Spine CancerPhase 3NCT05493228
Dexmedetomidine Infusion on Intraoperative Propofol,Fentanyl Requirements in Spine Surgery for Pediatric Cancer Patients
A Phase 3 study testing Precedex Injectable Product and Saline in people with Spine Cancer and Anesthesia, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
Trial summary
The purpose of this trial is to investigate whether the effect of a low-dose dexmedetomidine infusion will decrease propofol consumption or not through a double blinded randomized controlled trial done in children cancer hospital 57357. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Spine Cancer, Anesthesia
- What is being tested?
- Precedex Injectable Product and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 17 May 2022to 30 Oct 2023
- Phase
- Phase 3
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- spinal cord tumor resection based on magnetic resonance imaging (MRI) studies.
- age between 5 -18 years old
- American Society of Anesthesiologists (ASA) physical status II or III.
Who cannot join
- Emergency spine surgery
- Cardiac patients
- Any individual with stage 4 or greater chronic kidney disease (eGFR< 30 ml/min) and/or requiring dialysis
- liver failure defined as a history of cirrhosis or fulminant hepatic failure
- Preoperative dexmethatodine use
- Preoperative systolic hypertension defined by a systolic blood pressure greater than 130 mmHg in the surgical admission suite
- Enrolled in another study within 30 days.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Children's Cancer Hospital Egypt 57357 Cairo, Egypt
Cairo
dina M elgalaly, bph, 01154021119 ext. 7209, delgalaly@gmail.com
suzan M adlan, MD
About this study
Official title: the Role of Dexmedetomidine (Precedex) Infusion on Intraoperative Propofol & Fentanyl Requirements in Spine Surgery for Pediatric Cancer Patients
The purpose of this trial is to investigate whether the effect of a low-dose dexmedetomidine infusion will decrease propofol consumption or not through a double blinded randomized controlled trial done in children cancer hospital 57357.
Read the detailed description
Spinal surgery with instrumentation is associated with the risk of iatrogenic injuries to the spinal cord. The combination of somatosensory evoked potential (SSEP) and transcranial electric motor evoked potential (tcemep) monitoring has resulted in a high degree of sensitivity in predicting postoperative neurologic outcomes. Anesthetic agents have a dose-dependent adverse effect on the ability to record evoked potential responses. Many commonly used anesthetic agents produce a dose-dependent amplitude reduction and latency prolongation of evoked responses, which may impair diagnosis of intraoperative spinal cord injury. Neuroprotection is the cornerstone of anesthetic management in neurosurgery. Preserving the quality of SSEP and motor evoked potential (MEP) and minimizing the effects of anesthetic agents on neurologic monitoring are thus investigators' priorities.
Motor-evoked potential (MEP) and somatosensory-evoked potential (SSEP) monitoring are universally used during spine surgeries, which poses risks to the functional integrity of descending motor and ascending sensory pathways.
MEP baseline recording is obtained at the start of surgery determining the amplitude. The alarming criteria for MEP are attenuation of more than 50 % in motor response amplitude for segmental tcMEP, more than 80 % for long tract tcMEP and/or abolishment of tcMEP data. Any significant change is immediately reported to the surgeons.
Prior to skin incision, SSEP baseline amplitude and latency of cortical potential peaks were recorded (N20 for upper SSEP and P37 for lower SSEP). The alarming criteria of SSEP are 50% decreased amplitude and/or more than 10% increased latency compared to baseline.
The anesthetic agents have effects on the latency and amplitude of MEP and SSEP monitoring which is dose-dependent. Total intravenous anesthesia (TIVA) with propofol and opioid is commonly recommended for surgeries that require MEP and SSEP monitoring. However, propofol administered with a large dose affects MEP monitoring.
Using dexmedetomidine has the ability of sparing hypnotics usage, especially propofol, thus facilitating MEP and SSEP monitoring with providing its beneficial effects.
The addition of dexmedetomidine (0.5 μg/kg loading dose infused over 10 min followed by a constant infusion rate of 0.5 μg/kg/h) to propofol-remifentanil regimen does not exert an adverse effect on MEP and SSEP monitoring in adult patients undergoing thoracic spinal cord tumor resection and the addition of dexmedetomidine reduces the propofol requirements for a comparable BIS measurement. Another study that supports this regimen concluded that SEPs and MEPs were maintained in the patients who are administered with the dexmedetomidine etomidate fentanyl combined anesthesia during spinal surgery. Also, it was find that dexmedetomidine changes SSEP amplitude at clinically nonsignificant levels and may be safely used in intraoperative nerve monitoring at up to 1.2mg/ kg/h .
The most attractive form of display for the calculated power spectrum during anaesthesia is the compressed spectral array (CSA), where the component power is plotted as a function of frequency for each analysed epoch. Power spectrum analysis and subsequent display of data in the CSA format provide a simplified identification of small changes in a complex EEG.
Total intravenous anesthesia (TIVA) with propofol and opioid is commonly recommended for surgeries that require MEP and SSEP monitoring. However, even propofol used with a large dose can also affect MEP monitoring. Despite its efficacy, dose-related adverse effects may occur with propofol including prolonged awakening times, lipemia, and alteration of platelet function. Additionally, although more of a concern with its prolonged use in the ICU setting, recent attention has focused on the potential development of the 'propofol infusion syndrome' during intraoperative care.
Dexmedetomidine, an alpha 2-receptor agonist, is routinely used to provide analgesia and sedation without respiratory depression in critically ill patients. Its hemodynamic stability, negligible respiratory depression, and reduction of other anesthetic and analgesic requirements make it an interesting option for intraoperative use as an adjunctive agent for general anesthesia .When dexmedetomidine is added to a propofol infusion, it decreases the dose of propofol required,provides moderate hypotension, decreases blood loss, and allows monitoring of MEPs and SSEPs. The dose of dexmedetomidine often quoted in the literature is a bolus of 1 μg kg-1 hr-1 over 10 min followed by infusion of 0.2-0.7 μg kg-1 hr-1, but this dose frequently results in bradycardia and hypotension. Recently,this study is planned to evaluate the effects of intraoperative IV infusion of a low-dose (0.5 μg kg-1 hr-1) dexmedetomidine in patients undergoing spine surgery.
Researchers have administered an intraoperative continuous infusion of lower doses of dexmedetomidine without a prior bolus.
- Conditions
- Spine Cancer, Anesthesia
- Being tested
- Precedex Injectable Product, Saline
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precedex Injectable ProductDrug
Also called dexmedetomidine
Precedex activates 2-adrenoceptors, and causes the decrease of sympathetic tone, with attenuation of the neuroendocrine and hemodynamic responses to anesthesia and surgery; it reduces anesthetic and opioid requirements; and causes sedation and analgesia. it is used before and/or during surgical
SalineDrug
Also called Salt water
mixture of sodium chloride (salt) and water in solution with 0.90% w/v of NaCl
| Study group | Role | What they receive |
|---|---|---|
| patient is receiving dexmedetomidine | Experimental | dexmedetomidine infusion at the rate of 0.5 μg kg-1 hr-1, started after the induction of general anesthesia without a loading dose Receives: Drug: Precedex Injectable Product |
| standard treatment (saline) | Placebo comparator | saline injection only after the induction of general anesthesia Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of propofol infusion per hour
measured by infusion pump in ml/hr
Measured: during surgery
Change in MEP amplitude and latency
intraoperatively monitoring by neurophysiology in MV
Measured: at baseline and during surgery
Depth of anesthesia by bispectral index
intraoperatively by anesthesiologist BIS within normal range 40-60
Measured: during surgery
change in SSEP amplitude and latency
intraoperatively monitoring by neurophysiology in MV
Measured: at baseline and during surgery
Secondary outcomes (3)
to access rapid recovery in both arms
To access whether using dexmedetomidine infusion will affect time of recovery
Measured: immediately after surgery
to access the event of hypotension in both arms
will measured by blood pressure (mmHg)
Measured: baseline ,during surgery and immediately after surgery
to access the event of bradycardia in both arms
will measured by Heart rate (beat/min)
Measured: baseline, during surgery and immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start17 May 2022
- Primary completion17 Apr 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, double-blinded clinical trial will be done on all included cases. They will be divided into two groups after induction of general anathesia using propofolwhich will be started at 100 ug/kg/min) and titrated to maintain the bispectral index at 40-60 and fentanyl will be started at 0.5ug/kg/min) and to be adjusted as needed to control the hemodynamic response to the surgical procedure and maintain the mean arterial pressure (MAP) at 55-65 mmHg. Then will randomly divided using Block Stratified Randomized Software program, after obtaining informed consent from eligible patient or his caregiver into two Arms: Arm A: will receive dexmedetomidine infusion at the rate of 0.5 μg kg-1 hr-1, started after the induction of general anesthesia without a loading dose which is colorless solution. Arm B :will receive placebo (saline injection) only after the induction of general anesthesia
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- suzan m Adlan, MD, Principal investigator, 57357 children cancer hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493228
- Sponsor's protocol ID
- CCHE-BT005
- Status last verified
- Jun 2022
- First submitted
- 1 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Role of Dexmedetomidine (Precedex) Infusion on Intraoperative Propofol & Fentanyl Requirements in Spine Surgery for Pediatric Cancer Patients
- ClinicalTrials.gov ID
- NCT05493228
- Acronym / sponsor ID
- CCHE-BT005
- Conditions
- Spine Cancer, Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Children's Cancer Hospital Egypt 57357University, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 17 Apr 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 9 Aug 2022 (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.
The purpose of this trial is to investigate whether the effect of a low-dose dexmedetomidine infusion will decrease propofol consumption or not through a double blinded randomized controlled trial done in children cancer hospital 57357.
Detailed description
Spinal surgery with instrumentation is associated with the risk of iatrogenic injuries to the spinal cord. The combination of somatosensory evoked potential (SSEP) and transcranial electric motor evoked potential (tcemep) monitoring has resulted in a high degree of sensitivity in predicting postoperative neurologic outcomes. Anesthetic agents have a dose-dependent adverse effect on the ability to record evoked potential responses. Many commonly used anesthetic agents produce a dose-dependent amplitude reduction and latency prolongation of evoked responses, which may impair diagnosis of intraoperative spinal cord injury. Neuroprotection is the cornerstone of anesthetic management in neurosurgery. Preserving the quality of SSEP and motor evoked potential (MEP) and minimizing the effects of anesthetic agents on neurologic monitoring are thus investigators' priorities.
Motor-evoked potential (MEP) and somatosensory-evoked potential (SSEP) monitoring are universally used during spine surgeries, which poses risks to the functional integrity of descending motor and ascending sensory pathways.
MEP baseline recording is obtained at the start of surgery determining the amplitude. The alarming criteria for MEP are attenuation of more than 50 % in motor response amplitude for segmental tcMEP, more than 80 % for long tract tcMEP and/or abolishment of tcMEP data. Any significant change is immediately reported to the surgeons.
Prior to skin incision, SSEP baseline amplitude and latency of cortical potential peaks were recorded (N20 for upper SSEP and P37 for lower SSEP). The alarming criteria of SSEP are 50% decreased amplitude and/or more than 10% increased latency compared to baseline.
The anesthetic agents have effects on the latency and amplitude of MEP and SSEP monitoring which is dose-dependent. Total intravenous anesthesia (TIVA) with propofol and opioid is commonly recommended for surgeries that require MEP and SSEP monitoring. However, propofol administered with a large dose affects MEP monitoring.
Using dexmedetomidine has the ability of sparing hypnotics usage, especially propofol, thus facilitating MEP and SSEP monitoring with providing its beneficial effects.
The addition of dexmedetomidine (0.5 μg/kg loading dose infused over 10 min followed by a constant infusion rate of 0.5 μg/kg/h) to propofol-remifentanil regimen does not exert an adverse effect on MEP and SSEP monitoring in adult patients undergoing thoracic spinal cord tumor resection and the addition of dexmedetomidine reduces the propofol requirements for a comparable BIS measurement. Another study that supports this regimen concluded that SEPs and MEPs were maintained in the patients who are administered with the dexmedetomidine etomidate fentanyl combined anesthesia during spinal surgery. Also, it was find that dexmedetomidine changes SSEP amplitude at clinically nonsignificant levels and may be safely used in intraoperative nerve monitoring at up to 1.2mg/ kg/h .
The most attractive form of display for the calculated power spectrum during anaesthesia is the compressed spectral array (CSA), where the component power is plotted as a function of frequency for each analysed epoch. Power spectrum analysis and subsequent display of data in the CSA format provide a simplified identification of small changes in a complex EEG.
Total intravenous anesthesia (TIVA) with propofol and opioid is commonly recommended for surgeries that require MEP and SSEP monitoring. However, even propofol used with a large dose can also affect MEP monitoring. Despite its efficacy, dose-related adverse effects may occur with propofol including prolonged awakening times, lipemia, and alteration of platelet function. Additionally, although more of a concern with its prolonged use in the ICU setting, recent attention has focused on the potential development of the 'propofol infusion syndrome' during intraoperative care.
Dexmedetomidine, an alpha 2-receptor agonist, is routinely used to provide analgesia and sedation without respiratory depression in critically ill patients. Its hemodynamic stability, negligible respiratory depression, and reduction of other anesthetic and analgesic requirements make it an interesting option for intraoperative use as an adjunctive agent for general anesthesia .When dexmedetomidine is added to a propofol infusion, it decreases the dose of propofol required,provides moderate hypotension, decreases blood loss, and allows monitoring of MEPs and SSEPs. The dose of dexmedetomidine often quoted in the literature is a bolus of 1 μg kg-1 hr-1 over 10 min followed by infusion of 0.2-0.7 μg kg-1 hr-1, but this dose frequently results in bradycardia and hypotension. Recently,this study is planned to evaluate the effects of intraoperative IV infusion of a low-dose (0.5 μg kg-1 hr-1) dexmedetomidine in patients undergoing spine surgery.
Researchers have administered an intraoperative continuous infusion of lower doses of dexmedetomidine without a prior bolus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A prospective, randomized, double-blinded clinical trial will be done on all included cases. They will be divided into two groups after induction of general anathesia using propofolwhich will be started at 100 ug/kg/min) and titrated to maintain the bispectral index at 40-60 and fentanyl will be started at 0.5ug/kg/min) and to be adjusted as needed to control the hemodynamic response to the surgical procedure and maintain the mean arterial pressure (MAP) at 55-65 mmHg. Then will randomly divided using Block Stratified Randomized Software program, after obtaining informed consent from eligible patient or his caregiver into two Arms: Arm A: will receive dexmedetomidine infusion at the rate of 0.5 μg kg-1 hr-1, started after the induction of general anesthesia without a loading dose which is colorless solution. Arm B :will receive placebo (saline injection) only after the induction of general anesthesia
| Arm | Type | Receives |
|---|---|---|
| patient is receiving dexmedetomidine | Experimental | Drug: Precedex Injectable Productdexmedetomidine infusion at the rate of 0.5 μg kg-1 hr-1, started after the induction of general anesthesia without a loading dose |
| standard treatment (saline) | Placebo comparator | Drug: Salinesaline injection only after the induction of general anesthesia |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- spinal cord tumor resection based on magnetic resonance imaging (MRI) studies.
- age between 5 -18 years old
- American Society of Anesthesiologists (ASA) physical status II or III.
Key exclusion criteria (7 listed)
- Emergency spine surgery
- Cardiac patients
- Any individual with stage 4 or greater chronic kidney disease (eGFR< 30 ml/min) and/or requiring dialysis
- liver failure defined as a history of cirrhosis or fulminant hepatic failure
- Preoperative dexmethatodine use
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 |
|---|---|---|
| Precedex Injectable ProductAlso: dexmedetomidinePrecedex activates 2-adrenoceptors, and causes the decrease of sympathetic tone, with attenuation of the neuroendocrine and hemodynamic responses to anesthesia and surgery; it reduces anesthetic and opioid requirements; and causes sedation and analgesia. it is used before and/or during surgical | Drug | patient is receiving dexmedetomidine |
| SalineAlso: Salt watermixture of sodium chloride (salt) and water in solution with 0.90% w/v of NaCl | Drug | standard treatment (saline) |
Primary outcome
Rate of propofol infusion per hour
Time frame: during surgery
measured by infusion pump in ml/hr
Change in MEP amplitude and latency
Time frame: at baseline and during surgery
intraoperatively monitoring by neurophysiology in MV
Depth of anesthesia by bispectral index
Time frame: during surgery
intraoperatively by anesthesiologist BIS within normal range 40-60
change in SSEP amplitude and latency
Time frame: at baseline and during surgery
intraoperatively monitoring by neurophysiology in MV
3 secondary outcomes
to access rapid recovery in both arms
Time frame: immediately after surgery
to access the event of hypotension in both arms
Time frame: baseline ,during surgery and immediately after surgery
to access the event of bradycardia in both arms
Time frame: baseline, during surgery and immediately after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
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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.
suzan m Adlan, MD principal investigator
57357 children cancer hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Precedex Injectable Product and Saline in people with Spine Cancer and Anesthesia, run by Children's Cancer Hospital Egypt 57357 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 3 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: status not confirmed, as of the sponsor's last update on 9 Aug 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact dina M elgalaly, Bph (01154021119 ext. 7209, delgalaly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of propofol infusion per hour (time frame: during surgery). The study lists 4 primary outcomes in all. 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 9 Aug 2022.