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Trial registered on ANZCTR


Registration number
ACTRN12613000477729
Ethics application status
Approved
Date submitted
10/04/2013
Date registered
30/04/2013
Date last updated
30/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Controlled comparison between siccoral spraying, stomatovis gargle or strefen tablets to reduce postoperative sore throat in patients undergoing elective genitourinary surgery under general anesthesia with orotracheal intubation
Scientific title
Controlled comparison between siccoral spraying, stomatovis gargle or strefen tablets to reduce postoperative sore throat in patients undergoing elective genitourinary surgery under general anesthesia with orotracheal intubation
Secondary ID [1] 282309 0
nil known



Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
We are studying postoperative sore throat(POST) after general anesthesia with orotracheal intubation. 288848 0
Condition category
Condition code
Anaesthesiology 289193 289193 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study we will compare the effectiveness of these drugs in alleviating postoperative sore throat using different approaches: spraying into the oral cavity, gargling or perioperative administration of lozenges.- Strefen group(STR): Flurbiprofen 8.75 mg. Sucrose, Glucose Syrup, Honey, Macrogol 300, Lemon Flavour, Potassium Hydroxide, Levomenthol. Reckitt Benckiser Healthcare, UK; strefen lozenge will be sucked by the patient 45 minutes before induction of anesthesia.

- Siccoral group(SCR): 10 mg sea salt % 1, glyserol, patent blue, methyl paraben, prophyl paraben, purified water. Drossapharm,Basel, Switzerland; siccoral will be sprayed into the oropharyngeal cavity 4 puffs, 1minute before induction of anesthesia.

-Stomatovis group(STM): Purified water, xylitol, marshmallow mucilage, vegetable glycerol, dipotassium glycyrrhizinate, phosphoglucan, carboximethyl beta-glucan, sodium bicarbonate, chlorobutanol, PVM/MA, sodium hydroxymethyl glycinate, PEG-40 hydrogenated castor oil , acesulfame K, flavouring, green color (E102, E131, E514). Pomezia,Roma, Italy: stomatovis 15-20 ml will be gargled by the patient for at least 60 seconds before induction of anesthesia.
Active Ingredients %
Marshmallow mucilage 3,00
Dipotassium glycirrhizinate 0,40
PVM/MA 0,30
Carboxymethyl beta-glucan and Phosphoglucan 0,17

Intervention code [1] 286921 0
Prevention
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 289301 0
The aim of this study is to compare the effectiveness of these drugs in alleviating POST(postoperative sore throat) using different approaches: spraying into the oral cavity, gargling or perioperative administration of lozenges. The scale is asked to the patient. The severity of postoperative sore throat (POST) was graded on a four point scale.
as follows: 0, no sore throat;1, mild sore throat(complains of sore throat only on asking);2, moderate sore throat(complains of sore throat on his own);3, severe sore throat(change of voice associated with throat pain.
Timepoint [1] 289301 0
Postoperative sore throat were evaluated by the anesthetist in charge of the post-anesthesia care unit, blinded to the group allocations within 20 minutes in the recovery room(0 hour)and 1,6,24 hour after surgery
Secondary outcome [1] 302192 0
nil
Timepoint [1] 302192 0
nil

Eligibility
Key inclusion criteria
320 patients of either sex aged between 18 to 80 ASA I-III, elective patients undergoing genitourinary surgery under general anesthesia with orotracheal intubation will be recruited in the study.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of preoperative sore throat and asthma, Mallampati grade >2, known allergies to study drug, recent NSAID medication, surgical duration of >240 min, use of nasogastric tube, patients with upper respiratory track infection, patients on steroid therapy and those who requires more than one attempt at intubation will be excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5007 0
Turkey
State/province [1] 5007 0

Funding & Sponsors
Funding source category [1] 287070 0
Self funded/Unfunded
Name [1] 287070 0
self funded
Address [1] 287070 0
self funded
Country [1] 287070 0
Turkey
Primary sponsor type
Individual
Name
Gozde Bumin Aydin
Address
Ahmet Taner Kislali mah. Orun Villalari 2764. sok no:7 Cayyolu Ankara
Country
Turkey
Secondary sponsor category [1] 285845 0
Individual
Name [1] 285845 0
Reyhan Polat
Address [1] 285845 0
Zirvekent Evleri, Birlik mahallesi, 448. cadde, no:18
Cankaya
Country [1] 285845 0
Turkey

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Tracheal intubation is a foremost cause of trauma to the airway mucosa, resulting in postoperative sore throat which is common, uncomfortable, distressing sequelae with reported incidence of 21-65%. Although it is a minor complication it was rated by the patients as the 8th most undesirable outcome in the postoperative period. Stomatovis mouthwash is usefull for the protection of oral mucosa, prevention of symptoms associated with stomatitis of various origins and gingivitis. It also helps lubrication and moisture of the oral cavity. Strefen, a sugar-based lozenge formulation that contains the nonsteroidal anti-inflammatory drug flurbiprofen was developed to provide soothing topical effects in addition to the pain relief conferred by the systemic analgesic drug also can be administered for sore throat. Siccoral is long acting mouth and throat moisturizer contaning sea salt and glycerine. It moisturize mouth and throat mucous by its osmotic effect, provides sliminess in mouth like saliva, prevents risk of irritation and infections due to dryness.
The aim of this study is to compare the effectiveness of these drugs in alleviating postoperative sore throat (POST) using different approaches: spraying into the oral cavity, gargling or perioperative administration of lozenges.
The study is approved by the institutional ethics commitee and performed at Diskapi Yildirim Beyazit Education and Research Hospital. 320 patients of either sex aged between 18 to 80 ASA I-III, elective patients undergoing genitouriner surgery under general anesthesia with orotracheal intubation will be recruited in the study. The study is conducted in a prospective randomized, controlled and single blinded manner. Patients with a history of preoperative sore throat and asthma, Mallampati grade >2, known allergies to study drug, recent NSAID medication, surgical duration of >240 min, use of nasogastric tube, patients with upper respiratory track infection, patients on steroid therapy and those who requires more than one attempt at intubation will be excluded from the study. It will take 2 months to complete this study.
- Strefen group(STR): Flurbiprofen 8.75 mg. Sucrose, Glucose Syrup, Honey, Macrogol 300, Lemon Flavour, Potassium Hydroxide, Levomenthol. Reckitt Benckiser Healthcare, UK; strefen pastil will be applied 45 minutes before induction of anesthesia.

- Siccoral group(SCR): 10 mg sea salt % 1, glyserol, patent blue, methyl paraben, prophyl paraben, purified water. Drossapharm,Basel, Switzerland; siccoral will be sprayed into the oropharyngeal cavity 4 puffs, 1minute before induction of anesthesia.

-Stomatovis group(STM): Purified water, xylitol, marshmallow mucilage, vegetable glycerol, dipotassium glycyrrhizinate, phosphoglucan, carboximethyl beta-glucan, sodium bicarbonate, chlorobutanol, PVM/MA, sodium hydroxymethyl glycinate, PEG-40 hydrogenated castor oil , acesulfame K, flavouring, green color (E102, E131, E514).Roma,Italy: stomatovis 15-20 ml will be gargled by the patient for at least 60 seconds before induction of anesthesia.

-Control group(C): control group.
Tracheal intubation will be performed by an experienced anaesthesiologist who wis blinded to group allocation after ensuring maximum neuromuscular blocking effect as assessed by TOF guard. A train of four<10% is used as an indication of satisfactory neuromuscular blocakade for intubation. All patients will receive i.v. acetaminofen 1000 gr 30 minutes after tracheal intubation.
Postoperative sore throat will be evaluated by the anesthetist in charge of the post-anesthesia care unit, blinded to the group allocations within 20 minutes in the recovery room(0 hour)and 1,6,24 hour after surgery. At the time of the first evaluation, patients with a Ramsey Sedation Score* of 2 (cooperative, oriented and tranquil) or 3 ( responding to commonds only) will be included. The severity of postoperative sore throat (POST) is graded on a four point scale
as follows: 0, no sore throat;1, mild sore throat(complains of sore throat only on asking);2, moderate sore throat(complains of sore throat on his own);3, severe sore throat(change of voice associated with throat pain
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39174 0
Dr Gozde Bumin Aydin
Address 39174 0
Ahmet Taner Kislali Mah. Orun Villalari 2764. sok No:7 Cayyolu
Diskapi Yildirim Beyazit Education and Reasearch Hospital
Country 39174 0
Turkey
Phone 39174 0
+90-532-6453235
Fax 39174 0
Email 39174 0
drgozdeaydin@yahoo.com
Contact person for public queries
Name 39175 0
Dr Gozde Bumin Aydin
Address 39175 0
Ahmet Taner Kislali Mah. Orun Villalari 2764. sok No:7 Cayyolu
Diskapi Yildirim Beyazit Education and Reasearch Hospital
Country 39175 0
Turkey
Phone 39175 0
+90-532-6453235
Fax 39175 0
Email 39175 0
drgozdeaydin@yahoo.com
Contact person for scientific queries
Name 39176 0
Dr Gozde Bumin Aydin
Address 39176 0
Ahmet Taner Kislali Mah. Orun Villalari 2764. sok No:7 Cayyolu
Diskapi Yildirim Beyazit Education and Reasearch Hospital
Country 39176 0
Turkey
Phone 39176 0
+90-532-6453235
Fax 39176 0
Email 39176 0
drgozdeaydin@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary