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

Primary Purpose

Anesthesia, Nasal Surgery, Pharyngeal Packing

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pharyngeal packing
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul University, Department of Anesthesiology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group Control

Group Pharyngeal packing (Group PP)

Arm Description

Without pharyngeal pack insertion

Pharyngeal pack insertion after endotracheal intubation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Blood volume in the suction system
weighing sponge, pad, compress and blood volume in the aspirator

Full Information

First Posted
March 24, 2021
Last Updated
April 14, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04819659
Brief Title
The Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery
Official Title
Investigation of the Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 14, 2022 (Actual)
Study Completion Date
April 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Nasal Surgery, Pharyngeal Packing, Gastric Volume, Postoperative Nausea

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Control
Arm Type
No Intervention
Arm Description
Without pharyngeal pack insertion
Arm Title
Group Pharyngeal packing (Group PP)
Arm Type
Experimental
Arm Description
Pharyngeal pack insertion after endotracheal intubation
Intervention Type
Device
Intervention Name(s)
Pharyngeal packing
Intervention Description
Placing gauze-like material in the nasal cavity to absorb blood or other fluids right after tracheal intubation.
Primary Outcome Measure Information:
Title
The crosssectional area (ACSA) (Postoperative) (mm2) (Postoperative)
Description
measurements are done with USG and calculated with this formula CSA = (AP (anterior-posterior) diameter × CC (cranio-caudal) diameter× 3.14) / 4.
Time Frame
10 minutes before extubation
Secondary Outcome Measure Information:
Title
Postoperative presence and severity of PONV
Description
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.
Time Frame
at the first, second and 24th hours in PACU and at the ward
Title
The severity of sore throat
Description
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.
Time Frame
at the first, second and 24th hours in PACU and at the ward
Title
Blood volume in the suction system
Description
weighing sponge, pad, compress and blood volume in the aspirator
Time Frame
in the perioperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demet Altun, Assoc. Prof.
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University, Department of Anesthesiology
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31286899
Citation
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.
Results Reference
background
PubMed Identifier
12903007
Citation
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.
Results Reference
background

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

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