Intraoperative Bleeding During Endoscopic Sinus Surgery

Not Applicable

Completed

• Conditions: Blood Loss
• Interventions: Drug: propofol; Drug: sevoflurane

• Registration Number: NCT01014728
• Lead Sponsor: University of Chicago

Brief Summary

The purpose of this study is to compare the blood loss during sinus surgery looking at two different types of anesthesia: either intravenous anesthesia with propofol or inhalational anesthesia with sevoflurane.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-13
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-17
• Primary Completion: 2012-03
• Study Completion: 2012-06
• Results First Submitted: 2013-11-20
• Results First Submitted QC: 2013-11-20
• Status Verified: 2014-01
• Results First Posted: 2014-01-09
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• male or female patients who are 18 years of age or older,
• ASA grade 1 (normal otherwise healthy patient),
• ASA grade 2 (patient with mild systemic disease),
• patients who have chronic sinusitis with or without nasal polyps.

Exclusion Criteria

• pregnancy,
• abnormal coagulation panel
• preoperative use of NSAIDS or ASA medications within 7 days,
• end-stage renal disease,
• allergy to any of the used medications,
• maximal body mass index over 35

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous anesthesia	propofol	Intravenous anesthesia with propofol for endoscopic sinus surgery
Inhalation anesthesia	sevoflurane	Inhalation anesthesia with sevoflurane for endoscopic sinus surgery

Primary Outcome Measures

Name	Time	Method
Estimated Blood Loss	from the start of surgery to the end of surgery, up to 6 hours	Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery and dividing by surgical time in hours.

Secondary Outcome Measures

Name	Time	Method
Anesthesiologist Numeric Rating Scale (ANRS)	at the end of surgery (up to 6 hours)	The anesthesiologist numeric rating scale is to rate the ease of the anesthesia technique ranging from 0 to 10 (10 is best, 0 is worst).
Surgeon's Numeric Rating Scale (SNRS)	at the end of surgery (up to 6 hours)	The surgeon's numeric rating scale(SNRS)is to rate the surgical conditions (mucosal bleeding and visibility) on a scale ranging from 0 to 10, with 0 defined as cadaveric conditions and 10 as severe bleeding requiring constant suction.

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States