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Mucosal Injury Using Pharyngeal Packing

Incidence of Mucosal Injury Using Pharyngeal Packing in Surgery of the Nasal Sinuses

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02757300
Enrollment
0
Registered
2016-05-02
Start date
2016-05-31
Completion date
2018-07-31
Last updated
2022-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sore Throat

Brief summary

After approval of the Institutional Review Board and written patient´s informed consent patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups. After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay.

Detailed description

Aim of the study Post-operative nausea and vomiting (PONV) is a complication of anaesthesia and responsible for malaise of surgical patients. Furthermore, PONV has been shown causing additive costs due to anti-emetic drugs and prolonged hospitalisation. The occurrence of PONV is multifactorial. Beside individual patients factors, opioid use and type of surgery seem to be responsible for occurrence of PONV. Especially, sinus surgery carries a high risk of PONV. Blood from the operation site entering the stomach has been discussed the potential cause for PONV in this specific patient population. Therefore, hypopharyngeal packing following orotracheal intubation is a common clinical practice to prevent blood passing through the esophagus and so to lower the incidence of PONV. Unfortunately, there are limited data data supporting the effectiveness of this procedure. In contrast, some references suggest that hypopharyngeal packing may be associated with postoperative mucosal injury and sore throat with high impact on patients´ well-being. To evaluate the usefulness and safety of hypopharyngeal packing the investigators perform prospective randomized study with the following objective: 1\. Does pharyngeal packing during sinus surgery increase the incidence of mucosal injury?

Interventions

DEVICEHypopharyngeal packing

After introduction and orotracheal intubation a hypopharyngeal packing soaked with Chlorhexidinbis (D-gluconat) is placed.

DEVICEWithout Hypopharyngeal packing

After introduction and orotracheal intubation the patient will pass the operation without hypopharyngeal packing with a short tip coming out the mouth to imitate a packing.

Sponsors

Marienhospital Osnabrück
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Surgery of the sinuses * Patients over 18 years of age * Duration of surgery \> 1h

Exclusion criteria

* Refusal of the patient * Patients under 18 years of age * Chemotherapy with antiemetic medication * Combined surgery (for example tonsillectomie and sinus surgery) * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Incidence and severity of mucosal injurySecond postoperative dayIncidence and severity of mucosal injury evaluated by NRS-Scores and a colleague of the ENT department blinded to intra-operative management

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026