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Early Cognitive Function in Elderly Patients After Laser Laryngeal Surgery: Des vs Prop (POCDLLS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03194074
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Xia Shen, Eye & ENT Hospital of Fudan University

Brief Summary:
Postoperative cognitive impairment is one of the most common complications in elderly surgical patients. Laser laryngeal surgery is a short procedure, but characterized by high risk of disastrous airway fire. So the recommended oxygen concentration is less than 30%. For elderly patients, because of preoperatively declined cardiovascular and lung function and cognitive function, there is a potential that intraoperative low oxygen concentration may lead to drop of arterial oxygen tension, decrease of brain oxygenation, and exacerbate brain function impairment. Intravenous anesthesia and inhalation anesthesia is two commonly used technique for general anesthesia. Consequently, we carry out this study to identify whether different classes of anesthetics can affect postoperative cognitive function in old patient undergoing laser laryngeal surgery.

Condition or disease Intervention/treatment Phase
Cognition Disorders in Old Age Drug: Propofol Drug: Desflurane Phase 4

Detailed Description:

The allocation sequence is generated by computer random number generation, and the allocation is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The treating clinicians are not blinded to the assignment group, but all other staff involved in both the collection and collation of data, and administration of neurocognitive testing, are blinded to group allocation

The primary measurement is the MMS scores. The secondary measurements are intraoperative desaturation score (multiplying Spo2 < 90% by time (seconds)), extubation time, orientation time, and time to discharge from the post-anaesthesia care unit (PACU).

A sample size of 35 was determined by using a power analysis based on the assumptions that the incidence of postoperative cognitive impairment in adult after otorhinolaryngological surgery would be as high as 50 %, b) a 70% reduction (from 50% to 15%) would be of clinical significance, and c) α= 0.05, β= 0.2.

The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description.

The outcome of interest is cognitive decline. A Generalized estimating equation (GEE) model with compound symmetry covariance structure was constructed to compare differences between two treatments with different time points as the repeated factors. As the effect of treatments may vary across different time points, an interaction between treatments and time was included in the model. Bonferroni-corrected post hoc test was conducted to adjust the observed significant level for multiple comparisons if the null hypothesis was rejected.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Early Cognitive Function and Recovery in Elderly Patients After Laser Laryngeal Surgery: Desflurane-based vs Propofol-based Anesthesia
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: propofol group
Propofol/remifentanil-based general anesthesia.
Drug: Propofol
In propofol/remifentanil group, propofol at a rate 75~150 µg/kg/min and remifentanil at 0.1-0.3 µg/kg/min are maintained throughout surgery.
Other Name: Propofol injection from AstraZeneca

Experimental: desflurane group
Desflurane/remifentanil-based general anesthesia.
Drug: Desflurane
In desflurane/remifentanil group, desflurane at end tidal concentration at 0.7~1.0 minimum alveolar concentration (MAC) and remifentanil 0.1-0.3 ug/kg/min are used.
Other Name: Suprane from Baxter




Primary Outcome Measures :
  1. Change of Mini-Mental State (MMS) test score [ Time Frame: Change of MMS score between two time points (the day before surgery and 30min postoperatively ]
    Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery


Secondary Outcome Measures :
  1. Change of Mini-Mental State (MMS) test score [ Time Frame: Change of MMS score between two time points (the day before surgery and 1h postoperatively ]
    Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery

  2. Change of Mini-Mental State (MMS) test score [ Time Frame: Change of MMS score between two time points (the day before surgery and 3h postoperatively ]
    Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery

  3. Change of Mini-Mental State (MMS) test score [ Time Frame: Change of MMS score between two time points (the day before surgery and 24h postoperatively ]
    Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for laser laryngeal surgery under general anesthesia with either Propofol or desflurane based technique.

Exclusion Criteria:

  • Patients with cardiac, pulmonary, hepatic, or renal dysfunction, epilepsy, or uncontrolled hypertension, or those taking medications that influence the central nervous system, are excluded from the study. Patients who show obvious alteration of mental status, or refuse to participate, are also excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194074


Contacts
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Contact: Xia Shen, M.D. 8613611874118 zlsx@yahoo.com
Contact: Hui Qiao, M.D. 8615900598163 theyellow@163.com

Locations
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China, Shanghai
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China Recruiting
Shanghai, Shanghai, China, 200031
Contact: Huawei Li, Phd &MD       hwli@shmu.edu.cn   
Contact: Lingjie Wu, MS &MD       wulingjie116@163.com   
Sponsors and Collaborators
Eye & ENT Hospital of Fudan University
Investigators
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Principal Investigator: Xia Shen, M.D. Eye and ENT Hospital of Fudan University

Publications:
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Responsible Party: Xia Shen, Vise Director of Department of Anesthesiology, Eye & ENT Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03194074    
Other Study ID Numbers: POCD-DesProp
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Xia Shen, Eye & ENT Hospital of Fudan University:
Laser Laryngeal Surgery
Desflurane
Propofol
Additional relevant MeSH terms:
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Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Remifentanil
Propofol
Desflurane
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Inhalation