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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00992940
Recruitment Status : Withdrawn (Funds needed to carry on the project were not secured.)
First Posted : October 9, 2009
Last Update Posted : January 9, 2013
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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 or disease Intervention/treatment Phase
Awake Craniotomy for Brain Tumour Surgery Procedure: Patient-Controlled Sedation/Analgesia Procedure: Anesthetist-Controlled Sedation/Analgesia Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Patient-controlled Versus Anesthesiologist-controlled Propofol-remifentanil in Awake Craniotomy for Tumor Surgery

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Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: University Health Network, Toronto Identifier: NCT00992940     History of Changes
Other Study ID Numbers: 09-0492-A
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: January 9, 2013
Last Verified: January 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