Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
1 other identifier
interventional
78
0 countries
N/A
Brief Summary
Functional endoscopic sinus surgery (FESS), or sinusoscopy, is a standard surgical procedure used to treat chronic rhinosinusitis and other conditions of the nasal sinuses. However, bleeding during surgery is a frequent challenge that can obstruct the surgeon's view, lengthen operative time, and increase the risk of complications. Vitamin C (ascorbic acid) supports collagen synthesis, capillary wall strength, and blood vessel integrity, which may help minimize mucosal bleeding during surgical procedures. The purpose of this randomized clinical trial is to evaluate whether administering preoperative Vitamin C reduces intraoperative bleeding, enhances surgical field visibility, and shortens operative duration in adult patients undergoing elective sinusoscopy. Participants will be randomly assigned to one of two groups:
- Vitamin C Group: Receives a standardized 500 mg dose of Vitamin C before surgery.
- Control Group: Receives standard perioperative care/placebo before surgery. Total blood loss will be recorded during surgery, surgical field clarity will be evaluated every 15 minutes using the Boezaart scale, and participants will be monitored for postoperative bleeding and potential side effects for up to 48 hours.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2026
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2026
CompletedFirst Posted
Study publicly available on registry
October 8, 2026
CompletedStudy Start
First participant enrolled
November 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
Study Completion
Last participant's last visit for all outcomes
December 1, 2027
October 8, 2026
October 1, 2026
1 year
October 4, 2026
October 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Intraoperative Blood Loss
Total intraoperative blood loss measured in milliliters (mL). Calculated as the total fluid collected in the suction canisters minus the volume of surgical irrigation fluid used, added to the volume calculated from blood-soaked gauzes (determined gravimetrically: wet gauze weight minus dry gauze weight, where 1 g = 1 mL).
Through completion of surgery, up to 2 hours
Study Arms (2)
Vitamin C Group
EXPERIMENTALPatients scheduled for elective functional endoscopic sinus surgery (FESS) receiving a standardized dose of 500 mg Vitamin C (ascorbic acid) preoperatively in addition to standard general anesthesia and monitoring.
Control Group
PLACEBO COMPARATORPatients scheduled for elective functional endoscopic sinus surgery (FESS) receiving matching placebo or standard perioperative care preoperatively in addition to standard general anesthesia and monitoring.
Interventions
Administration of a standardized dose of 500 mg Vitamin C (ascorbic acid) preoperatively prior to functional endoscopic sinus surgery (FESS).
Administration of matching placebo or standard perioperative care preoperatively prior to functional endoscopic sinus surgery (FESS).
Eligibility Criteria
You may qualify if:
- Patients scheduled for elective functional endoscopic sinus surgery (FESS / sinusoscopy)
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I or II
You may not qualify if:
- Pre-existing bleeding disorders, coagulopathy, or concurrent anticoagulant/antiplatelet therapy
- History of renal stones (nephrolithiasis) or severe renal impairment
- Pregnant or lactating females
- Current smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
October 4, 2026
First Posted
October 8, 2026
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
October 8, 2026
Record last verified: 2026-10