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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

dina M elgalaly, Bph contact

01154021119 ext. 7209

delgalaly@gmail.com

Egypt1 site, 1 recruiting
  • Children's Cancer Hospital Egypt 57357 Cairo, Egypt

    Cairo

    dina M elgalaly, bph, 01154021119 ext. 7209, delgalaly@gmail.com

    suzan M adlan, MD

    Recruiting

Other trials in Egypt

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.

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 groups in NCT05493228
Study groupRoleWhat they receive
patient is receiving dexmedetomidineExperimentaldexmedetomidine 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 comparatorsaline 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.

  1. Rate of propofol infusion per hour

    measured by infusion pump in ml/hr

    Measured: during surgery

  2. Change in MEP amplitude and latency

    intraoperatively monitoring by neurophysiology in MV

    Measured: at baseline and during surgery

  3. Depth of anesthesia by bispectral index

    intraoperatively by anesthesiologist BIS within normal range 40-60

    Measured: during surgery

  4. change in SSEP amplitude and latency

    intraoperatively monitoring by neurophysiology in MV

    Measured: at baseline and during surgery

Secondary outcomes (3)
  1. to access rapid recovery in both arms

    To access whether using dexmedetomidine infusion will affect time of recovery

    Measured: immediately after surgery

  2. to access the event of hypotension in both arms

    will measured by blood pressure (mmHg)

    Measured: baseline ,during surgery and immediately after surgery

  3. 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.

  1. First posted9 Aug 2022
  2. Study start17 May 2022
  3. Primary completion17 Apr 2023 (estimated)
  4. Study completion30 Oct 2023 (estimated)

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 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)
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

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.

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