus surgery under general anesthesia. Assessment of nausea and vomiting using AVS ( Analog Visual Scale) consists of scoring using a score from 1-5 which indicates the severity of nausea and vomiting.

Detailed description: This clinical trial is to evaluate the role of laserpuncture as a prevention of nausea and vomiting in adult patients after strabismus surgery under general anesthesia. Participants are 32 males/females aged 18-59 years. They will be divided into 2 groups: (1) Group laserpuncture and (2) Sham laserpuncture. The study intervention was performed 30 minutes before surgery. The primary outcome in this study was the incidence of postoperative nausea and vomiting.

Eligibility criteria: Inclusion Criteria:

1. Adult patients aged 18-59 years.
2. Patients undergoing simple strabismus surgery involving no more than two muscles without transposition under general anesthesia.
3. Meets the ASA (American Society of Anesthesiologists) score of 1-2.
4. Complete the surgical preparations according to the presedation sheet.
5. Sign the informed consent sheet.
6. Patients who can communicate with the research team.
7. Patients undergoing surgery \<3 hours.

Exclusion Criteria:

1. The patient is pregnant.
2. Patients who have a history of drug or drug abuse.
3. Patients with hypersensitivity to laser light.
4. There are wounds or skin disorders at the radiation site (skin TB, SLE(Systemic Lupus Erythematosus) skin
5. Patients who have gastrointestinal diseases (intestinal obstruction, peristaltic disorders gastrointestinal tract, gastroenteritis, irritable bowel syndrome, dyspepsia,gastroesophageal reflux disease/GERD, appendicitis, hepatitis, cholecystitis, inflammatory bowel synchrome, pancreatitis, peptic ulcer, peritonitis, food poisoning).
6. Patients with metabolic diseases (acid-base imbalance, metabolic diseases calcium, glucose metabolism disease, hyperlactemia, mitochondrial disease, phenylketonuria)
7. Patients with conditions of high intracranial pressure, head trauma, migraines, disease with symptoms of seizures, vestibular diseases, malignancies, mental and psychogenic diseases, diseases arising from consumption of drugs, nephrolithiasis, other kidney diseases, myocardial infarction, as well as the occurrence of nausea and vomiting before surgery.
8. Infection accompanied by high fever (temperature \>38°C)

Primary outcomes:
measure: Analog Visual Scale for nausea vomitting
timeFrame: 30 minutes after surgery, 2 hours after surgery, 6 hours after surgery, and 12 hours after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUPN Dr. Cipto Mangunkusumo
state: Jakarta
Study officials:
affiliation: The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
name: KEPK FKUI-RSCM
role: PRINCIPAL_INVESTIGATOR
References: