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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

Secondary ID [1]

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.

Condition category

Condition code

Anaesthesiology

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]

Prevention

Comparator / control treatment

no treatment

Control group

Active

Outcomes

Primary outcome [1]

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]

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]

nil

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/01/2013

Actual

3/01/2013

Date of last participant enrolment

Anticipated

1/03/2013

Actual

4/04/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

320

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

self funded

Address [1]

self funded

Country [1]

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]

Individual

Name [1]

Reyhan Polat

Address [1]

Zirvekent Evleri, Birlik mahallesi, 448. cadde, no:18
Cankaya

Country [1]

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

Dr Gozde Bumin Aydin

Address

Ahmet Taner Kislali Mah. Orun Villalari 2764. sok No:7 Cayyolu
Diskapi Yildirim Beyazit Education and Reasearch Hospital

Country

Turkey

Phone

+90-532-6453235

Fax

drgozdeaydin@yahoo.com

Contact person for public queries

Name

Gozde Bumin Aydin

Address

Ahmet Taner Kislali Mah. Orun Villalari 2764. sok No:7 Cayyolu
Diskapi Yildirim Beyazit Education and Reasearch Hospital

Country

Turkey

Phone

+90-532-6453235

Fax

drgozdeaydin@yahoo.com

Contact person for scientific queries

Name

Gozde Bumin Aydin

Address

Ahmet Taner Kislali Mah. Orun Villalari 2764. sok No:7 Cayyolu
Diskapi Yildirim Beyazit Education and Reasearch Hospital

Country

Turkey

Phone

+90-532-6453235

Fax

drgozdeaydin@yahoo.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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