Nausea and Vomiting, PostoperativeNCT06302673
The Role Of Laserpuncture For Prevention Of Nausea And Vomiting Post Strabismus Surgery With General Anesthesia In Adult Patients
A study testing Laserpuncture in people with Nausea and Vomiting, Postoperative, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Nausea and Vomiting, Postoperative
- What is being tested?
- Laserpuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 9 Oct 2023to 5 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 18-59 years.
- Patients undergoing simple strabismus surgery involving no more than two muscles without transposition under general anesthesia.
- Meets the ASA (American Society of Anesthesiologists) score of 1-2.
- Complete the surgical preparations according to the presedation sheet.
- Sign the informed consent sheet.
- Patients who can communicate with the research team.
- Patients undergoing surgery <3 hours.
Who cannot join
- The patient is pregnant.
- Patients who have a history of drug or drug abuse.
- Patients with hypersensitivity to laser light.
- There are wounds or skin disorders at the radiation site (skin TB, SLE(Systemic Lupus Erythematosus) skin
- 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).
- Patients with metabolic diseases (acid-base imbalance, metabolic diseases calcium, glucose metabolism disease, hyperlactemia, mitochondrial disease, phenylketonuria)
- 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.
- Infection accompanied by high fever (temperature >38°C)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, Jakarta Special Capital Region
About this study
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.
Read the 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
- Being tested
- Laserpuncture, Sham Laserpuncture
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserpunctureDevice
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 LaserpunctureDevice
Sham Laserpuncture: The laser is turned on but not activated at each acupuncture point ( PC6 Neiguan and CV12 Zhongwan).
| Study group | Role | What they receive |
|---|---|---|
| Laserpuncture | Experimental | 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) Receives: Device: Laserpuncture |
| Sham-Laserpuncture | Sham comparator | Sham Laserpuncture: The laser is turned on but not activated at each acupuncture point ( PC6 Neiguan and CV12 Zhongwan) Receives: Device: Sham Laserpuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes after surgery, 2 hours after surgery, 6 hours after surgery, and 12 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start9 Oct 2023
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting, PostoperativeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded randomized controlled trial (RCT)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yossie Faudina Putri, Universitas Indonesia
- Investigators
- KEPK FKUI-RSCM, Principal investigator, The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302673
- Sponsor's protocol ID
- 23081229
- Status last verified
- Sep 2024
- First submitted
- 4 Mar 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Of Laserpuncture For Prevention Of Nausea And Vomiting Post Strabismus Surgery With General Anesthesia In Adult Patients
- ClinicalTrials.gov ID
- NCT06302673
- Acronym / sponsor ID
- 23081229
- Conditions
- Nausea and Vomiting, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Laserpuncture | Experimental | Device: LaserpunctureLaserpuncture : 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 comparator | Device: Sham LaserpunctureSham Laserpuncture: The laser is turned on but not activated at each acupuncture point ( PC6 Neiguan and CV12 Zhongwan) |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult patients aged 18-59 years.
- Patients undergoing simple strabismus surgery involving no more than two muscles without transposition under general anesthesia.
- Meets the ASA (American Society of Anesthesiologists) score of 1-2.
- Complete the surgical preparations according to the presedation sheet.
- Sign the informed consent sheet.
Key exclusion criteria (8 listed)
- The patient is pregnant.
- Patients who have a history of drug or drug abuse.
- Patients with hypersensitivity to laser light.
- There are wounds or skin disorders at the radiation site (skin TB, SLE(Systemic Lupus Erythematosus) skin
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaserpunctureLaserpuncture : 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 |
| Sham LaserpunctureSham Laserpuncture: The laser is turned on but not activated at each acupuncture point ( PC6 Neiguan and CV12 Zhongwan). | Device | Sham-Laserpuncture |
Primary outcome
Analog Visual Scale for nausea vomitting
Time frame: 30 minutes after surgery, 2 hours after surgery, 6 hours after surgery, and 12 hours after surgery.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KEPK FKUI-RSCM principal investigator
The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laserpuncture in people with Nausea and Vomiting, Postoperative, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analog Visual Scale for nausea vomitting (time frame: 30 minutes after surgery, 2 hours after surgery, 6 hours after surgery, and 12 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.