The Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery

Anesthesia Clinical Trial

Official title:

Investigation of the Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04819659
• Other study ID #: 2020/1421
• Secondary ID: E-29624016-050.9
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: April 14, 2022

Study information

• Verified date: April 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pharyngeal packing is a frequently used application to reduce the incidence and severity of postoperative nausea and vomiting (PONV) in patients who undergo nasal surgery. This study aims to research the effects of PP on gastric antral cross-sectional area (ACSA) and hence gastric volume as assessed by ultrasound, therewithal PONV and sore throat were evaluated as secondary outcomes in rhino logic surgeries (Septorhinoplasty, Septoplasty, Functional endoscopic sinus surgery).

Description:

Postoperative nausea and vomiting (PONV) after nasal surgery (Septorhinoplasty, Septoplasty, Functional endoscopic sinus surgery) is a very common complication (34-60%). Therefore, pharangeal packing was performed to prevent blood ingestion so as to decrease the incidence of PONV and the risk of aspiration. Also, gastric blood is known to be a powerful emetic. Actually, there is not any evidence in the literature reporting the quantitative values of gastric volumes due to blood ingestion. The aim of this study is to research the effect of pharyngeal packing on the perioperative gastric antral cross-sectional area (ACSA) so the gastric volumes. Measurements were performed by ultrasound with convex probe in right lateral decubitus position, in order to evaluate the effectiveness of pharyngeal packing in patients undergoing nasal surgery, and to show its effects on PONV and sore throat.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 14, 2022
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• undergoing elective nasal or paranasal sinus surgery following overnight fasting
• 18-70 years of age
• accepting to join the study
• American Society of Anesthesiologist (ASA) classification system I-III
• Body mass Index (BMI) < 30 kg/m2

Exclusion Criteria:

• ASA classification higher than III
• Age younger than 18 years
• BMI>30 kg/m2
• Preoperative vomiting or antiemetic medication therapy
• Intubation needing more than two laryngoscopy attempts
• Not agreeing to participate in the study
• Coagulation disorders
• Diseases or conditions affecting gastric volume or motility

Related Conditions & MeSH terms

• Anesthesia
• Gastric Volume
• Nasal Surgery
• Pharyngeal Packing
• Postoperative Nausea
• Postoperative Nausea and Vomiting

Intervention

Device:
• Pharyngeal packing
Placing gauze-like material in the nasal cavity to absorb blood or other fluids right after tracheal intubation.

Locations

Country	Name	City	State
Turkey	Istanbul University, Department of Anesthesiology	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Temel ME, Totoz T, Erkalp K, Temel GS, Selcan A. A randomized, double-blind study of the ultrasound assessment of the effect of pharyngeal packing on perioperative gastric volume in nasal surgery. BMC Anesthesiol. 2019 Jul 8;19(1):121. doi: 10.1186/s12871-019-0786-7. — View Citation

Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, Langer C, Murphy B, Cumberlin R, Coleman CN, Rubin P. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 2003 Jul;13(3):176-81. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The crosssectional area (ACSA) (Postoperative) (mm2) (Postoperative)	measurements are done with USG and calculated with this formula CSA = (AP (anterior-posterior) diameter × CC (cranio-caudal) diameter× 3.14) / 4.	10 minutes before extubation
Secondary	Postoperative presence and severity of PONV	The severity of PONV was assessed according to the four points score: None (0 point), nausea (1 point), nausea with maximum of two vomiting episodes (2 points), more than two vomiting episodes (3 points).; When PONV with = 2 points metaclopropamid 10 mg was done, and in order to repetition granisetron 3 mg was added.	at the first, second and 24th hours in PACU and at the ward
Secondary	The severity of sore throat	No pain (0 point), mild pain (1 point), moderate pain (2 points) and severe pain (3 points). Patients with severe sore throat were given paracetamol.	at the first, second and 24th hours in PACU and at the ward
Secondary	Blood volume in the suction system	weighing sponge, pad, compress and blood volume in the aspirator	in the perioperative period