An interventional study of Patient-Controlled Sedation/Analgesia and Anesthetist-Controlled Sedation/Analgesia in Awake Craniotomy for Brain Tumour Surgery, sponsored by University Health Network, Toronto. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-09.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
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.
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Exclusion Criteria:
Patient controls the amount of sedation and analgesia delivered, according to their own requirements.
Procedure: Patient-Controlled Sedation/Analgesia
Patient sedation and analgesia requirements are delivered by the anesthetist.
Procedure: Anesthetist-Controlled Sedation/Analgesia
Patient controls delivery of sedation and analgesia requirements.
All sedation and analgesia requirements are determined and delivered by the attending anesthetist.
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
This study is withdrawn, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto