A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain
Information source: Outcomes Research Consortium
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adult Intracranial Tumor; Adult Solid Tumor
Intervention: Remifentanil (Drug); Dexmedetomidine (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Outcomes Research Consortium Official(s) and/or principal investigator(s):
Shobana Rajan, MD, Principal Investigator, Affiliation: The Cleveland Clinic
Overall contact:
Gretchen Upton, Phone: 216-444-3289, Email: uptong@ccf.org
Summary
This will be a randomized blinded clinical trial. Patients will be randomized to receive
either a remifentanil or dexmedetomidine infusion for general anesthesia. The anesthesia
team will know the result of randomization at induction. Data will be gathered by research
personnel who will be blinded to the anesthetic method used. Patients will be blinded to
the anesthetic they receive till they are discharged from the PACU when they will have the
option to be unblinded. The Data Safety and - Toxicity Committee will review all serious
adverse events and toxicity reports as well as annual reviews.
Clinical Details
Official title: A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain ReliefPain relief perioperative hemodynamics perioperative hemodynamics perioperative hemodynamics perioperative hemodynamics perioperative hemodynamics
Secondary outcome: Wake Up Time comparisonTime to discharge comparison Side effects evaluation comparison Nursing workload comparison
Detailed description:
Anesthesia for craniotomy presents a unique challenge to the anesthesiologist. Anesthesia
for neurosurgical procedures should provide optimal surgical conditions while maintaining
appropriate cerebral oxygen supply and stable systemic hemodynamics. (1) It is important
to prevent patient response to noxious stimuli during the procedure like pinning, drilling
of the bone, opening and manipulation of the dura etc., avoid coughing and bucking during
surgery and during extubation thus necessitating a deeper level of anesthesia and analgesia.
At the same time it is desirable to have the patient fully awake toward the end of the
surgery in order to facilitate neurologic evaluation. Management of the above presents a
challenge during induction, maintenance and extubation and also during multiple critical
stages of surgery Fear of the side effects of analgesic drugs frequently leads to the
under-treatment of post-craniotomy pain. (2) Nevertheless, this pain continues to be
commonly observed, is frequently severe, and, if unrelieved, may cause distress for the
neurosurgical patient and serious complications for the operative brain. (2) There is a need
for larger trials to delineate safety and efficacy of analgesic therapies with a focus on
short- and long-term outcomes.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Patients who undergo general anesthesia for elective surgical excision of a brain tumor
with following specifications:
- Age: Older than 18
- Primary and redo cases will be included
- Duration of surgery not exceeding 6 hrs.
Exclusion Criteria:
- Patient refusal
- Emergency craniotomy
- Morbid obesity
- Uncontrolled hypertension - DBP more than 110
- Cardiac conduction defects
- Patients with chronic pain.
Locations and Contacts
Gretchen Upton, Phone: 216-444-3289, Email: uptong@ccf.org
Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States; Recruiting
Gretchen Upton, Phone: 216-444-3289, Email: uptong@ccf.org
Andrea Kurz, MD, Phone: 216-445-9924, Email: ak@or.org
The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States; Recruiting
Gretchen Upton, B. Psych, Phone: 216-444-3289, Email: uptong@ccf.org
Shobana Rajan, MD, Principal Investigator
Andrea Kurz, MD, Sub-Investigator
Additional Information
Starting date: February 2011
Last updated: February 8, 2013
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