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

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT04819659
Collaborator
(none)
180
1
2
15.4
11.7

Study Details

Study Description

Brief 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, therewithal PONV and sore throat were evaluated as secondary outcomes in rhino logic surgeries (Septorhinoplasty, Septoplasty, Functional endoscopic sinus surgery).

Condition or Disease Intervention/Treatment Phase
  • Device: Pharyngeal packing
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Investigation of the Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Apr 14, 2022
Actual Study Completion Date :
Apr 14, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The crosssectional area (ACSA) (Postoperative) (mm2) (Postoperative) [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 Outcome Measures

  1. Postoperative presence and severity of PONV [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 [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 [in the perioperative period]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University, Department of Anesthesiology Istanbul Fatih Turkey 34093

Sponsors and Collaborators

  • Istanbul University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Demet Altun, Assoc. Prof. Dr., Istanbul University
ClinicalTrials.gov Identifier:
NCT04819659
Other Study ID Numbers:
  • 2020/1421
  • E-29624016-050.99-411338
First Posted:
Mar 29, 2021
Last Update Posted:
Apr 15, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2022