POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

Incidence of Postoperative Cognitive Dysfunction in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia: A Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199913
• Other study ID #: 5100193
• Status: Completed
• Phase: N/A
• First received: September 9, 2010
• Last updated: September 8, 2014
• Start date: August 2010
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Postoperative Cognitive Dysfunction

Intervention

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.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia	The primary outcome measure will be changes in cognitive function after anesthesia as measured by MMSE.	Both groups will complete the MMSE at 1, 6, and 24 hours after the end of anesthesia or to disharge up to 7 days.	No
Secondary	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.		24 hours to 7 days	No