Status:
COMPLETED
Comparing Desflurane to Sevoflurane for the Effect on Recovery Time in Patients Undergoing Urological Cystoscope Surgery
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Cystoscopes
Baxter Anaesthesia Brand of Desflurane
Eligibility:
All Genders
50-75 years
Phase:
PHASE3
Brief Summary
This is a single-center, prospective, randomized, double-blind, double-arm trial including 68 subjects scheduled to undergo urological cystoscope surgeries under general anesthesia (GA) with intubatio...
Detailed Description
This is a single-center, prospective, randomized, double-blind, double-arm trial including 68 subjects scheduled to undergo urological cystoscope surgeries under general anesthesia (GA) with intubatio...
Eligibility Criteria
Inclusion
- Male or female, 50 to 75 years of age.
- Subjects with an American Society of Anesthesiologist (ASA) physical status of I to III.
- Subjects able to provide written informed consent to participate in the study.
- Female subjects who have a negative urine or serum pregnancy test, who have been surgically sterilized, or are postmenopausal.
- Subjects scheduled for urological cystoscopic surgery under general anesthesia with LMA intubation.
Exclusion
- Subjects who are prisoners.
- Subjects who have limited decision-making capacity or lack the ability to consent.
- Subjects with a history of alcohol or drug abuse within the last year.
- Subjects with a history of an allergic reaction, intolerance, or contraindications to any of the study medications.
- Females who are pregnant or are breastfeeding.
- Subjects with BMI greater than 35.
- Subjects with a history of hiatal hernia or gastroesophageal reflux disease (GERD).
- Subjects with a history of pharyngeal pathology.
- Subjects who have participated in or are currently participating in a clinical trial of an investigational drug within 30 days prior to surgery.
- Subjects with a fixed decreased pulmonary compliance, such as patients with pulmonary fibrosis.
- Subjects with multiple or massive injuries, acute abdominal and/or thoracic injuries.
- Subjects with any condition associated with delayed gastric emptying.
- Subjects who are profoundly unconscious and who may not resist LMA insertion or have a contraindication for the use of LMA intubation.
- Subjects with any condition that in the opinion of the investigator would render the subject ineligible for participation in the study, such as unstable or severe cardiovascular, pulmonary, renal, hepatic, metabolic, or endocrine disease or neuromuscular disorder.
- Subjects with a history of malignant hyperthermia.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01219881
Start Date
September 1 2010
End Date
October 1 2012
Last Update
November 16 2021
Active Locations (1)
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1
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210