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.
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.
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 group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | anesthesia maintained by sevoflurane Receives: Drug: Maintenance of general anesthesia by Sevoflurane |
| Group II | Active comparator | anesthesia maintained by desflurane Receives: Drug: Maintenance of general anesthesia by Desflurane |
| Group III | Active comparator | anesthesia 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.
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.
- First posted8 Dec 2021
- Study start1 Nov 2019
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Mogahed, Tanta University
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05148637
- Acronym / sponsor ID
- 34775/7/21
- Conditions
- Spinal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Montreal Cognitive Assessment (MoCA) were used to assess cognitive function the day before surgery and seventh postoperative day.
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Maintenance of general anesthesia by Sevofluraneanesthesia maintained by sevoflurane |
| Group II | Active comparator | Drug: Maintenance of general anesthesia by Desfluraneanesthesia maintained by desflurane |
| Group III | Active comparator | Drug: Anesthesia was maintained by inhalational anesthesia (total intravenous anesthesia by lidocaine, propfol and fentanyl infusions)anesthesia maintained by TIVA |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for lumbar spinal surgery
- Procedures performed in the prone position
Key exclusion criteria (7 listed)
- preexisting neuropsychiatric disorders
- emergency operation
- cardiovascular disease
- respiratory disease
- central nervous system disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maintenance of general anesthesia by SevofluraneAlso: SevofluraneAnesthesia was maintained by inhalational anesthesia (sevoflurane) titrated by monitoring of patient sensitivity index of the Masimo | Drug | Group I |
| Maintenance of general anesthesia by DesfluraneAlso: DesfluraneAnesthesia was maintained by inhalational anesthesia (desflurane) titrated by monitoring of patient sensitivity index of the Masimo | Drug | Group II |
| Anesthesia was maintained by inhalational anesthesia (total intravenous anesthesia by lidocaine, propfol and fentanyl infusions)Also: Total intravenous anesthesiaAnesthesia was maintained by inhalational anesthesia (total intravenous anesthesia by lidocaine, propfol and fentanyl infusions) titrated by monitoring of patient sensitivity index of the Masimo | Drug | Group III |
Primary outcome
Assessment of postoperative cognitive function
Time frame: 7 days
Assessment of postoperative cognitive function using mini mental state examination to assess patient's orientation postoperatively by 30-point questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.