Comparison of Dexmedetomidine and Propofol-Remifentanil Conscious Sedation for Awake Craniotomy for Tumor Surgery

NCT01545297 | Completed

• 1 other identifier: 11-0607-A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. Most of the anesthetic agents are associated with some respiratory depression. The anesthetic agent called dexmedetomidine is a potent, highly selective α2-adrenoceptor agonist. The effects of dexmedetomidine are anxiolysis, analgesia, sedation and sympatholysis, and it is not associated with respiratory depressive effect. Bekker et al. first reported the successful use of dexmedetomidine in awake craniotomy in 2001. 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.

Conditions

Brain Tumor

Keywords

dexmedetomidine; conscious sedation; awake craniotomy; brain mapping

Outcome Measures

Primary Outcomes (1)

• Ability to perform intra-operative mapping during awake craniotomy

  immediately, intra-operative

Secondary Outcomes (2)

• Incidence of complications (respiratory depression, failure to provide adequate analgesia)

  intra-operatively, 2h post-operatively, 24h post-operatively

• Patient and surgeon satisfaction to the corresponding anesthetic technique

  intra-opeartively, 2h post-operatively, 24h post-operatively

Study Arms (2)

Propofol-Remifentanil

ACTIVE COMPARATOR

Group I. (propofol/remifentanil): Infusions begin at remifentanil (0.01-0.1 mcg/kg/min) and propofol (25-250 mcg/kg/min) for 15 min, and then titrated to effect.

Drug: Propofol; Drug: Remifentanil

Dexmedetomidine

EXPERIMENTAL

Group II. (dexmedetomidine): The infusion begins at 0.3-0.4 mcg/kg/hr for 15 min, and then titrated down to 0.1-0.2 mcg/kg/hr.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

The infusion begins at dexmedetomidine 0.3-0.4 mcg/kg/hr for 15 min, and then titrated down to 0.1-0.2 mcg/kg/hr.

Also known as: Precedex (TM)

Dexmedetomidine

Propofol DRUG

The infusion begins at propofol 25-250 mcg/kg/min for 15 min, and then titrated to effect.

Also known as: Diprivan (TM)

Propofol-Remifentanil

Remifentanil DRUG

The infusion begins at remifentanil 0.01-0.1 mcg/kg/min for 15 min, and then titrated to effect.

Also known as: Ultiva (TM)

Propofol-Remifentanil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients more than 18 years of age.
• ASA score I, II and III.
• Patients scheduled to undergo awake craniotomy for elective tumor resection.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nicolai Goettel: lead

Study Sites (1)

UHN Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (25)

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  PMID: 27099154 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Dexmedetomidine; Propofol; Remifentanil

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines

Study Officials

• Pirjo Manninen, MD, FRCPC

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

  PRINCIPAL INVESTIGATOR

• Nicolai Goettel, MD

  University Health Network, Department of Anesthesia, University of Toronto, Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 6, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 7, 2016

Record last verified: 2016-07

Locations

CA (1)