Patient-controlled Versus Anesthesiologist-controlled Propofol-remifentanil in Awake Craniotomy
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Purpose
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 Endpoint Classification: Safety/Efficacy Study 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 |
- 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 ] [ Designated as safety issue: Yes ]
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patients more than 18 years of age
- ASA I, II or III
- Scheduled to undergo awake craniotomy for elective supratentorial tumor resection.
Exclusion Criteria:
- patients with allergy to the drugs being used.
- patients at risk for pulmonary aspiration eg patients with history of GERD, gastroparesis (eg diabetic) and obesity.
- patients with BMI 35 or above
- patients with severe cardiovascular or respiratory diseases (ASA IV or higher).
- patients who are pregnant.
- patients with alcohol or substance abuse.
- patients who could not understand the concept of PCSA.
- patients who do not understand and are unable to follow instructions for the study due to a language barrier
- lack of informed consent.
Contacts and Locations| Canada, Ontario | |
| Toronto Western Hospital, University Health Network | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Principal Investigator: | Pirjo Manninen, MD | University Health Network, Toronto |
More Information
No publications provided
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT00992940 History of Changes |
| Other Study ID Numbers: | 09-0492-A |
| Study First Received: | October 8, 2009 |
| Last Updated: | January 7, 2013 |
| Health Authority: | Canada: Canadian Research Ethics Board |
Keywords provided by University Health Network, Toronto:
|
awake craniotomy patient-controlled sedation analgesia anesthetist-controlled sedation analgesia remifentanil-propofol tumour surgery |
Additional relevant MeSH terms:
|
Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Propofol Remifentanil Anesthetics, Intravenous Anesthetics, General |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013