Early Cognitive Function in Elderly Patients After Laser Laryngeal Surgery: Des vs Prop (POCDLLS)
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|ClinicalTrials.gov Identifier: NCT03194074|
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : July 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cognition Disorders in Old Age||Drug: Propofol Drug: Desflurane||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|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|
Experimental: propofol group
Propofol/remifentanil-based general anesthesia.
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.
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
- 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
- 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
- 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
- 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 ]
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
|Contact: Xia Shen, M.D.||firstname.lastname@example.org|
|Contact: Hui Qiao, M.D.||email@example.com|
|Principal Investigator:||Xia Shen, M.D.||Eye and ENT Hospital of Fudan University|