Mucosal Injury Using Pharyngeal Packing

Marienhospital Osnabrück

Status: Withdrawn

Conditions: Sore Throat

Treatments: Device: Hypopharyngeal packing; Device: Without Hypopharyngeal packing

Study type: Interventional

Funder types: Other

Identifiers

NCT02757300

mho 004

Details and patient eligibility

About

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.

Full 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?

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Hypopharyngeal packing

Experimental group

Description:

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.

Treatment:

Device: Hypopharyngeal packing

Without hypopharyngeal packing

Active Comparator group

Description:

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.

Treatment:

Device: Without Hypopharyngeal packing