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Comparison of Dexmedetomidine and Propofol-Remifentanil Conscious Sedation for Awake Craniotomy for Tumor Surgery: a Randomized Controlled Trial

18 Years
Open (Enrolling)
Brain Tumor

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Trial Information

Comparison of Dexmedetomidine and Propofol-Remifentanil Conscious Sedation for Awake Craniotomy for Tumor Surgery: a Randomized Controlled Trial

Awake craniotomy for resection of brain tumor located in close proximity to areas of
eloquent brain function, such as speech, motor and sensory, is an accepted procedure used to
minimize neurological injury during resection. The level of sedation and analgesia during
the different stages of surgery varies, but importantly, the patient needs to be awake and
alert during brain mapping. During awake craniotomy, anesthesia is usually provided using a
combination of local anesthesia (regional scalp block and/or local infiltration) and
intravenous (IV) agents to provide sedation, anxiolysis and analgesia. There is considerable
variation in the anesthetic management of the awake craniotomy in different institutions.
Propofol sedation, commonly in combination with a shorter acting opioid such as fentanyl, or
remifentanil, is an effective and popular technique during awake craniotomy, achieving a
high degree of patient satisfaction and acceptance. However, the awake craniotomy remains
one of the most challenging techniques of anesthesia care in terms of balancing an adequate
depth of sedation and analgesia to combat the rapid changes of surgical stimulation yet
having an alert patient for brain mapping. Furthermore, most of the anesthetic agents are
associated with some respiratory depression.

A newer anesthetic agent called dexmedetomidine (Precedex (TM), Hospira Healthcare
Corporation, Saint Laurent, Québec, Canada) is a potent, highly selective α2-adrenoceptor
agonist with an α2:α1 selectivity ratio of 1600:1. It has been available in the Canada since
2009 as a short-term sedative agent, and is available in the UHN. The use of dexmedetomidine
has been in mechanically ventilated patients in ICU and for intra-operative sedation. The
well-documented beneficial effects of dexmedetomidine are anxiolysis, analgesia, sedation
and sympatholysis, and it is not associated with respiratory depressive effect.

Dexmedetomidine has been successfully used to provide sedation in dental procedures, awake
fibreoptic intubation, bariatric surgery and morbidly obese patients, as well as obstructive
sleep apnea patients. The pharmacokinetic properties of dexmedetomidine is very predictable
and titratable, with a rapid distribution half-life (t1/2α) being approximately 5-6min and
an elimination half-life (t1/2β) of approximately 2h. Bekker et al. first reported the
successful use of dexmedetomidine in awake craniotomy in 2001. Subsequent case series
published by Souter et al. demonstrated that dexmedetomidine can be used either as a sole
agent or in combination with other agents such as fentanyl during seizure foci resection
with accurate intraoperative brain mapping.

The hypnotic effect of dexmedetomidine is mediated by the hyperpolarization of noradrenergic
neurons in the locus ceruleus, which proposed that dexmedetomidine converges on a natural
sleep pathway to exert its sedative effect. Venn and co-workers, as part of a large
European multicentre trial investigating dexmedetomidine for postoperative sedation in the
ICU, reported that: "Patients are calmly and easily roused from sleep to allow excellent
communication and cooperation while intubated and ventilated, and then similarly quickly
return to sleep". This unique sedation state is very useful for awake craniotomy, which
requires deep level of sedation during painful operative procedures, as well as easily
rousable state during mapping of eloquent function.

The purpose of this blinded, prospective, randomized study is to compare the efficacy of
dexmedetomidine versus propofol-remifentanil based sedation in patients undergoing awake
craniotomy for resection of tumors. The study hypothesis is that the efficacy of performing
intra-operative brain mapping is identical between dexmedetomidine and the
propofol-remifentanil based sedation. The primary end-points are to assess the ability to
perform intraoperative mapping during awake craniotomy. Secondary end-points will assess the
incidence of complications (respiratory depression, failure to provide adequate analgesia),
as well as patient and surgeon satisfaction to the corresponding anesthetic technique.

Inclusion Criteria:

- Adult patients more than 18 years of age.

- ASA score I, II and III.

- Patients scheduled to undergo awake craniotomy for elective tumor resection.

Exclusion Criteria:

- Patients with allergies to the drugs being used.

- Patients who are pregnant.

- Patients with alcohol or substance abuse.

- Patients who are not able to understand the instructions for an awake craniotomy and
questions regarding intra-operative pain, and post-operative satisfaction.

- Lack of informed consent.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Ability to perform intra-operative mapping during awake craniotomy

Outcome Time Frame:

immediately, intra-operative

Safety Issue:


Principal Investigator

Pirjo Manninen, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Head of Neuroanesthesia, Associate Professor, University Health Network, Department of Anesthesia, University of Toronto, Canada


Canada: Health Canada

Study ID:




Start Date:

November 2012

Completion Date:

November 2013

Related Keywords:

  • Brain Tumor
  • dexmedetomidine
  • conscious sedation
  • awake craniotomy
  • brain mapping
  • Brain Neoplasms