Intraoperative Bleeding During Endoscopic Sinus Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous anesthesia

Intravenous anesthesia with propofol for endoscopic sinus surgery

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

100-200mcg/kg/min by infusion

Inhalation anesthesia

Inhalation anesthesia with sevoflurane for endoscopic sinus surgery

Group Type ACTIVE_COMPARATOR

sevoflurane

Intervention Type DRUG

1-3% of sevoflurane (expired)

Interventions

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propofol

100-200mcg/kg/min by infusion

Intervention Type DRUG

sevoflurane

1-3% of sevoflurane (expired)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes