POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Richard Applegate, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01199913
First received: September 9, 2010
Last updated: August 27, 2013
Last verified: August 2013

September 9, 2010
August 27, 2013
September 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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01199913
5100193
No
Richard Applegate, Loma Linda University
Loma Linda University
Not Provided
Not Provided
Loma Linda University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP