AcupunctureNCT04910659
Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask
A study testing acupuncture in people with Acupuncture and Laryngeal Mask Airway, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
the aim of our study is to investigate if stimulation of the P6, LI4 and LI11 acupuncture points via laser acupuncture prevents sore throat caused by the classic laryngeal mask. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acupuncture, Laryngeal Mask Airway, Pain, Postoperative
- What is being tested?
- acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 30 Jul 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who recieved general anesthesia with LMA
- surgery duration < 2 hours
- between 18-60 years of age
- ASA1-2 scores
Who cannot join
- Being younger than 18 years old or being over the age of 60
- Patients with an ASA score of 3 and greater than 3
- Active infections in the area to be acupuncture.
- Prolonged bleeding time
- Liver failure
- Renal insufficiency
Show all 19Show fewer
- Pregnancy
- Heart failure 9 . Patients less than 30 kg
- 10. Uncontrolled hypertension
- 11. Uncontrolled diabetes, pheochrocytoma, thyroid dysfunction
- 12. Those who do not have the ability to read and sign the consent form
- 13. Patients with gastroesophageal reflux
- 14. History of any herbal medicine use
- 15. Patients who do not want to sign the consent form
- 16. Patients with difficult LMA placement
- 17.Patients who cannot have LMA placement at one time
- 18. Intubated patients in whom LMA could not be placed
- 19 Patients whose operation time exceeds two hours
- 20 .Patients whose operation time is less than 30 minutes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital Bilkent
Ankara
Feryal Akçay, +905459735654
About this study
Official title: Effectiveness of Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask
the aim of our study is to investigate if stimulation of the P6, LI4 and LI11 acupuncture points via laser acupuncture prevents sore throat caused by the classic laryngeal mask.
Read the detailed description
Our study is planned as a prospective, randomized, controlled, single blind. The details of the study are explained to the patients and their written informed consents are obtained.
Using the randomization program, the patients are divided into group 1 (acupuncture group) and group 2 (control group). Preoxygenation (100% oxygen with balloon and mask for 3 minutes) and midozolam 0.02 mg / kg and fentanyl 2 mcgr / kg are administered to both groups. In Group1, laser acupuncture is applied to each of the previously described P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds. In Group 2, same procedure is performed for 30 seconds while laser acupuncture closed. Then, propofol 2mg / kg is administered and a laryngeal mask is placed after 90 seconds in both groups. Maintenance anesthesia is provided with sevofurane and remifentanil infusion.
- Conditions
- Acupuncture, Laryngeal Mask Airway, Pain, Postoperative, Sore Throat
- Being tested
- acupuncture
- Keywords
- Sore Throat, Laryngeal Mask Airway, Acupuncture
- Medical subject headings
- Pain, Postoperative, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
P6, LI4 and LI 11 stimulation
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Active comparator | Group1, laser acupuncture was applied to each of the previously described P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds Receives: Other: acupuncture |
| false acupuncture | Sham comparator | P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds while laser acupuncture closed Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline sore throat at 24 h
postoperative sore throat is evaluated at 0th, 2th, 6th, 12th, 24th hours with using no, mild, moderate, severe scale.
Measured: baseline to 24 hours
Change from Baseline postoperative cough at 24 hours
postoperative cough is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent
Measured: baseline to 24 hours
Change from Baseline postoperative snoring at 24 hours
postoperative snoring is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent
Measured: baseline to 24 hours
Secondary outcomes (3)
duration of operation
Measured: 24 hour
resistance to Laringeal mask placement (none, mild, moderate, severe)
- none
- mild
- moderate
- severe
Measured: 24 hours
time taken for Laringeal mask placement (opening of the mouth for placement and time to confirmation of LMA placement with capnograph and auscultation
time from opening of the mouth for placement to confirmation of LMA placement with capnograph and auscultation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start1 Jan 2020
- Primary completion15 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- prospective randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FERYAL AKÇAY, Principal investigator, Ankara City Hospital BilkentFERYAL AKÇAY, Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910659
- Sponsor's protocol ID
- E1-19-124
- Status last verified
- Mar 2021
- First submitted
- 30 Mar 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask
- ClinicalTrials.gov ID
- NCT04910659
- Acronym / sponsor ID
- E1-19-124
- Conditions
- Acupuncture, Laryngeal Mask Airway, Pain, Postoperative, Sore Throat
- Keywords
- Sore Throat, Laryngeal Mask Airway, Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 2 Jun 2021 (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.
the aim of our study is to investigate if stimulation of the P6, LI4 and LI11 acupuncture points via laser acupuncture prevents sore throat caused by the classic laryngeal mask.
Detailed description
Our study is planned as a prospective, randomized, controlled, single blind. The details of the study are explained to the patients and their written informed consents are obtained.
Using the randomization program, the patients are divided into group 1 (acupuncture group) and group 2 (control group). Preoxygenation (100% oxygen with balloon and mask for 3 minutes) and midozolam 0.02 mg / kg and fentanyl 2 mcgr / kg are administered to both groups. In Group1, laser acupuncture is applied to each of the previously described P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds. In Group 2, same procedure is performed for 30 seconds while laser acupuncture closed. Then, propofol 2mg / kg is administered and a laryngeal mask is placed after 90 seconds in both groups. Maintenance anesthesia is provided with sevofurane and remifentanil infusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Active comparator | Other: acupunctureGroup1, laser acupuncture was applied to each of the previously described P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds |
| false acupuncture | Sham comparator | Other: acupunctureP6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds while laser acupuncture closed |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who recieved general anesthesia with LMA
- surgery duration < 2 hours
- between 18-60 years of age
- ASA1-2 scores
Key exclusion criteria (19 listed)
- Being younger than 18 years old or being over the age of 60
- Patients with an ASA score of 3 and greater than 3
- Active infections in the area to be acupuncture.
- Prolonged bleeding time
- Liver failure
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 |
|---|---|---|
| acupunctureP6, LI4 and LI 11 stimulation | Other | acupuncture, false acupuncture |
Primary outcome
Change from Baseline sore throat at 24 h
Time frame: baseline to 24 hours
postoperative sore throat is evaluated at 0th, 2th, 6th, 12th, 24th hours with using no, mild, moderate, severe scale.
Change from Baseline postoperative cough at 24 hours
Time frame: baseline to 24 hours
postoperative cough is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent
Change from Baseline postoperative snoring at 24 hours
Time frame: baseline to 24 hours
postoperative snoring is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent
3 secondary outcomes
duration of operation
Time frame: 24 hour
resistance to Laringeal mask placement (none, mild, moderate, severe)
Time frame: 24 hours
time taken for Laringeal mask placement (opening of the mouth for placement and time to confirmation of LMA placement with capnograph and auscultation
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
FERYAL AKÇAY principal investigator
Ankara City Hospital Bilkent
FERYAL AKÇAY study chair
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Acupuncture and Laryngeal Mask Airway, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 4 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 8 Jun 2021. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FERYAL AKÇAY (+905459735654, feryalkakcay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline sore throat at 24 h (time frame: baseline to 24 hours). The study lists 3 primary outcomes in all. 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 8 Jun 2021.