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; Device: Sham Laserpuncture

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.

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

Contacts and Locations

• Study Contact: Name: Yossie Faudina Putri, MD; Phone Number: +6281290371481; 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; 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; 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; Sham Laserpuncture: The laser is turned on but not activated at each acupuncture point ( PC6 Neiguan and CV12 Zhongwan)	Device: Sham Laserpuncture; Sham Laserpuncture: The laser is turned on but not activated at each acupuncture point ( PC6 Neiguan and CV12 Zhongwan).

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): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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