Recovery Following Desflurane Versus Sevoflurane for Outpatient Urologic Surgery in Elderly Females

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Michael Green, DO, Hahnemann University Hospital
ClinicalTrials.gov Identifier:
NCT01310582
First received: March 7, 2011
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

Numerous studies demonstrate that patients have improved immediate recovery characteristics following desflurane anesthesia compared to other volatile agents, including sevoflurane. There is limited evidence in the literature to suggest that patients undergoing sevoflurane, compared to desflurane anesthesia, may suffer from limitation in function and cognitive ability for an undetermined, but prolonged period of time following surgery. These differences are not explained pharmacokinetically and may be a result of a direct neurotoxic effect of sevoflurane. An unresolved question is the time required for the ability to return to complex tasks, such as driving, following anesthesia. Commonly, patients are advised not to drive or make important decisions for 24 hours following anesthesia, but this is not well-studied and proscribed on an empiric, rather than scientific, basis with very limited data available.This study will better define recovery characteristics and characterize the severity and duration of cognitive impairment following sevoflurane or desflurane anesthesia after brief outpatient urologic surgery in elderly females using tests of cognitive ability coupled with performance on a driving simulator and cognitive task tests to objectively measure not only testing performance, but also cognitive effort in performing these tests.


Condition Intervention Phase
Ureteral Stent Occlusion
Exposure Laser
Ureterostomy; Functional Disturbance
Vaginal Diseases
Injury of Bladder
Excessive Repair
Calculi
Drug: Desflurane
Drug: Sevoflurane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Recovery Following Desflurane vs Sevoflurane for Outpatient Urologic Surgery in Elderly Females

Resource links provided by NLM:


Further study details as provided by Hahnemann University Hospital:

Primary Outcome Measures:
  • Time to Opening of Eyes [ Time Frame: At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Discharge From PACU [ Time Frame: At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery and transfer to PACU ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: May 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Desflurane
During the surgery the subjects were given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form was inhalation gas, dosage equivalent to 1 MAC, frequency was once and the duration was throughout the surgery (30-45 minutes).
Drug: Desflurane
Active Comparator: Sevoflurane
During the surgery the subjects were given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form was inhalation gas, dosage equivalent to 1 MAC, frequency was once and the duration was throughout the surgery (30-45 minutes).
Drug: Sevoflurane

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • > 65 years old, female subjects
  • Scheduled for brief urologic surgery (Cyctoscopy, Ureteral stent, Laserlithotripsy, Ureteroscopy, Vaginal sling, Bladder injury repair, Rectocele repair and Stone extraction)
  • Ability to read, write and speak English language
  • Driving at least one year

Exclusion Criteria:

  • Preexisting neurological impairment in thinking process
  • Renal insufficiency or failure
  • Lack of command of English language
  • Inability to drive
  • Motion Sickness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310582

Locations
United States, Pennsylvania
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Hahnemann University Hospital
Baxter Healthcare Corporation
Investigators
Principal Investigator: George Mychaskiw, DO Professor and Chair, Department of Anesthesiology
  More Information

No publications provided

Responsible Party: Michael Green, DO, Assistant Professor, Hahnemann University Hospital
ClinicalTrials.gov Identifier: NCT01310582     History of Changes
Other Study ID Numbers: 19326
Study First Received: March 7, 2011
Results First Received: August 19, 2013
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hahnemann University Hospital:
Sevoflurane
Desflurane

Additional relevant MeSH terms:
Calculi
Vaginal Diseases
Keloid
Wounds and Injuries
Pathological Conditions, Anatomical
Genital Diseases, Female
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
Desflurane
Sevoflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on July 26, 2014