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Patient-controlled Versus Anesthesiologist-controlled Propofol-remifentanil in Awake Craniotomy

This study has been withdrawn prior to enrollment.
(Funds needed to carry on the project were not secured.)
Information provided by (Responsible Party):
University Health Network, Toronto Identifier:
First received: October 8, 2009
Last updated: January 7, 2013
Last verified: January 2013
Awake craniotomy for removal of brain tumour is performed because the tumour may be located close to areas of the brain that control specific functions such as movement or speech. Local anaesthesia (freezing) and sedation are required to make the patient comfortable and free of pain, but also to be able to cooperate for testing of brain function (speaking, moving) in order to preserve these areas while removing the brain tumour. The patient will be administered routine anesthetic drugs (sedatives (propofol) and pain killers (remifentanil)). The amount of sedation and analgesia (pain killer) is individually tailored to each patient as each person has different requirements. The usual way to give these medications is by the anesthesiologist assessing pain level, watching the patient and monitoring blood pressure and heart rate. Another way to give this medication is now available. This is with a special device, known as a patient-controlled analgesia pump (PCA). This device allows the patient to push a button to give pain medicine through an intravenous line and is frequently used for pain treatment after surgery and for other types of procedures. This device may be helpful during awake craniotomy, as it would allow patient-controlled administration of pain medicine and relaxing medicine whenever required. The amount of medication can be increased by more presses of the pump. At all times during the operation, the anesthesiologist will monitor the patient.

Condition Intervention
Awake Craniotomy for Brain Tumour Surgery
Procedure: Patient-Controlled Sedation/Analgesia
Procedure: Anesthetist-Controlled Sedation/Analgesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Patient-controlled Versus Anesthesiologist-controlled Propofol-remifentanil in Awake Craniotomy for Tumor Surgery

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To assess the ability of patient-controlled sedation/analgesia remifentanil-propofol to maintain appropriate levels of sedation and analgesia in commensuration with the needs of the surgery at different stages. [ Time Frame: 2 hours, 24 hours ]

Enrollment: 0
Arms Assigned Interventions
Experimental: Patient-Controlled Sedation/Analgesia
Patient controls the amount of sedation and analgesia delivered, according to their own requirements.
Procedure: Patient-Controlled Sedation/Analgesia
Patient controls delivery of sedation and analgesia requirements.
Active Comparator: Anesthetist-Controlled Sedation/Analgesia
Patient sedation and analgesia requirements are delivered by the anesthetist.
Procedure: Anesthetist-Controlled Sedation/Analgesia
All sedation and analgesia requirements are determined and delivered by the attending anesthetist.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adult patients more than 18 years of age
  2. ASA I, II or III
  3. Scheduled to undergo awake craniotomy for elective supratentorial tumor resection.

Exclusion Criteria:

  1. patients with allergy to the drugs being used.
  2. patients at risk for pulmonary aspiration eg patients with history of GERD, gastroparesis (eg diabetic) and obesity.
  3. patients with BMI 35 or above
  4. patients with severe cardiovascular or respiratory diseases (ASA IV or higher).
  5. patients who are pregnant.
  6. patients with alcohol or substance abuse.
  7. patients who could not understand the concept of PCSA.
  8. patients who do not understand and are unable to follow instructions for the study due to a language barrier
  9. lack of informed consent.
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Please refer to this study by its identifier: NCT00992940

Canada, Ontario
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Pirjo Manninen, MD University Health Network, Toronto
  More Information

Responsible Party: University Health Network, Toronto Identifier: NCT00992940     History of Changes
Other Study ID Numbers: 09-0492-A
Study First Received: October 8, 2009
Last Updated: January 7, 2013

Keywords provided by University Health Network, Toronto:
awake craniotomy
patient-controlled sedation analgesia
anesthetist-controlled sedation analgesia
tumour surgery

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents processed this record on April 24, 2017