Mucosal Injury Using Pharyngeal Packing

Sore Throat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02757300
• Other study ID #: mho 004
• Status: Withdrawn
• Phase: N/A
• Start date: May 2016
• Est. completion date: July 2018

Study information

• Verified date: August 2022
• Source: Marienhospital Osnabrück
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pharyngitis
• Sore Throat

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marienhospital Osnabrück

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of mucosal injury	Incidence and severity of mucosal injury evaluated by NRS-Scores and a colleague of the ENT department blinded to intra-operative management	Second postoperative day