Patient-controlled Versus Anesthesiologist-controlled Propofol-remifentanil in Awake Craniotomy
Primary Purpose
Awake Craniotomy for Brain Tumour Surgery
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Patient-Controlled Sedation/Analgesia
Anesthetist-Controlled Sedation/Analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Awake Craniotomy for Brain Tumour Surgery focused on measuring awake craniotomy, patient-controlled sedation analgesia, anesthetist-controlled sedation analgesia, remifentanil-propofol, tumour surgery
Eligibility Criteria
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.
Sites / Locations
- Toronto Western Hospital, University Health Network
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patient-Controlled Sedation/Analgesia
Anesthetist-Controlled Sedation/Analgesia
Arm Description
Patient controls the amount of sedation and analgesia delivered, according to their own requirements.
Patient sedation and analgesia requirements are delivered by the anesthetist.
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00992940
First Posted
October 8, 2009
Last Updated
January 7, 2013
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00992940
Brief Title
Patient-controlled Versus Anesthesiologist-controlled Propofol-remifentanil in Awake Craniotomy
Official Title
A Comparison of Patient-controlled Versus Anesthesiologist-controlled Propofol-remifentanil in Awake Craniotomy for Tumor Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Funds needed to carry on the project were not secured.
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Awake Craniotomy for Brain Tumour Surgery
Keywords
awake craniotomy, patient-controlled sedation analgesia, anesthetist-controlled sedation analgesia, remifentanil-propofol, tumour surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient-Controlled Sedation/Analgesia
Arm Type
Experimental
Arm Description
Patient controls the amount of sedation and analgesia delivered, according to their own requirements.
Arm Title
Anesthetist-Controlled Sedation/Analgesia
Arm Type
Active Comparator
Arm Description
Patient sedation and analgesia requirements are delivered by the anesthetist.
Intervention Type
Procedure
Intervention Name(s)
Patient-Controlled Sedation/Analgesia
Intervention Description
Patient controls delivery of sedation and analgesia requirements.
Intervention Type
Procedure
Intervention Name(s)
Anesthetist-Controlled Sedation/Analgesia
Intervention Description
All sedation and analgesia requirements are determined and delivered by the attending anesthetist.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pirjo Manninen, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
12. IPD Sharing Statement
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Patient-controlled Versus Anesthesiologist-controlled Propofol-remifentanil in Awake Craniotomy
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