A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Post-Surgical Pain, Brain Cancer |
| Therapuetic Areas: | Musculoskeletal, Oncology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | February 2011 |
| End Date: | March 2013 |
| Contact: | Gretchen Upton |
| Email: | uptong@ccf.org |
| Phone: | 216-444-3289 |
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.
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.
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.
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.
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.
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