Mucosal Injury Using Pharyngeal Packing

NCT ID: NCT02757300

Last Updated: 2022-09-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-07-31

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?

Conditions

Sore Throat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Hypopharyngeal packing

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Without Hypopharyngeal packing

Intervention Type: DEVICE

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.

Interventions

Hypopharyngeal packing

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marienhospital Osnabrück

OTHER

Sponsor Role: lead

Responsible Party

Saskia Jetten

P.D. Dr. med. M. Beiderlinden

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Beiderlinden, PD

Role: STUDY_DIRECTOR

Marienhospital Osnabrück

Other Identifiers

mho 004

Identifier Type: -

Identifier Source: org_study_id