Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ascorbic acid
DrugAdministration of a standardized dose of 500 mg Vitamin C (ascorbic acid) preoperatively prior to functional endoscopic sinus surgery (FESS).
Placebo
Other interventionAdministration of matching placebo or standard perioperative care preoperatively prior to functional endoscopic sinus surgery (FESS).
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Vitamin C GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention
Trial outcomes
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).
Time frame
Through completion of surgery, up to 2 hoursLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: