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

Sponsor

Eye & ENT Hospital of Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03194074

Collaborator

(none)

Enrollment

Location

Arms

27.5

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 15, 2017

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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 Names: 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 Names: Suprane from Baxter

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 Names:

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 Names:

Suprane from Baxter

Outcome Measures

Primary Outcome Measures

Change of Mini-Mental State (MMS) test score [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

Change of Mini-Mental State (MMS) test score [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.