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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cognition Disorders in Old Age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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propofol group

Propofol/remifentanil-based general anesthesia.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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.

desflurane group

Desflurane/remifentanil-based general anesthesia.

Group Type EXPERIMENTAL

Desflurane

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Propofol injection from AstraZeneca Suprane from Baxter

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No