NCT02757300

Mucosal Injury Using Pharyngeal Packing

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Marienhospital Osnabrück · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Sore Throat

Interventions

Type	Name	Description
DEVICE	Hypopharyngeal packing	After introduction and orotracheal intubation a hypopharyngeal packing soaked with Chlorhexidinbis (D-gluconat) is placed.
DEVICE	Without 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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-03-01
• Completion: 2018-07-01
• First posted: 2016-05-02
• Last updated: 2022-09-01