the Role of Dexmedetomidine (Precedex) Infusion on Intraoperative Propofol & Fentanyl Requirements in Spine Surgery for Pediatric Cancer Patients
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Change in MEP amplitude and latency
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
The PI (anesthesiologist), neurosurgeon ,patient, all assisting surgeons and anesthesiologist as well operating and circulating nurse will be blinded to the study arm to which patient belongs to. Only clinical trial unit and pharmacist will be unblinded.
Eligibility Criteria
- Ages
- 5 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
patient is receiving dexmedetomidine
dexmedetomidine infusion at the rate of 0.5 μg kg-1 hr-1, started after the induction of general anesthesia without a loading dose
Intervention: Precedex Injectable Product (Drug)
standard treatment (saline)
saline injection only after the induction of general anesthesia
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
Change in MEP amplitude and latency
Time Frame: at baseline and during surgery
intraoperatively monitoring by neurophysiology in MV
Rate of propofol infusion per hour
Time Frame: during surgery
measured by infusion pump in ml/hr
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
Secondary Outcomes
- to access rapid recovery in both arms(immediately after surgery)
- to access the event of hypotension in both arms(baseline ,during surgery and immediately after surgery)
- to access the event of bradycardia in both arms(baseline, during surgery and immediately after surgery)