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

NCT01310582 | Completed Phase 4 Results

• 1 other identifier: 19326
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ureteral Stent Occlusion; Exposure Laser; Ureterostomy; Functional Disturbance; Vaginal Diseases; Injury of Bladder; Excessive Repair; Calculi

Keywords

Sevoflurane; Desflurane

Outcome Measures

Primary Outcomes (1)

• Time to Opening of Eyes

  At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery

Secondary Outcomes (1)

• Time to Discharge From PACU

  At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery and transfer to PACU

Study Arms (2)

Desflurane

ACTIVE COMPARATOR

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

Sevoflurane

ACTIVE COMPARATOR

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

Interventions

Desflurane DRUG

Desflurane

Sevoflurane DRUG

Sevoflurane

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• Preexisting neurological impairment in thinking process
• Renal insufficiency or failure
• Lack of command of English language
• Inability to drive
• Motion Sickness

Sponsors & Collaborators

• Hahnemann University Hospital: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Vaginal Diseases; Calculi

Interventions

Desflurane; Sevoflurane

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Results Point of Contact

• Title: Kirtanaa Voralu, Associate Director Research Management
• Organization: Clinical Research Group

kirtanaa.voralu@drexelmed.edu

215-255-7878

Study Officials

• George Mychaskiw, DO

  Professor and Chair, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 8, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 24, 2013
• Results First Posted: December 24, 2013

Record last verified: 2013-11

Locations

US (1)