Intraoperative Bleeding During Endoscopic Sinus Surgery

Blood Loss Clinical Trial

Official title:

Comparison of Intraoperative Bleeding During Endoscopic Sinus Surgery Between Patients Receiving Total Intravenous Anesthesia With Propofol and Patients Receiving an Inhalational Anesthetic With Sevoflurane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014728
• Other study ID #: 09-317A
• Status: Completed
• Phase: N/A
• First received: November 13, 2009
• Last updated: January 21, 2014
• Start date: November 2009
• Est. completion date: June 2012

Study information

• Verified date: January 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss
• Blood Loss, Surgical

Intervention

Drug:
• propofol
100-200mcg/kg/min by infusion
• sevoflurane
1-3% of sevoflurane (expired)

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated Blood Loss	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.	from the start of surgery to the end of surgery, up to 6 hours	No
Secondary	Anesthesiologist Numeric Rating Scale (ANRS)	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).	at the end of surgery (up to 6 hours)	No
Secondary	Surgeon's Numeric Rating Scale (SNRS)	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.	at the end of surgery (up to 6 hours)	No