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This study has been withdrawn prior to enrollment.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.)
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00992940
First received: October 8, 2009
Last updated: January 7, 2013
Last verified: January 2013
  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

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 ] [ 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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992940

Locations
Canada, Ontario
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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 July 26, 2014