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
  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

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269918

Contacts
Contact: Gretchen Upton 216-444-3289 uptong@ccf.org

Locations
United States, Ohio
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   
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         
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
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:
Neoplasms
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Dexmedetomidine
Remifentanil
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Narcotics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014