AzTrials
AzTrials

Spinal DiseaseNCT05148637

General Anesthesia and Regional Cerebral Oxygenation inSpine Surgery Prone Position

A study testing Maintenance of general anesthesia by Sevoflurane, Maintenance of general anesthesia by Desflurane and Anesthesia was maintained by inhalational anesthesia (total intravenous anesthesia by lidocaine, propfol and fentanyl infusions) in people with Spinal Disease, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Spinal Disease
What is being tested?
Maintenance of general anesthesia by Sevoflurane, Maintenance of general anesthesia by Desflurane and Anesthesia was maintained by inhalational anesthesia (total intravenous anesthesia by lidocaine, propfol and fentanyl infusions)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteEgypt
Study dates
1 Nov 2019to 1 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients scheduled for lumbar spinal surgery
  • Procedures performed in the prone position

Who cannot join

  • preexisting neuropsychiatric disorders
  • emergency operation
  • cardiovascular disease
  • respiratory disease
  • central nervous system disease
  • renal dysfunction
  • hepatic dysfunction

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mona Mohamed Mogahed

    Tanta, Elgharbia

Other trials in Egypt

About this study

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

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).

Read the 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.

Conditions
Spinal Disease
Being tested
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)
Medical subject headings
Spinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maintenance of general anesthesia by SevofluraneDrug

    Also called Sevoflurane

    Anesthesia was maintained by inhalational anesthesia (sevoflurane) titrated by monitoring of patient sensitivity index of the Masimo

  • Maintenance of general anesthesia by DesfluraneDrug

    Also called Desflurane

    Anesthesia was maintained by inhalational anesthesia (desflurane) titrated by monitoring of patient sensitivity index of the Masimo

  • Anesthesia was maintained by inhalational anesthesia (total intravenous anesthesia by lidocaine, propfol and fentanyl infusions)Drug

    Also called Total intravenous anesthesia

    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

Study groups in NCT05148637
Study groupRoleWhat they receive
Group IActive comparatoranesthesia maintained by sevoflurane
Receives: Drug: Maintenance of general anesthesia by Sevoflurane
Group IIActive comparatoranesthesia maintained by desflurane
Receives: Drug: Maintenance of general anesthesia by Desflurane
Group IIIActive comparatoranesthesia maintained by TIVA
Receives: Drug: Anesthesia was maintained by inhalational anesthesia (total intravenous anesthesia by lidocaine, propfol and fentanyl infusions)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2021
  2. Study start1 Nov 2019
  3. Primary completion1 Oct 2021
  4. Study completion1 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Montreal Cognitive Assessment (MoCA) were used to assess cognitive function the day before surgery and seventh postoperative day.
Masking
Single blind
Who is masked
Participant
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05148637
Sponsor's protocol ID
34775/7/21
Status last verified
Dec 2021
First submitted
29 Oct 2021
Last updated
3 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Maintenance of general anesthesia by Sevoflurane, Maintenance of general anesthesia by Desflurane and Anesthesia was maintained by inhalational anesthesia (total intravenous anesthesia by lidocaine, propfol and fentanyl infusions) in people with Spinal Disease, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of postoperative cognitive function (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.

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