Effect of local tranexamic acid plus phenylephrine versus phenylephrine on reduction of bleeding and improvement of surgical filed during functional endoscopic sinus surgery in patients with chronic rhinosinusitis

Effect of local tranexamic acid plus phenylephrine versus phenylephrine alone on reduction of bleeding and improvement of surgical filed during functional endoscopic sinus surgery in patients with chronic rhinosinusitis: a double blinded randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201212139014N15

Enrollment

Registered

2013-08-11

Start date

2013-06-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic rhinosinusitis. Chronic sinusitis

Interventions

Treatment - Drugs

Placebo

Intervention 1: 30 patients will receive three pads impregnated with tranexamic acid 5% and phenylephrine 0.5% for 10 minutes in each nasal cavity before surgery. Intervention 2: 30 patients will rece

30 patients will receive three pads impregnated with tranexamic acid 5% and phenylephrine 0.5% for 10 minutes in each nasal cavity before surgery

30 patients will receive three pads impregnated only with phenylephrine 0.5% for 10 minutes in each nasal cavity before surgery

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (a) patients with chronic rhinosinusitis with or without polyposis; (b) age of 18 to 60 years; (c) hemoglobin >10 mg/dl; (d) normal CT, BT, INR, PT, PTT. Exclusion criteria: (a) having hemorrhagic abnormality such as hemophilia; (b) thrombosis; (c) acute or chronic renal failure; (d) using heparin during 48 hours before surgery; (e) using aspirin during three days before surgery; (f) allergy to tranexamic acid; (g) cirrhosis; (h) chronic diseases such as hypertension, diabetes, and heart failure; (i) pregnancy; (j) color blind; (k) having cardiac stent; (l) having nasal tumor.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Quality of surgical field. Timepoint: 15, 30 and 45 minutes after surgery. Method of measurement: using Boezaart grading with1-5 scores.;Bleeding. Timepoint: 0.5 and one hour after surgery. Method of measurement: using blood accumulated in the suction chamber after reducing the amount of serum used for washing and measurement of nasopharyngeal pack weight and converting the blood weight into ml.	—

Secondary

Measure	Time frame
Nausea. Timepoint: 24 hours after surgery and three days later. Method of measurement: questionnaire.;Vomiting. Timepoint: 24 hours after surgery and three days later. Method of measurement: questionnaire.;Impaired color vision. Timepoint: 24 hours after surgery and three days later. Method of measurement: questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Sara Pazira

Besat Hospital

S_pazira2009@yahoo.com00

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 7, 2026