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

NCT ID: NCT04819659

Last Updated: 2022-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-04-14

Brief Summary

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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

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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.

Conditions

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Anesthesia Nasal Surgery Pharyngeal Packing Gastric Volume Postoperative Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group Control

Without pharyngeal pack insertion

Group Type NO_INTERVENTION

No interventions assigned to this group

Group Pharyngeal packing (Group PP)

Pharyngeal pack insertion after endotracheal intubation

Group Type EXPERIMENTAL

Pharyngeal packing

Intervention Type DEVICE

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

Interventions

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Pharyngeal packing

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Demet Altun

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Demet Altun, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Locations

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Istanbul University, Department of Anesthesiology

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31286899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12903007 (View on PubMed)

Other Identifiers

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E-29624016-050.99-411338

Identifier Type: OTHER

Identifier Source: secondary_id

2020/1421

Identifier Type: -

Identifier Source: org_study_id

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