Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000487112
Ethics application status
Approved
Date submitted
2/03/2019
Date registered
25/03/2019
Date last updated
25/03/2019
Date data sharing statement initially provided
25/03/2019
Date results information initially provided
25/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pharyngeal packing on perioperative gastric volume in nasal surgery
Scientific title
Ultrasound assessment of the effect of pharyngeal packing on perioperative gastric volume in nasal surgery
Secondary ID [1] 297779 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nausea 311851 0
vomiting 312017 0
Condition category
Condition code
Anaesthesiology 310448 310448 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For each patient who will undergo nasal surgery,
In the preoperative unit, preoperative ultrasonographic examination of gastric antrum will be performed,
After intubation for general anesthesia, same anesthesiologist will place soft pharyngeal packs in oropharynx.
Pharygeal packing is an procedure of placing woven cotton gauzes in oropharnx.
After the completion of postoperative ultrasonographic evaluation, the pharyngeal packs will be removed.
In two separate sessions (before anaesthesia induction and before postoperative extubation), an experienced radiologist and ananaesthesiologist will evaluate the stomach from the antrum by abdominal ultrasonography.
All the procedures will execute in operating theatre.
Intervention code [1] 313827 0
Treatment: Other
Comparator / control treatment
Wet soft pharyngeal packs were not placed to the soft palate in patients in control group
Control group
Active

Outcomes
Primary outcome [1] 319315 0
Measure of gastric volume with abdominal ultrasonography
Three images were acquired in each session, and the mean antero-posterior (AP) and cranio-caudal (CC) diameters of the gastric antrum (in millimetres) were calculated.
Then, the antral cross-sectional area (ACSA) was calculated using the formula CSA = (AP × CC × 3.14) / 4. The total volume of the stomach was then estimated using a previously tested and validated mathematical model with the following formula: GV (in millilitres) = 27 + 14.6 × CSA (in square millimetres) – 1.28 × age.
Timepoint [1] 319315 0
Perioperative period
Primary outcome [2] 319545 0
Postoperative nausea and vomiting (PONV)
Kortilla’s scale will use for PONV;
Absence of any emetic episode and nausea: MILD PONV:
Mild nausea or one emetic episode or short-lasting (10 min) nausea of any severity triggered by an exogenous stimulus (e.g. drinking, eating or postoperative movement followed by diminished nausea and the patient’s feeling well throughout the entire observation period with no antiemetic drug requirement: MODERATE PONV
One or two emetic episodes or moderate or severe nausea without exogenous stimulus, or single requirement for antiemetic therapy more than two emetic or moderate to severe nauseous episodes requiring at least one antiemetic administration: SEVERE PONV
Timepoint [2] 319545 0
postoperative first 24 hours
Secondary outcome [1] 368625 0
Discharge from hospital
Timepoint [1] 368625 0
Postoperative second day

Eligibility
Key inclusion criteria
Patients aged > 18 years with body mass indexes < 35 kg/m2 and American Society of Anesthesiologists physical status classification I or II underwent elective NS [septoplasty, septo-rhinoplasty and functional endoscopic sinus surgery under general anaesthesia after 8 h preoperative fasting.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria were emergent need for surgery; risk of increased residual gastric volume (GV) due to pregnancy, smoking, or diabetes; upper gastrointestinal system disease; and history of oesophageal or upper gastrointestinal surgery.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2017
Date of last participant enrolment
Anticipated
Actual
1/02/2018
Date of last data collection
Anticipated
Actual
31/05/2018
Sample size
Target
120
Accrual to date
Final
88
Recruitment outside Australia
Country [1] 21323 0
Turkey
State/province [1] 21323 0
Bagcilar Training and Research Hospital

Funding & Sponsors
Funding source category [1] 302142 0
Hospital
Name [1] 302142 0
Bagcilar Training and Research Hospital
Country [1] 302142 0
Turkey
Primary sponsor type
Hospital
Name
Bagcilar Training and Research Hospital
Address
Bagcilar Research and Training Hospital
Sadik Ahmet Caddesi
No:6
34180
Bagcilar/Istanbul/Turkey
Country
Turkey
Secondary sponsor category [1] 301977 0
None
Name [1] 301977 0
Address [1] 301977 0
Country [1] 301977 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302821 0
The Bagcilar Training and Research Hospital Non-Interventional Clinical Trials Ethics Committee
Ethics committee address [1] 302821 0
Bagcilar Research and Training Hospital
Sadik Ahmet Caddesi
No:6
34180
Bagcilar/Istanbul/Turkey
Ethics committee country [1] 302821 0
Turkey
Date submitted for ethics approval [1] 302821 0
Approval date [1] 302821 0
17/03/2016
Ethics approval number [1] 302821 0

Summary
Brief summary
Pharyngeal packing (PP) is commonly performed to reduce the incidence of perioperative blood ingestion (PBI) in nasal surgery (NS), and thus the incidence and severity of postoperative nausea and vomiting (PONV). This study examined the effects of PP on the perioperative gastric volume (GV) and PONV in patients undergoing NS by ultrasound assessment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91510 0
A/Prof KEREM ERKALP
Address 91510 0
Health Sciences University,
Istanbul Bagcilar Tranind and Educational Hospital,
Department of Anesthesiology and Reanimation
Sadik Ahmet Caddesi
No:6
34180
Bagcilar/Istanbul/Turkey
Country 91510 0
Turkey
Phone 91510 0
+905327879500
Fax 91510 0
Email 91510 0
[email protected]
Contact person for public queries
Name 91511 0
A/Prof KEREM ERKALP
Address 91511 0
Health Sciences University,
Istanbul Bagcilar Tranind and Educational Hospital,
Department of Anesthesiology and Reanimation
Istanbul/Turkey
Sadik Ahmet Caddesi
No:6
34180
Bagcilar/Istanbul/Turkey
Country 91511 0
Turkey
Phone 91511 0
+905327879500
Fax 91511 0
Email 91511 0
[email protected]
Contact person for scientific queries
Name 91512 0
A/Prof KEREM ERKALP
Address 91512 0
Health Sciences University,
Istanbul Bagcilar Tranind and Educational Hospital,
Department of Anesthesiology and Reanimation
Istanbul/Turkey
Sadik Ahmet Caddesi
No:6
34180
Bagcilar/Istanbul/Turkey
Country 91512 0
Turkey
Phone 91512 0
00902124404000
Fax 91512 0
Email 91512 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA randomized, double-blind study of the ultrasound assessment of the effect of pharyngeal packing on perioperative gastric volume in nasal surgery2019https://doi.org/10.1186/s12871-019-0786-7
N.B. These documents automatically identified may not have been verified by the study sponsor.