General Anesthesia and Regional Cerebral Oxygenation inSpine Surgery Prone Position
Primary Purpose
Spinal Disease
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Maintenance of general anesthesia by Sevoflurane
Maintenance of general anesthesia by Desflurane
Anesthesia was maintained by inhalational anesthesia (total intravenous anesthesia by lidocaine, propfol and fentanyl infusions)
Sponsored by
About this trial
This is an interventional other trial for Spinal Disease
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for lumbar spinal surgery
- Procedures performed in the prone position
Exclusion Criteria:
- preexisting neuropsychiatric disorders
- emergency operation
- cardiovascular disease
- respiratory disease
- central nervous system disease
- renal dysfunction
- hepatic dysfunction
Sites / Locations
- Mona Mohamed Mogahed
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group I
Group II
Group III
Arm Description
anesthesia maintained by sevoflurane
anesthesia maintained by desflurane
anesthesia maintained by TIVA
Outcomes
Primary Outcome Measures
Assessment of postoperative cognitive function
Assessment of postoperative cognitive function using mini mental state examination to assess patient's orientation postoperatively by 30-point questionnaire
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05148637
Brief Title
General Anesthesia and Regional Cerebral Oxygenation inSpine Surgery Prone Position
Official Title
The Effect of Different Modalities of General Anesthesia and Regional Cerebral Oxygenation on Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Spine Surgery in Prone Position
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Montreal Cognitive Assessment (MoCA) were used to assess cognitive function the day before surgery and seventh postoperative day.
Masking
Participant
Masking Description
The methods of anesthesia were described to the enrolled patients preoperatively, but the patients were unaware about their group.
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Active Comparator
Arm Description
anesthesia maintained by sevoflurane
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
anesthesia maintained by desflurane
Arm Title
Group III
Arm Type
Active Comparator
Arm Description
anesthesia maintained by TIVA
Intervention Type
Drug
Intervention Name(s)
Maintenance of general anesthesia by Sevoflurane
Other Intervention Name(s)
Sevoflurane
Intervention Description
Anesthesia was maintained by inhalational anesthesia (sevoflurane) titrated by monitoring of patient sensitivity index of the Masimo
Intervention Type
Drug
Intervention Name(s)
Maintenance of general anesthesia by Desflurane
Other Intervention Name(s)
Desflurane
Intervention Description
Anesthesia was maintained by inhalational anesthesia (desflurane) titrated by monitoring of patient sensitivity index of the Masimo
Intervention Type
Drug
Intervention Name(s)
Anesthesia was maintained by inhalational anesthesia (total intravenous anesthesia by lidocaine, propfol and fentanyl infusions)
Other Intervention Name(s)
Total intravenous anesthesia
Intervention Description
Anesthesia was maintained by inhalational anesthesia (total intravenous anesthesia by lidocaine, propfol and fentanyl infusions) titrated by monitoring of patient sensitivity index of the Masimo
Primary Outcome Measure Information:
Title
Assessment of postoperative cognitive function
Description
Assessment of postoperative cognitive function using mini mental state examination to assess patient's orientation postoperatively by 30-point questionnaire
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for lumbar spinal surgery
Procedures performed in the prone position
Exclusion Criteria:
preexisting neuropsychiatric disorders
emergency operation
cardiovascular disease
respiratory disease
central nervous system disease
renal dysfunction
hepatic dysfunction
Facility Information:
Facility Name
Mona Mohamed Mogahed
City
Tanta
State/Province
Elgharbia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
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General Anesthesia and Regional Cerebral Oxygenation inSpine Surgery Prone Position
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