NCT04819659

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2022

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

March 24, 2021

Last Update Submit

April 14, 2022

Conditions

AnesthesiaNasal SurgeryPharyngeal PackingGastric VolumePostoperative Nausea

Outcome Measures

Primary Outcomes (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.

    10 minutes before extubation

Secondary Outcomes (3)

  • Postoperative presence and severity of PONV

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

  • The severity of sore throat

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

  • Blood volume in the suction system

    in the perioperative period

Study Arms (2)

Group Control

NO INTERVENTION

Without pharyngeal pack insertion

Group Pharyngeal packing (Group PP)

EXPERIMENTAL

Pharyngeal pack insertion after endotracheal intubation

Device: Pharyngeal packing

Interventions

Pharyngeal packingDEVICE

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

Group Pharyngeal packing (Group PP)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 31286899BACKGROUND

  • 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.

    PMID: 12903007BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • Demet Altun, Assoc. Prof.

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 29, 2021

Study Start

January 1, 2021

Primary Completion

April 14, 2022

Study Completion

April 14, 2022

Last Updated

April 15, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)