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

Nausea and Vomiting, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302673
• Other study ID #: 23081229
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Indonesia University
• Contact: Yossie Faudina Putri, MD
• Phone: +6281290371481
• Email: yossie.dina2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

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)

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting, Postoperative
• Postoperative Nausea and Vomiting
• Strabismus
• Vomiting

Intervention

Device:
• Laserpuncture
Laserpuncture : using RJ Laser with Nogier B wave setting, frequency 584 Hz, power 50 mW, wavelength 785 nm, and energy of 2 Joules at each acupuncture point ( PC6 Neiguan and CV12 Zhongwan)
• Sham Laserpuncture
Sham Laserpuncture: The laser is turned on but not activated at each acupuncture point ( PC6 Neiguan and CV12 Zhongwan).

Locations

Country	Name	City	State
Indonesia	RSUPN Dr. Cipto Mangunkusumo	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analog Visual Scale for nausea vomitting	PONV (post operative nausea vomiting) assessment based on the onset of nausea; vomit that has value 1-5. 1 = No nausea and vomiting. 2 = Nausea and possible vomiting tolerated, with the nausea episode can't remember by the patient or intensity nausea low with one vomiting episodes (not needed antiemetic additional inside both events). Ordinal 57 3 = Nausea and vomiting, with episodes that don't can be remembered and need antiemetic. 4 = Nausea and possible vomiting remembered clearly and need antiemetic for control symptom. 5=Nausea and persistent vomiting, with nothing symptom improvement even if given antiemetic.	30 minutes after surgery, 2 hours after surgery, 6 hours after surgery, and 12 hours after surgery.