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Clinical Trials/NCT01184638
NCT01184638UnknownPhase 4

Long-term Outcome Followed-up of the Cognitive Disorders After General Anesthesia

Nanjing Medical University1 site in 1 country10,000 target enrollmentStarted: August 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Sponsor
Enrollment
10,000
Locations
1
Primary Endpoint
Cognitive ability

Study Overview

Brief Summary

Cognitive disorders in patients underwent general anesthesia are discussed for decades, but whether there were precise relationship between general anesthesia and dysgnosia is yet to be guaranteed. Although controversial data reported from experimental studies in animals, the investigators still proposed that general anesthetics could impair the normally organized system of the central nervous system, which finally displayed a dysfunction of cognition after general anesthesia in a short- or long-term period. Therefore, different types of general anesthetics such as inhalational anesthetics and intravenous anesthetics, the investigators hypothesized, had a long-term influence on patients' cognitive ability.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
10 Years to 80 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with informed consents
  • Without basal disorders of neurology and psychiatrics

Exclusion Criteria

  • With the history of cognitive disorders
  • With chronic neurological disorders
  • Cannot communicate with investigators
  • Cannot stand general anesthesia

Arms & Interventions

Inhalational anesthesia

Active Comparator

Patients received sevoflurane anesthesia during general anesthesia

Intervention: Sevoflurane (Drug)

Intravenous anesthesia

Active Comparator

Patients received intravenous anesthetic (Propofol) during general anesthesia

Intervention: Propofol (Drug)

Outcomes

Primary Outcomes

Cognitive ability

Time Frame: The 10th year since postoperation

Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory

Secondary Outcomes

  • Cognitive ability(Once a year from the 1st year after operation up to 9th year)

Investigators

Sponsor
Nanjing Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fu Zhou Wang

Dr

Nanjing Medical University

Study Sites (1)

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