A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain (RemivsDex)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adult Intracranial Tumor Adult Solid Tumor |
Drug: Remifentanil Drug: Dexmedetomidine |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain |
- Pain Relief [ Time Frame: every 15 minutes, during the first hour ] [ Designated as safety issue: No ]The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) pain relief.
- Pain relief [ Time Frame: every hour ] [ Designated as safety issue: No ]The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) pain relief
- perioperative hemodynamics [ Time Frame: 15 minutes after arrival in PACU ] [ Designated as safety issue: No ]The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) perioperative hemodynamics.
- perioperative hemodynamics [ Time Frame: 30 minutes after arrival in PACU ] [ Designated as safety issue: No ]The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) perioperative hemodynamics.
- perioperative hemodynamics [ Time Frame: 45 minutes after arrival in PACU ] [ Designated as safety issue: No ]The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) perioperative hemodynamics.
- perioperative hemodynamics [ Time Frame: one hour after arrival in PACU ] [ Designated as safety issue: No ]The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) perioperative hemodynamics.
- perioperative hemodynamics [ Time Frame: 90 minutes after arrival in PACU ] [ Designated as safety issue: No ]The primary aims of our study is to compare the two agents in terms of PACU (post anesthesia Care unit) perioperative hemodynamics.
- Wake Up Time comparison [ Time Frame: from study drug stop until subject is alert ] [ Designated as safety issue: No ]To compare the wake up time between Dexmedetomidine and Remifentanil. To compare the time to neurological evaluation (orientation to person/time and place) between the two drugs
- Time to discharge comparison [ Time Frame: discharge from PACU comparison ] [ Designated as safety issue: No ]To Compare the time to fitness to discharge from PACU based on Aldrete's score.
- Side effects evaluation comparison [ Time Frame: during time in PACU ] [ Designated as safety issue: No ]To evaluate side effects like nausea, emesis and shivering
- Nursing workload comparison [ Time Frame: during PACU stay ] [ Designated as safety issue: No ]To evaluate the nurses workload when either of the two drugs are given in terms of a scoring sheet given to the nurses.
| Estimated Enrollment: | 142 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Remifentanil
Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
|
Drug: Remifentanil
Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
Other Name: Ultiva, G187084B
|
|
Active Comparator: Dexmedetomidine
DEXMEDETOMIDINE 0.4-0.7MCG/KG/HR (0.006-0.012mcg/kg/min) THROUGHOUT THE PROCEDURE BASED ON HEMODYNAMICS
|
Drug: Dexmedetomidine
DEXMEDETOMIDINE 0.4-0.7MCG/KG/HR (0.006-0.012mcg/kg/min) THROUGHOUT THE PROCEDURE BASED ON HEMODYNAMICS
Other Name: Precedex, Dexmedetomidine Hydrochloride
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Gretchen Upton | 216-444-3289 | uptong@ccf.org |
| United States, Ohio | |
| The Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Gretchen Upton, B. Psych 216-444-3289 uptong@ccf.org | |
| Principal Investigator: Shobana Rajan, MD | |
| Sub-Investigator: Andrea Kurz, MD | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Gretchen Upton 216-444-3289 uptong@ccf.org | |
| Contact: Andrea Kurz, MD 216-445-9924 ak@or.org | |
| Principal Investigator: | Shobana Rajan, MD | The Cleveland Clinic |
More Information
No publications provided
| Responsible Party: | Shobana Rajan, Principal Investigator, Outcomes Research Consortium |
| ClinicalTrials.gov Identifier: | NCT01269918 History of Changes |
| Other Study ID Numbers: | 10-1056 |
| Study First Received: | December 22, 2010 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Outcomes Research Consortium:
|
Craniotomy, pain relief Adult solid neoplasm |
Additional relevant MeSH terms:
|
Pain, Postoperative Brain Neoplasms Postoperative Complications Pathologic Processes Pain Signs and Symptoms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Dexmedetomidine Remifentanil |
Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 16, 2013