A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain (RemivsDex)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Outcomes Research Consortium
Sponsor:
Information provided by (Responsible Party):
Shobana Rajan, Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT01269918
First received: December 22, 2010
Last updated: February 8, 2013
Last verified: February 2013

December 22, 2010
February 8, 2013
February 2011
February 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01269918 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain
A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Adult Intracranial Tumor
  • Adult Solid Tumor
  • Drug: Remifentanil
    Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
    Other Name: Ultiva, G187084B
  • 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
  • Active Comparator: Remifentanil
    Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
    Intervention: Drug: Remifentanil
  • Active Comparator: Dexmedetomidine
    DEXMEDETOMIDINE 0.4-0.7MCG/KG/HR (0.006-0.012mcg/kg/min) THROUGHOUT THE PROCEDURE BASED ON HEMODYNAMICS
    Intervention: Drug: Dexmedetomidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
142
March 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Gretchen Upton 216-444-3289 uptong@ccf.org
United States
 
NCT01269918
10-1056
Yes
Shobana Rajan, Outcomes Research Consortium
Outcomes Research Consortium
Not Provided
Principal Investigator: Shobana Rajan, MD The Cleveland Clinic
Outcomes Research Consortium
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP