Anesthesia Clinical Trial
Official title:
Investigation of the Effect of Pharyngeal Packing on Postoperative Gastric Volume in Patients Undergoing Nasal Surgery
Verified date | April 2022 |
Source | Istanbul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University, Department of Anesthesiology | Istanbul | Fatih |
Lead Sponsor | Collaborator |
---|---|
Istanbul University |
Turkey,
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
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 Ă— CC (cranio-caudal) diameterĂ— 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 |
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