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AnesthesiaNCT04819659

The Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery

A study testing Pharyngeal packing in people with Anesthesia and Nasal Surgery, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pharyngeal packing is a frequently used application to reduce the incidence and severity of postoperative nausea and vomiting (PONV) in patients who undergo nasal surgery. This study aims to research the effects of PP on gastric antral cross-sectional area (ACSA) and hence gastric volume as assessed by ultrasound… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Anesthesia, Nasal Surgery, Pharyngeal Packing
What is being tested?
Pharyngeal packing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2021to 14 Apr 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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • undergoing elective nasal or paranasal sinus surgery following overnight fasting
  • 18-70 years of age
  • accepting to join the study
  • American Society of Anesthesiologist (ASA) classification system I-III
  • Body mass Index (BMI) < 30 kg/m2

Who cannot join

  • ASA classification higher than III
  • Age younger than 18 years
  • BMI>30 kg/m2
  • Preoperative vomiting or antiemetic medication therapy
  • Intubation needing more than two laryngoscopy attempts
  • Not agreeing to participate in the study
  • Coagulation disorders
  • Diseases or conditions affecting gastric volume or motility

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul University, Department of Anesthesiology

    Istanbul, Fatih, 34093

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery

Pharyngeal packing is a frequently used application to reduce the incidence and severity of postoperative nausea and vomiting (PONV) in patients who undergo nasal surgery. This study aims to research the effects of PP on gastric antral cross-sectional area (ACSA) and hence gastric volume as assessed by ultrasound, therewithal PONV and sore throat were evaluated as secondary outcomes in rhino logic surgeries (Septorhinoplasty, Septoplasty, Functional endoscopic sinus surgery).

Read the detailed description

Postoperative nausea and vomiting (PONV) after nasal surgery (Septorhinoplasty, Septoplasty, Functional endoscopic sinus surgery) is a very common complication (34-60%). Therefore, pharangeal packing was performed to prevent blood ingestion so as to decrease the incidence of PONV and the risk of aspiration. Also, gastric blood is known to be a powerful emetic. Actually, there is not any evidence in the literature reporting the quantitative values of gastric volumes due to blood ingestion. The aim of this study is to research the effect of pharyngeal packing on the perioperative gastric antral cross-sectional area (ACSA) so the gastric volumes.

Measurements were performed by ultrasound with convex probe in right lateral decubitus position, in order to evaluate the effectiveness of pharyngeal packing in patients undergoing nasal surgery, and to show its effects on PONV and sore throat.

Being tested
Pharyngeal packing
Medical subject headings
Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharyngeal packingDevice

    Placing gauze-like material in the nasal cavity to absorb blood or other fluids right after tracheal intubation.

Study groups in NCT04819659
Study groupRoleWhat they receive
Group ControlNo interventionWithout pharyngeal pack insertion
Group Pharyngeal packing (Group PP)ExperimentalPharyngeal pack insertion after endotracheal intubation
Receives: Device: Pharyngeal packing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The crosssectional area (ACSA) (Postoperative) (mm2) (Postoperative)

    measurements are done with USG and calculated with this formula CSA = (AP (anterior-posterior) diameter × CC (cranio-caudal) diameter× 3.14) / 4.

    Measured: 10 minutes before extubation

Secondary outcomes (3)

  1. Postoperative presence and severity of PONV

    The severity of PONV was assessed according to the four points score: None (0 point), nausea (1 point), nausea with maximum of two vomiting episodes (2 points), more than two vomiting episodes (3 points).

    When PONV with ≥ 2 points metaclopropamid 10 mg was done, and in order to repetition granisetron 3 mg was added.

    Measured: at the first, second and 24th hours in PACU and at the ward

  2. The severity of sore throat

    No pain (0 point), mild pain (1 point), moderate pain (2 points) and severe pain (3 points). Patients with severe sore throat were given paracetamol.

    Measured: at the first, second and 24th hours in PACU and at the ward

  3. Blood volume in the suction system

    weighing sponge, pad, compress and blood volume in the aspirator

    Measured: in the perioperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start1 Jan 2021
  3. Primary completion14 Apr 2022
  4. Study completion14 Apr 2022

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04819659
Sponsor's protocol ID
2020/1421
Other IDs
E-29624016-050.99-411338
Status last verified
Apr 2022
First submitted
24 Mar 2021
Last updated
15 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Temel ME, Totoz T, Erkalp K, Temel GS, Selcan A. A randomized, double-blind study of the ultrasound assessment of the effect of pharyngeal packing on perioperative gastric volume in nasal surgery. BMC Anesthesiol. 2019 Jul 8;19(1):121. doi: 10.1186/s12871-019-0786-7.

    PubMed 31286899

  • Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, Langer C, Murphy B, Cumberlin R, Coleman CN, Rubin P. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 2003 Jul;13(3):176-81. doi: 10.1016/S1053-4296(03)00031-6.

    PubMed 12903007

Questions about this trial

What is this clinical trial studying?

A study testing Pharyngeal packing in people with Anesthesia and Nasal Surgery, run by Istanbul 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 5 inclusion and 8 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 15 Apr 2022. 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. 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?

The crosssectional area (ACSA) (Postoperative) (mm2) (Postoperative) (time frame: 10 minutes before extubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04819659, which also lists 2 linked publications.

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 15 Apr 2022.

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