NCT01945502

Brief Summary

The purpose of this study is to assess the efficacy of three different pharyngeal packing during routine rhinologic surgery in the prevention of postoperative nausea and vomiting, and to evaluate the influence of pharyngeal packing on postoperative throat pain.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

September 18, 2013

Status Verified

September 1, 2013

Enrollment Period

3 months

First QC Date

September 16, 2013

Last Update Submit

September 16, 2013

Conditions

Outcome Measures

Primary Outcomes (2)

  • Postoperative nausea vomiting

    3 months

  • sore throat

    3 months

Study Arms (4)

nasal packing with dry packs

nasal packing with wet packs

nasal packing with Benzidamin-Clorhexsidin damped packs

no nasal packing

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Adult patients (18-60 years) scheduled for routine nasal and/or paranasal sinus surgeries in Ankara Univerity Faculty of Medicine, ETN operating rooms were recruited into this study.

You may qualify if:

  • years old adult patient
  • nasal and/or paranasal sinus surgeries
  • general anesthesia

You may not qualify if:

  • patients submitted to another intervention at the same time (adenoidectomy, tonsillectomy)
  • patients with a serious systemic disease (acquired immunodeficiency syndrome,leukemia, lymphoma, or other neoplasias under chemotherapy treatment)
  • patients presenting contraindications for using nonsteroid anti-inflammatory drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Medicine ENT operating rooms

Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, DESA

Study Record Dates

First Submitted

September 16, 2013

First Posted

September 18, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Last Updated

September 18, 2013

Record last verified: 2013-09

Locations