Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01269918
First received: December 22, 2010
Last updated: October 26, 2016
Last verified: October 2016
  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
Adult Intracranial Tumor
Adult Solid Tumor
Drug: Remifentanil
Drug: Dexmedetomidine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 The Cleveland Clinic:

Primary Outcome Measures:
  • Hemodynamics [ Time Frame: 15, 30, 45, 60, and 90 minutes after extubation. ]
    Hemodynamics were defined as mean arterial pressure (MAP), measured in milimeters of mercury (mmHg). This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation MAP was reported as the aggregate mean across time points.

  • Postoperative Pain [ Time Frame: 15, 30, 45, 60, and 90 minutes after extubation. ]
    Pain was measured using the visual analogue scale (VAS), where 0 is defined as no pain and 10 is defined as worst pain imaginable. This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation pain was reported as the aggregate mean across time points.

  • Total Opioid Consumption [ Time Frame: Initial 90 minutes of recover after surgery ]
    Total opioid consumption was defined as the sum of all opioid doses given within the first 90 minutes after surgery, converted to milligram morphine equivalents.


Secondary Outcome Measures:
  • Heart Rate [ Time Frame: 15, 30, 45, 60, and 90 minutes after extubation. ]
    Heart rate was determined from the arterial catheter and measured as beats per minute. This outcome was analyzed using a repeated measures ANOVA approach.

  • Modified Short Orientation Memory Concentration Test (SOMCT) [ Time Frame: 15, 30, 45, 60, and 90 minutes after extubation. ]
    The Modified Short Orientation Memory Concentration Test (SOMCT) is a validated questionnaire that discriminates among mild, moderate, and severe cognitive deficits. SOMCT is based on 6 questions and produces a total score ranging from 0 (worst possible function) to 28 (best possible function). Scores > 20 are considered normal. This outcome was analyzed using a repeated measures ANOVA approach.

  • Aldrete Score [ Time Frame: 15, 30, 45, 60, and 90 minutes after extubation. ]
    The Aldrete score measured level of sedation and fitness and is used to assess the appropriate departure time from the post anesthesia care unit. The score ranges from 0 to 10, where 0 indicates poor fitness (and such patients are transferred to the ICU), while 10 indicates good fitness. This outcome was analyzed using a repeated measures ANOVA approach.

  • Nursing Workload Comparison [ Time Frame: 90 minutes after extubation ]
    To evaluate the nurses workload when either of the two drugs are given in terms Nursing Research Usage form's therapeutic index scoring system. This score ranges from 0 (minimal interventions and time spent by nurses on study patient) to 22 (maximum interventions and time spent by nurses on the study patient).

  • Drug Stop Time to Open Eyes [ Time Frame: Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes. ]
    time until patient first opened their eyes, squeezed a hand, or wiggled their toes in response to verbal commands after surgery

  • Drug Stop Time to Recall [ Time Frame: Time between extubation until patients could say their names. ]
    Time between extubation until patients could say their names.

  • Drug Stop Time to Fitness to Discharge [ Time Frame: Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes. ]
  • End Case to Post Anesthesia Care Unit (PACU) Discharge [ Time Frame: End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes. ]
    Post Anesthesia Care Unit (PACU) Discharge time is the timing at which patients are discharged from the PACU. This outcome is the amount of time (minutes) from end case to PACU discharge.

  • Postoperative Nausea [ Time Frame: Whether patients had nausea or not, from anesthesia stop time until hospital discharge. ]
    Indicator of whether patients had nausea or not

  • Postoperative Vomitting [ Time Frame: Whether patients had vomiting or not, from anesthesia stop time until hospital discharge. ]
    Indicator of whether patients had postoperative vomiting.

  • Postoperative Shivering [ Time Frame: Whether patients had postoperative or not, from anesthesia stop time until hospital discharge. ]
    Indicator of whether patients had postoperative shivering.


Enrollment: 142
Study Start Date: July 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (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
a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Drug: Dexmedetomidine
a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Shobana Rajan, MD The Cleveland Clinic
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01269918     History of Changes
Other Study ID Numbers: 10-1056
Study First Received: December 22, 2010
Results First Received: June 6, 2016
Last Updated: October 26, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by The Cleveland Clinic:
Craniotomy, pain relief
Adult solid neoplasm

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Dexmedetomidine
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on April 27, 2017