Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000972820
Ethics application status
Approved
Date submitted
30/07/2020
Date registered
26/07/2021
Date last updated
26/07/2021
Date data sharing statement initially provided
26/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Postoperative sore throat, cough and hoarseness in patients undergoing lower abdominal surgery
Scientific title
Effects of desflurane and sevoflurane on postoperative sore throat, cough and hoarseness in patients undergoing lower abdominal surgery
Secondary ID [1] 301767 0
None
Universal Trial Number (UTN)
U1111-1255-2613
Trial acronym
PSTCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower abdominal surgery 318234 0
Condition category
Condition code
Anaesthesiology 316243 316243 0 0
Anaesthetics
Surgery 316244 316244 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will be monitorized with electrocardiography, noninvasive arterial blood pressure, peripheral oxygen saturation, and end-tidal carbon dioxide immediately after taken to operation table. Anaesthetic administration will be recorded in patient medical record.
In order to provide postoperative analgesia to all patients, an epidural catheter will be placed at level of L3-4 10 minutes prior to induction of general anesthesia.
In induction, propofol 1.5-2.5 mg / kg, rocuronium 0.6 mg / kg and fentanyl 1µg / kg will be given intravenously. After sufficient muscle relaxation, female patients will be intubated with a low pressure-high volume cuffed 7.5 mm endotracheal tube male patients with 8.0 mm. The tube cuff will be inflated with air to be 20 mmHg (26 cm H2O), and the tube cuff pressure will be measured every 30 minutes during the operation and its pressure will be maintained at 20 mmHg. Dexametazone 4 mg and paracetamol 1 g iv infusion (15-20min) will be given. Nasogastric tube and airway application will be avoided in patients and patients who have to be applied will be excluded from the study.
Patients will be randomly divided into 2 groups according to the inhalational anesthetic agent used in the maintenance of anesthesia. In Group S sevoflurane %1.5-2 and in Group D desflurane %4-6 with air-oxigen mixture. When necessary fentanyl 0.5 µg / kg intravenously and rocuronium 0.1 mg / kg intravenously will be added. 15 minutes before the end of operation ondansetron 4 mg intravenously and 0.125% bubivacaine + 2 µg fentanyl (30 mL 0.5% bupivacaine + 5 mL fentanyl + 85 mL SF with a speed 5ml/hour) via the epidural catheter.
At the end of the operation, neuromuscular block will be antagonized with 50 µg / kg neostigmine and 0.02 mg / kg atropine. When a sufficient tidal volume (4 mL / kg) and have an eye-opening response to the oral stimulus patients will be extubated, and the duration of surgery and anesthesia will be recorded. Tramadol 0.5 mg / kg intravenously will be given as rescue analgesic.
1, 3, 6, 12, 24 and 72 hours after the operation patients will be questioned about sore throat, cough and hoarseness by a researcher who is blind to the groups. Four-scale survey will be used in the inquiry (0 = None, 1 = Mild, 2 = Medium, 3 = Severe).
Intervention code [1] 318078 0
Treatment: Drugs
Intervention code [2] 318079 0
Prevention
Comparator / control treatment
Patients will be randomly divided into 2 groups according to the inhalational anesthetic agent used in the maintenance of anesthesia. In Group S sevoflurane %1.5-2 with air-oxygen mixture will be administered. In the the comparator group (Group D) desflurane %4-6 with air-oxygen mixture. When necessary fentanyl 0.5 µg / kg iv, rocuronium 0.1 mg / kg intravenously will be added. 15 minutes before the end of operation ondansetron 4 mg iv and 0.125% bubivacaine + 2 µg fentanyl (30 mL 0.5% bupivacaine + 5 mL fentanyl + 85 mL saline with a speed 5ml/hour) via the epidural catheter.
At the end of the operation, neuromuscular block will be antagonized with 50 µg / kg neostigmine and 0.02 mg / kg atropine. When a sufficient tidal volume (4 mL / kg) and have an eye-opening response to the oral stimulus patients will be extubated, and the duration of surgery and anesthesia will be recorded. Tramadol 0.5 mg / kg intravenously will be given as rescue analgesic.
1, 3, 6, 12, 24 and 72 hours after the operation patients will be questioned about sore throat, cough and hoarseness by a researcher who is blind to the groups
Control group
Active

Outcomes
Primary outcome [1] 324442 0
Sore throat will be assessed with 4-point Likert scale
Timepoint [1] 324442 0
Postoperative 1,3,6,12,24 (primary end point),72 hour
Secondary outcome [1] 393341 0
Cough will be assessed with 4-point Likert scale
Timepoint [1] 393341 0
Postoperative 1,3,6,12,24(secondary end point),72 hour
Secondary outcome [2] 393342 0
Hoarseness will be assessed with 4-point Likert scale
Timepoint [2] 393342 0
Postoperative 1,3,6,12,24(secondary end point),72 hour

Eligibility
Key inclusion criteria
1) Lower abdominal surgery
2) Surgery time aproximately 60-240 minutes
3) ASA-I,ASA II
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) ASA III-IV
2) With tracheostomy
3) Laryngeal illness
4) History of laryngeal surgery
5) Nasogastric tube requirement
6) Difficult intubation

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/08/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment outside Australia
Country [1] 22741 0
Turkey
State/province [1] 22741 0
Mugla

Funding & Sponsors
Funding source category [1] 306200 0
Hospital
Name [1] 306200 0
Mugla Sitki Koçman University Training and Research Hospital
Country [1] 306200 0
Turkey
Funding source category [2] 306338 0
Hospital
Name [2] 306338 0
Yeni Yüzyil Üniversitesi Özel Gaziosmanpasa Hospital
Country [2] 306338 0
Turkey
Primary sponsor type
Individual
Name
Semra Gümüs Demirbilek
Address
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country
Turkey
Secondary sponsor category [1] 306672 0
None
Name [1] 306672 0
Address [1] 306672 0
Country [1] 306672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306408 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 306408 0
Ethics committee country [1] 306408 0
Turkey
Date submitted for ethics approval [1] 306408 0
11/04/2019
Approval date [1] 306408 0
18/07/2019
Ethics approval number [1] 306408 0
2019/II

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103782 0
Prof Semra Gümüs Demirbilek
Address 103782 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 103782 0
Turkey
Phone 103782 0
+905367648718
Fax 103782 0
Email 103782 0
[email protected]
Contact person for public queries
Name 103783 0
Semra Gümüs Demirbilek
Address 103783 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 103783 0
Turkey
Phone 103783 0
+905367648718
Fax 103783 0
Email 103783 0
[email protected]
Contact person for scientific queries
Name 103784 0
Semra Gümüs Demirbilek
Address 103784 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 103784 0
Turkey
Phone 103784 0
+905367648718
Fax 103784 0
Email 103784 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication on request and ending 1 year following publication.
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
The data can be obtained by emaling the principal investigator ([email protected])


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
No additional documents have been identified.