Early Cognitive Function in Elderly Patients After Laser Laryngeal Surgery: Des vs Prop (POCDLLS)
Primary Purpose
Cognition Disorders in Old Age
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Propofol
Desflurane
Sponsored by
About this trial
This is an interventional supportive care trial for Cognition Disorders in Old Age focused on measuring Laser Laryngeal Surgery, Desflurane, Propofol
Eligibility 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.
Sites / Locations
- Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, ChinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
propofol group
desflurane group
Arm Description
Propofol/remifentanil-based general anesthesia.
Desflurane/remifentanil-based general anesthesia.
Outcomes
Primary Outcome Measures
Change of Mini-Mental State (MMS) test score
Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery
Secondary Outcome Measures
Change of Mini-Mental State (MMS) test score
Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery
Change of Mini-Mental State (MMS) test score
Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery
Change of Mini-Mental State (MMS) test score
Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery
Full Information
NCT ID
NCT03194074
First Posted
June 17, 2017
Last Updated
July 26, 2018
Sponsor
Eye & ENT Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT03194074
Brief Title
Early Cognitive Function in Elderly Patients After Laser Laryngeal Surgery: Des vs Prop
Acronym
POCDLLS
Official Title
Early Cognitive Function and Recovery in Elderly Patients After Laser Laryngeal Surgery: Desflurane-based vs Propofol-based Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye & ENT Hospital of Fudan University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition Disorders in Old Age
Keywords
Laser Laryngeal Surgery, Desflurane, Propofol
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
propofol group
Arm Type
Experimental
Arm Description
Propofol/remifentanil-based general anesthesia.
Arm Title
desflurane group
Arm Type
Experimental
Arm Description
Desflurane/remifentanil-based general anesthesia.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Propofol injection from AstraZeneca
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Other Intervention Name(s)
Suprane from Baxter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Mini-Mental State (MMS) test score
Description
Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery
Time Frame
Change of MMS score between two time points (the day before surgery and 30min postoperatively
Secondary Outcome Measure Information:
Title
Change of Mini-Mental State (MMS) test score
Description
Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery
Time Frame
Change of MMS score between two time points (the day before surgery and 1h postoperatively
Title
Change of Mini-Mental State (MMS) test score
Description
Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery
Time Frame
Change of MMS score between two time points (the day before surgery and 3h postoperatively
Title
Change of Mini-Mental State (MMS) test score
Description
Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery
Time Frame
Change of MMS score between two time points (the day before surgery and 24h postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xia Shen, M.D.
Phone
8613611874118
Email
zlsx@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Qiao, M.D.
Phone
8615900598163
Email
theyellow@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xia Shen, M.D.
Organizational Affiliation
Eye and ENT Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huawei Li, Phd &MD
Email
hwli@shmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Lingjie Wu, MS &MD
Email
wulingjie116@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21474666
Citation
Evered L, Scott DA, Silbert B, Maruff P. Postoperative cognitive dysfunction is independent of type of surgery and anesthetic. Anesth Analg. 2011 May;112(5):1179-85. doi: 10.1213/ANE.0b013e318215217e. Epub 2011 Apr 7.
Results Reference
background
PubMed Identifier
10624999
Citation
Larsen B, Seitz A, Larsen R. Recovery of cognitive function after remifentanil-propofol anesthesia: a comparison with desflurane and sevoflurane anesthesia. Anesth Analg. 2000 Jan;90(1):168-74. doi: 10.1097/00000539-200001000-00035.
Results Reference
background
PubMed Identifier
21501129
Citation
Royse CF, Andrews DT, Newman SN, Stygall J, Williams Z, Pang J, Royse AG. The influence of propofol or desflurane on postoperative cognitive dysfunction in patients undergoing coronary artery bypass surgery. Anaesthesia. 2011 Jun;66(6):455-64. doi: 10.1111/j.1365-2044.2011.06704.x. Epub 2011 Apr 18.
Results Reference
background
PubMed Identifier
25344591
Citation
Roy S, Smith LP. Surgical fires in laser laryngeal surgery: are we safe enough? Otolaryngol Head Neck Surg. 2015 Jan;152(1):67-72. doi: 10.1177/0194599814555853. Epub 2014 Oct 24.
Results Reference
background
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Early Cognitive Function in Elderly Patients After Laser Laryngeal Surgery: Des vs Prop
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