Clinical trial NCT04819659: The Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery
Official title: Investigation of the Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Nasal Surgery
Pharyngeal Packing
Gastric Volume
Postoperative Nausea
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The crosssectional area (ACSA) (Postoperative) (mm2) (Postoperative)
timeFrame: 10 minutes before extubation
Secondary outcomes:
measure: Postoperative presence and severity of PONV
timeFrame: at the first, second and 24th hours in PACU and at the ward
measure: The severity of sore throat
timeFrame: at the first, second and 24th hours in PACU and at the ward
measure: Blood volume in the suction system
timeFrame: in the perioperative period
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Department of Anesthesiology
state: Fatih
Study officials:
affiliation: Istanbul University
name: Demet Altun, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/S1053-4296(03)00031-6.