Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05148637 |
| Other study ID # |
34775/7/21 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2019 |
| Est. completion date |
October 1, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
Tanta University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Elderly patients are reportedly at higher risk of postoperative cognitive dysfunction
(POCD).The authors hypothesized that the incidence of POCD would be affected by several
factors including, the age of the patient, the degree of cerebral oxygenation, type of
anesthesia administered, majority of surgery and the patient position during surgery.The
investigators examined the relationship between all the previous parameters and (POCD).
Description:
105 patients 65 years or older and scheduled for lumbar spinal surgery will be enrolled.
Enrolled patients have either degenerative lumbar spinal stenosis or spinal cord tumor. The
planned surgical procedures will be all performed in the prone position using the Wilson
frame with the head and neck in the neutral position and included laminectomy and discectomy,
spinal fusion, and (when present) removal of the spinal cord tumor. Written informed consent
for participation in this study will be obtained from all patients.
Patients will be screened within 1 week before the scheduled surgery. Details and medical
comorbidities, Inclusion criteria were as follows: elective spine surgery in prone position,
60-75 years old, American Society of Anesthesiologists (ASA) physical status score of I,II or
III, and body mass index (BMI) ranging from 22 to 45 kg/m2 , patients should have a
sufficient level of education to be capable of completing neuropsychological tests; a
pre-operative mini mental state examination (MMSE) score ≥23. Exclusion criteria were as
follows: preexisting neuropsychiatric disorders or inability to correctly perform
neurocognitive tests on the patient, emergency operation, diagnosis of coma, depression,
cognitive impairment, cardiovascular, respiratory or central nervous system disease, renal or
hepatic dysfunction or serious hearing or visual impairment;
In the operating room, Patients were monitored by 5 lead electrocardiogram, invasive arterial
blood pressure (IABP) through the arterial catheter and (Masimo®, Irvine, CA) which provides
non-invasive continuous technologies for monitoring and measuring many physiological
variables such as arterial oxygen saturation (SpO2), heart rate (HR) and hemoglobin
concentration (Hb%), end tidal CO2, noninvasive blood pressure, body temperature, (O3 ®,
Masimo, Irvine, CA) attached to the patient to provide continuous monitoring of regional
cerebral oxygen saturation (rSO2) of the two sides by a near-infrared spectroscopy sensors.
(SedLine ®, Masimo, CA) brain function monitoring by Patient State Index (PSI) which is a
processed EEG parameter affected by the anesthetic agents.
Patients were randomly divided into three groups 35 each; group I: anesthesia maintained by
sevoflurane, group II: anesthesia maintained by desflurane, and group III: anesthesia
maintained by TIVA. In all groups the doses of anesthetics were adjusted to maintain (Psi)
(patient sensitivity index) between 25-50% measured by (SedLine, Masimo®, CA) rocuronium
boluses were given to maintain stable neuromuscular block.
Anesthesia was managed according to a standardized protocol that was identical for each
group. Following 3 min of pre-oxygenation (with 100 % O2), anesthesia was induced by slow
intravenous injection of propofol (1-2 mg/kg), fentanil (1-μg /kg). Tracheal intubation was
facilitated with Rocrunium (0.4-0.6mg/kg) Mechanical ventilation was initiated with a tidal
volume of 7 ml/kg, a respiratory rate of 12 /min, a positive end expiratory pressure of 5
cmH2O and inspiratory-expiratory ratio of 1:2 to maintain PETCO2 in the range 35-40 mmHg.
Oxygen flow rate was set at 2 l/min.
Anesthesia was maintained in the three Groups by sevoflurane , desflurane, and propofol to
target PSI to 25-50 fentanyl 100μg/h and boluses of rocrunium were used to supplement
maintenance of anesthesia.
Patients' demographic and basic clinical characteristics, fluid balance, blood loss, duration
of surgery, temperature, time taken for recovery of spontaneous breathing, eye opening on
command and time taken for extubation were also recorded. HR, mean arterial pressure (MAP)
and central venous pressure were recorded at five perioperative time points: on entering the
operating room (T0); before tracheal intubation (T1); before surgery (T2); immediately after
surgery (T3) and immediately after tracheal extubation (T4). . In the operating room,
patients were laid in the supine position, and a The patient's baseline rSO2 data were
acquired before anesthetic induction while the patient breathed room air. The
anesthesiologists and surgeons were blinded to the rSO2 data, which wererecorded at 30-second
intervals on the device's accessory disk drive for later analysis. No interventions were
attempted based on the device. Both the right and the left frontal rSO2 values wererecorded
simultaneously, and the lower value of either side werecollected for analysis.
Assessment of perioperative cognitive function The MMSE and Montreal Cognitive Assessment
(MoCA) were used to assess cognitive function the day before surgery and seventh
postoperative day. All data collectors had undergone standard training, and were blinded to
the randomization status of the participants. The MMSE consists of tests of orientation (in
time and place), memory (immediate and short-term), calculation, language (naming,
repetition, listening and reading comprehension, writing), visual spatial awareness,
concentration and attention, and is suitable for detecting more severe cognitive dysfunction.
The MoCA tests visuospatial and executive function (alternate trail making test, copy the
cube, clock drawing), language ability, attention and calculation, delayed recall and
abstract thinking, and can detect milder cognitive dysfunction. Patients' cognitive function
was evaluated by MoCA if the MMSE score equaled or exceeded 23.
