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POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01199913
First Posted: September 13, 2010
Last Update Posted: September 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Richard Applegate, Loma Linda University
September 9, 2010
September 13, 2010
September 9, 2014
August 2010
August 2014   (Final data collection date for primary outcome measure)
POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia [ Time Frame: Both groups will complete the MMSE at 1, 6, and 24 hours after the end of anesthesia or to disharge up to 7 days. ]
The primary outcome measure will be changes in cognitive function after anesthesia as measured by MMSE.
The primary outcome measure will be changes in cognitive function after anesthesia as measured by MMSE. [ Time Frame: . Both groups will complete the MMSE at 1, 6, and 24 hours after the end of anesthesia or to disharge up to 7 days. ]
Complete list of historical versions of study NCT01199913 on ClinicalTrials.gov Archive Site
Secondary outcome measures will include: 1) time to extubation, anesthetic complications (e.g. coughing during extubation), 2) time to readiness for discharge from PACU, 3) length of hospital stay, and 4) any postoperative complications. [ Time Frame: 24 hours to 7 days ]
Same as current
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POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia
Incidence of Postoperative Cognitive Dysfunction in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia: A Randomized, Controlled Trial
The use of desflurane in elderly subjects (>65 years old) undergoing general anesthesia with endotracheal intubation will result in decreased POCD compared to sevoflurane if the patient's MAP is within 20% of the patient's baseline and the cerebral suppression state index stays within the moderately anesthetized range during general anesthesia.
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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
Adult patients, male and female, 65 years or older scheduled for elective surgery requiring general anesthesia.
1. Postoperative Cognitive Dysfunction
Other: The intervention will be Mini-Mental Status Examination (MMSE)
A questionnaire given to the study patient before and after the anesthetic at 1, 6 and 24 hours.
desflurane and sevoflurane
Subjects will be randomized to either desflurane or sevoflurane. They will be given the Mini Mental State exam at 1, 6 and 24 hours after the end of anesthesia.
Intervention: Other: The intervention will be Mini-Mental Status Examination (MMSE)
Meineke M, Applegate RL 2nd, Rasmussen T, Anderson D, Azer S, Mehdizadeh A, Kim A, Allard M. Cognitive dysfunction following desflurane versus sevoflurane general anesthesia in elderly patients: a randomized controlled trial. Med Gas Res. 2014 Mar 25;4(1):6. doi: 10.1186/2045-9912-4-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
August 2014
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients (>65 years old)
  • Scheduled for elective surgery requiring general anesthesia at LLUMC HSH
  • Airway management expected to include endotracheal intubation
  • Expected surgical duration 120 to 240 minutes

Exclusion Criteria:

  • Pre-existing significant psychiatric disease or mental status changes
  • Clinically significant cardiovascular, respiratory, hepatic, renal,neurological, psychiatric, or metabolic disease
  • Patient's weighing >50% ideal body weight

    • Men: Ideal Body Weight (in kilograms) = 50 + 2.3 kg per inch over 5 feet
    • Women: Ideal Body Weight (in kilograms) = 45.5 + 2.3kg per inch over 5 feet
  • Patients who have undergone a general anesthetic within the past 7 days
  • Patient refusal
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01199913
5100193
No
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Richard Applegate, Loma Linda University
Loma Linda University
Not Provided
Not Provided
Loma Linda University
September 2014