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

April 14, 2022 updated by: Demet Altun, Istanbul University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Istanbul University, Department of anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group Control
Without pharyngeal pack insertion
Experimental: Group Pharyngeal packing (Group PP)
Pharyngeal pack insertion after endotracheal intubation
Device: Pharyngeal packing
Placing gauze-like material in the nasal cavity to absorb blood or other fluids right after tracheal intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The crosssectional area (ACSA) (Postoperative) (mm2) (Postoperative)
Time Frame: 10 minutes before extubation
measurements are done with USG and calculated with this formula CSA = (AP (anterior-posterior) diameter × CC (cranio-caudal) diameter× 3.14) / 4.
10 minutes before extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative presence and severity of PONV
Time Frame: at the first, second and 24th hours in PACU and at the ward

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.
at the first, second and 24th hours in PACU and at the ward
The severity of sore throat
Time Frame: at the first, second and 24th hours in PACU and at the ward
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.
at the first, second and 24th hours in PACU and at the ward
Blood volume in the suction system
Time Frame: in the perioperative period
weighing sponge, pad, compress and blood volume in the aspirator
in the perioperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Demet Altun, Assoc. Prof., Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

April 14, 2022

Study Completion (Actual)

April 14, 2022

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/1421
  • E-29624016-050.99-411338 (Other Identifier: istanbul Faculty of Medicine Clin Res Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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