AnesthesiaNCT06114771
The Evaluation of the Effect of Preoperatively Applied Throat Lozenge
A study testing strepsilis in people with Anesthesia and Pain, Postoperative, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Purpose:The aim of this study is to evaluate the effect of preoperative throat lozenge on pain relief in the postoperative period of the mucosal damage caused by intubation in patients who underwent operations in the head and neck region under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Pain, Postoperative
- What is being tested?
- strepsilis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2021to 6 Aug 2022
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being over 18 years old Having ASA I and II scores Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets
Who cannot join
- Being over 60 years old Complex intubation cases Insulin dependent diabetes Thyroid disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of the Effect of Preoperatively Applied Throat Lozenges on Postoperative Sore Throat,Cough and Hoarseness in Patients Operated Under General Anesthesia in Oral and Maxillofacial Surgery Department
Purpose:The aim of this study is to evaluate the effect of preoperative throat lozenge on pain relief in the postoperative period of the mucosal damage caused by intubation in patients who underwent operations in the head and neck region under general anesthesia.
Methods: 60 patients were included in this study who were hospitalized in the inpatient service of the Oral and Maxillofacial Surgery department, This study was single-blind and performed by the same practitioner. Throat lozenge (strepsilis) was given to patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes).The postoperative sore throat was evaluated by VAS scale (0=no pain, 10=unbearable pain), and cough and hoarseness were evaluated with a four-point Likert scale (0=absent, 3=severe) at 1, 4, 6, 12, and 24 hours.
Read the detailed description
Before the operation, blood sugar, urea, creatinine, electrolytes, prothrombin time, active partial thromboplastin time, and liver enzyme levels were determined in all patients. Hemoglobin and hematocrit determinations were made. Electrocardiography and chest radiographs were taken. Patients whose biochemical tests were within normal limits were included in our study.
The study was single-blind and performed by the same practitioner. Throat lozenge (strepsilis) was given to 30 patients, and sugar dragee in the same size and shape was given to 30 patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes). In order not to cause any complications, sugar patients were sucked and told not to chew.
Before the initiation of general anesthesia, height, weight, intubation time, mallampati score and ASA classification, the name of the operation, the start and end time of the operation, smoking, tube number, and whether spasms occurred were recorded. Patients taken to the service in the postoperative period were rested by wearing an oxygen mask. Postoperative sore throat VAS scale (0 = no pain, 10 = unbearable pain), cough, and hoarseness were assessed at 1, 4, 6, 12, and 24 hours with a four-point Likert scale (0 = absent, 3 = severe).
- Conditions
- Anesthesia, Pain, Postoperative
- Being tested
- strepsilis, Placebo
- Keywords
- Pain, Anesthesia and Analgesia, Orthognathic Surgery
- Medical subject headings
- Pain, Postoperative, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strepsilisOther
Throat lozenge (strepsilis) was given to patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes).
PlaceboOther
Sugar dragee in the same size and shape was given to 30 patients 30 minutes before the operation. In order not to cause any complications, sugar patients were sucked and told not to chew.
| Study group | Role | What they receive |
|---|---|---|
| orthognathic surgery patients / lozange | Active comparator | Throat lozenge (strepsilis) was given to 30 patients,30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes). Receives: Other: strepsilis |
| orthognathic surgery patients / candy | Placebo comparator | Sugar dragee in the same size and shape was given to 30 patients 30 minutes before the operation. In order not to cause any complications, sugar patients were sucked and told not to chew. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperatively applied Throat lozenges on postoperative Sore Throat,Cough and Hoarseness in patients operated under General Anesthesia
postoperatively; sore throat (POST)
Measured: 1, 4, 6, 12, and 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 Nov 2023
- Study start3 Mar 2021
- Primary completion5 May 2022
- Study completion6 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raha Akbarihamed, Ankara Medipol University
- Investigators
- mine CAMBAZOĞLU, Prof, Study director, Ankara University faculity of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114771
- Sponsor's protocol ID
- Ank-Medipol-01
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- 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 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effect of Preoperatively Applied Throat Lozenges on Postoperative Sore Throat,Cough and Hoarseness in Patients Operated Under General Anesthesia in Oral and Maxillofacial Surgery Department
- ClinicalTrials.gov ID
- NCT06114771
- Acronym / sponsor ID
- Ank-Medipol-01
- Conditions
- Anesthesia, Pain, Postoperative
- Keywords
- Pain, Anesthesia and Analgesia, Orthognathic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 6 Aug 2022 (actual)
- First posted
- 2 Nov 2023 (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.
Purpose:The aim of this study is to evaluate the effect of preoperative throat lozenge on pain relief in the postoperative period of the mucosal damage caused by intubation in patients who underwent operations in the head and neck region under general anesthesia.
Methods: 60 patients were included in this study who were hospitalized in the inpatient service of the Oral and Maxillofacial Surgery department, This study was single-blind and performed by the same practitioner. Throat lozenge (strepsilis) was given to patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes).The postoperative sore throat was evaluated by VAS scale (0=no pain, 10=unbearable pain), and cough and hoarseness were evaluated with a four-point Likert scale (0=absent, 3=severe) at 1, 4, 6, 12, and 24 hours.
Detailed description
Before the operation, blood sugar, urea, creatinine, electrolytes, prothrombin time, active partial thromboplastin time, and liver enzyme levels were determined in all patients. Hemoglobin and hematocrit determinations were made. Electrocardiography and chest radiographs were taken. Patients whose biochemical tests were within normal limits were included in our study.
The study was single-blind and performed by the same practitioner. Throat lozenge (strepsilis) was given to 30 patients, and sugar dragee in the same size and shape was given to 30 patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes). In order not to cause any complications, sugar patients were sucked and told not to chew.
Before the initiation of general anesthesia, height, weight, intubation time, mallampati score and ASA classification, the name of the operation, the start and end time of the operation, smoking, tube number, and whether spasms occurred were recorded. Patients taken to the service in the postoperative period were rested by wearing an oxygen mask. Postoperative sore throat VAS scale (0 = no pain, 10 = unbearable pain), cough, and hoarseness were assessed at 1, 4, 6, 12, and 24 hours with a four-point Likert scale (0 = absent, 3 = severe).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| orthognathic surgery patients / lozange | Active comparator | Other: strepsilisThroat lozenge (strepsilis) was given to 30 patients,30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes). |
| orthognathic surgery patients / candy | Placebo comparator | Other: PlaceboSugar dragee in the same size and shape was given to 30 patients 30 minutes before the operation. In order not to cause any complications, sugar patients were sucked and told not to chew. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Being over 18 years old Having ASA I and II scores Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets
Key exclusion criteria (1 listed)
- Being over 60 years old Complex intubation cases Insulin dependent diabetes Thyroid disease
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 |
|---|---|---|
| strepsilisThroat lozenge (strepsilis) was given to patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes). | Other | orthognathic surgery patients / lozange |
| PlaceboSugar dragee in the same size and shape was given to 30 patients 30 minutes before the operation. In order not to cause any complications, sugar patients were sucked and told not to chew. | Other | orthognathic surgery patients / candy |
Primary outcome
preoperatively applied Throat lozenges on postoperative Sore Throat,Cough and Hoarseness in patients operated under General Anesthesia
Time frame: 1, 4, 6, 12, and 24 hours
postoperatively; sore throat (POST)
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 2 Nov 2023.
- 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.
mine CAMBAZOĞLU, Prof study director
Ankara University faculity of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing strepsilis in people with Anesthesia and Pain, Postoperative, run by Ankara Medipol University 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 1 inclusion and 1 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 2 Nov 2023. 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?
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?
preoperatively applied Throat lozenges on postoperative Sore Throat,Cough and Hoarseness in patients operated under General Anesthesia (time frame: 1, 4, 6, 12, and 24 hours). 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 2 Nov 2023.