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

NCT ID: NCT06302673

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-09
• Study Completion Date: 2024-09-05

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.

Conditions

Nausea and Vomiting, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Laserpuncture

Intervention Type: DEVICE

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)

Group Type: SHAM_COMPARATOR

Sham Laserpuncture

Intervention Type: DEVICE

Sham Laserpuncture: The laser is turned on but not activated at each acupuncture point ( PC6 Neiguan and CV12 Zhongwan).

Interventions

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)

Intervention Type: DEVICE

Sham Laserpuncture

Sham Laserpuncture: The laser is turned on but not activated at each acupuncture point ( PC6 Neiguan and CV12 Zhongwan).

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Yossie Faudina Putri

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KEPK FKUI-RSCM

Role: PRINCIPAL_INVESTIGATOR

The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital

Locations

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Other Identifiers

23081229

Identifier Type: -

Identifier Source: org_study_id