Image

The Role Of Laserpuncture For Prevention Of Nausea And Vomiting Post Strabismus Surgery With General Anesthesia In Adult Patients

Recruiting
18 - 59 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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

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)

Study details

Nausea and Vomiting, Postoperative

NCT06302673

Indonesia University

11 June 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.