Study of Dexmedetomidine in Spine Surgery
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 5/6/2017 |
| Start Date: | August 2012 |
| End Date: | May 2015 |
Prospective Randomized Double Blind Study of Intraoperative Dexmedetomidine and Postoperative Pain Control in Patients Undergoing Multi-level Thoraco-lumbar Spine Surgery
The investigators will conduct a prospective randomized double blind study comparing
methadone plus methadone and intraoperative dexmedetomidine in multi-level spine surgery in
two randomized groups. The investigators plan to document the intraoperative opioid
requirements, time to first dose of opioids postoperatively and total opioid consumption in
the first 24, 48 and 72 hours. The incidence of intra and postoperative complications will
be assessed.
methadone plus methadone and intraoperative dexmedetomidine in multi-level spine surgery in
two randomized groups. The investigators plan to document the intraoperative opioid
requirements, time to first dose of opioids postoperatively and total opioid consumption in
the first 24, 48 and 72 hours. The incidence of intra and postoperative complications will
be assessed.
Patients presenting for thoracic and/or lumbar spine surgery with neuromonitoring
(MEP/SSEP/EMG)will be recruited. Standard anesthesia monitoring will be performed.
Randomized to a placebo or dexmedetomidine arm. Both groups will receive methadone 0.2 mg/kg
ideal weight after induction of anesthesia.
The placebo/dexmedetomidine will be loaded at 1 mcg/kg over 20 minutes and then a continuous
infusion of 0.5 mcg/kg/h for the duration of the procedure.
Intraoperative analgesia will be provided with fentanyl and dilaudid per the anesthesia
team.
Upon closure the study drug will be terminated. Patients will be followed up for 72 hours
after surgery. Total opiate consumption and visual analogue scale ratings will be
documented.
Intra and postoperative inotrope/pressor requirements will be recorded.
(MEP/SSEP/EMG)will be recruited. Standard anesthesia monitoring will be performed.
Randomized to a placebo or dexmedetomidine arm. Both groups will receive methadone 0.2 mg/kg
ideal weight after induction of anesthesia.
The placebo/dexmedetomidine will be loaded at 1 mcg/kg over 20 minutes and then a continuous
infusion of 0.5 mcg/kg/h for the duration of the procedure.
Intraoperative analgesia will be provided with fentanyl and dilaudid per the anesthesia
team.
Upon closure the study drug will be terminated. Patients will be followed up for 72 hours
after surgery. Total opiate consumption and visual analogue scale ratings will be
documented.
Intra and postoperative inotrope/pressor requirements will be recorded.
Inclusion Criteria:
- Age 18-80 years of age
- Elective multi-level thoracic and/or lumbar spine surgery requiring SSEP, EMG or MEP
monitoring
Exclusion Criteria:
- Emergency spine surgery
- Age < 18 years
- Pregnant patients
- Advanced heart block: Mobitz type II block or atrio-ventricular dissociation in a
previous EKG.
- Any individual with stage 4 or greater chronic kidney disease (eGFR< 30 ml/min)
and/or requiring dialysis or liver failure defined as a history of cirrhosis or
fulminant hepatic failure
- Any individuals on preoperative methadone therapy
- Preoperative dexmedetomidine use
- Preoperative systolic hypertension defined by a systolic blood pressure greater than
150 mmHg in the surgical admission suite
- Enrolled in another study within 30 days
We found this trial at
1
site
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
Click here to add this to my saved trials
