Skip to main content
OpenTrials
Completed

NCT Number: NCT04819659

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia Gastric Volume Nasal Surgery Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Packing Postoperative Complications Postoperative Nausea Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Department of Anesthesiology

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharyngeal packing

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Blood volume in the suction system

    Time frame: in the perioperative period

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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2021
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.