Mucosal Injury Using Pharyngeal Packing

Not Applicable

Withdrawn

• Conditions: Sore Throat
• Interventions: Device: Without Hypopharyngeal packing; Device: Hypopharyngeal packing

• Registration Number: NCT02757300
• Lead Sponsor: Marienhospital Osnabrück

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?

Study Timeline

• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-29
• Study Start: 2016-05
• Study First Posted: 2016-05-02
• Primary Completion: 2017-03
• Study Completion: 2018-07
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without hypopharyngeal packing	Without Hypopharyngeal packing	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.
Hypopharyngeal packing	Hypopharyngeal packing	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.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of mucosal injury	Second postoperative day	Incidence and severity of mucosal injury evaluated by NRS-Scores and a colleague of the ENT department blinded to intra-operative management