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

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.

Study Overview

• Status: Recruiting
• Conditions: Nausea and Vomiting, Postoperative
• Intervention / Treatment: Device: Laserpuncture and anti emetic standar therapy; Device: Sham Laserpuncture and anti emetic standar therapy

Detailed Description

The accessible population subjects in this study were adult patients who underwent strabismus surgery with general anesthesia and receive inpatient services in the building Kirana RSUPN Dr. Cipto Mangunkusumo for the period September-December 2023.

The inclusion criteria are:

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 ASA (American Society of Anesthesiologists) score 1-2. 4) Fulfill operation 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 syndrome, 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)

Sample size for each group totaling 16 people. The group of research participants will be divided into two groups, namely the actual laserpuncture group (laserpuncture + standard anti-nausea and vomiting medication) which will be called Group A and the control group (sham laserpuncture + standard anti-nausea and vomiting medication) which will be called Group B. The standard therapy for nausea and vomiting that will be given is Ondansentron 4 mg iv.

Research subjects and their guardians were given education regarding PONV risk assessment using the Apfel score before administering pre-surgical treatment, as well as assessing patient nausea and vomiting using the Analogic Visual Scale nausea and vomiting score 30 minutes, 2 hours, 6 hours and 12 hours after surgery.

In group A (laserpuncture + standard anti-nausea and vomiting medication) 1. Before strabismus surgery and the administration of preoperative laserpuncture therapy to the patient, a PONV risk assessment will be carried out using the Apfel score by the researcher or research assistant.

2. Before surgery, two hours before the patient is given anesthesia, the patient will be positioned lying down or sitting, and asepsis and antisepsis measures will be taken at the site of laserpuncture administration (PC6 Neiguan and CV12 Zhongwan). 3. The patient was then given laserpuncture therapy by the researcher once, with Nogier B wave mode settings, 50mW energy, and a dose of 2 joules. Therapy is given with a tool placed perpendicular to the surface of the PC6 Neiguan point on the right and left hand with the therapy time for each acupuncture point adjusted to the tool power and laser dose, namely 1 minute 20 seconds. After that, the same treatment was given to the CV12 Zhongwan point which is in the upper middle part of the stomach.

5. Recording and evaluating side effects that occur due to laserpuncture in patients by researchers or research assistants.

6. The patient underwent an anesthesia induction procedure and continued with strabismus surgery. 7. During surgery, the patient will be given standard anti-emetic anti-nausea-vomiting therapy in the form of Ondansetron 4 mg intravenously 8. Post-surgery, patients are assessed for nausea and vomiting by a research assistant using the Analog Visual Scale for nausea and vomiting in the surgery recovery room and in the inpatient room at 30 minutes, 2 hours, 6 hours and 12 hours after surgery.

9. If there are symptoms of nausea and vomiting, the patient can be given rescue therapy or PONV rescue treatment in the form of anti-nausea and vomiting antiemetics which are different from anti-nausea and vomiting prophylaxis/prevention 10. Side effects that occur in research subjects are recorded on the research status sheet when followed up by the research assistant.

11. All assessments and measurements are recorded and documented in the research patient data sheet.

In group B (sham laserpuncture + standard anti-nausea and vomiting medication) the same steps will be taken as group A, but when the laserpuncture therapy is carried out, the laserpuncture device is not turned on and is placed upright.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yossie Faudina Putri, MD; Phone Number: 081290371481; Email: yossie.dina2@gmail.com

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia
      • Recruiting
      • RSUPN Dr. Cipto Mangunkusumo
      • Contact: Yossie Faudina Putri, MD; Phone Number: 6281290371481; Email: yossie.dina2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laserpuncture with standard antiemetic therapy (ondansentron 4 mg iv); 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)	Device: Laserpuncture and anti emetic standar therapy; 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 Comparator: Sham Laserpuncture with standard antiemetic therapy (ondansentron 4 mg iv); Sham 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). The laser is turned on but not activated	Device: Sham Laserpuncture and anti emetic standar therapy; Laserpuncture : using RJ Laser with Nogier B wave setting, frequency 584 Hz, power 50 mW, wavelength 785 nm, at each acupuncture point ( PC6 Neiguan and CV12 Zhongwan). The laser is turned on but not activated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: KEPK FKUI-RSCM, The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Eye Diseases; Postoperative Complications; Signs and Symptoms, Digestive; Cranial Nerve Diseases; Ocular Motility Disorders; Nausea; Vomiting; Strabismus; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Antiemetics; Emetics
• Other Study ID Numbers: 23081229

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No