Clinical trial NCT03194074: Early Cognitive Function in Elderly Patients After Laser Laryngeal Surgery: Des vs Prop
Official title: Early Cognitive Function and Recovery in Elderly Patients After Laser Laryngeal Surgery: Desflurane-based vs Propofol-based Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cognition Disorders in Old Age
Keywords: Laser Laryngeal Surgery
Desflurane
Propofol
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change of Mini-Mental State (MMS) test score
timeFrame: Change of MMS score between two time points (the day before surgery and 30min postoperatively
Secondary outcomes:
measure: Change of Mini-Mental State (MMS) test score
timeFrame: Change of MMS score between two time points (the day before surgery and 1h postoperatively
measure: Change of Mini-Mental State (MMS) test score
timeFrame: Change of MMS score between two time points (the day before surgery and 3h postoperatively
measure: Change of Mini-Mental State (MMS) test score
timeFrame: Change of MMS score between two time points (the day before surgery and 24h postoperatively
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Xia Shen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.