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WithdrawnNCT00992940Updated Jan 9, 2013

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

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 Withdrawn at 1 site in Canada.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

Why this study was withdrawn
Funds needed to carry on the project were not secured.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Awake Craniotomy for Brain Tumour Surgery

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Keywords

  • awake craniotomy
  • patient-controlled sedation analgesia
  • anesthetist-controlled sedation analgesia
  • remifentanil-propofol
  • tumour surgery
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In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

Browse Brain Neoplasms studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Patient-Controlled Sedation/Analgesia

    Patient controls the amount of sedation and analgesia delivered, according to their own requirements.

    Procedure: Patient-Controlled Sedation/Analgesia

  • Active comparator
    Anesthetist-Controlled Sedation/Analgesia

    Patient sedation and analgesia requirements are delivered by the anesthetist.

    Procedure: Anesthetist-Controlled Sedation/Analgesia

Interventions

  • ProcedurePatient-Controlled Sedation/Analgesia

    Patient controls delivery of sedation and analgesia requirements.

  • ProcedureAnesthetist-Controlled Sedation/Analgesia

    All sedation and analgesia requirements are determined and delivered by the attending anesthetist.

06

What researchers measure

Primary outcomes

  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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Study locations

1 site
  • Toronto Western Hospital, University Health Network
    Toronto, Ontario M5T 2S8, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00992940
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Oct 9, 2009
Last update
Jan 9, 2013

Study contacts

Pirjo Manninen, MD
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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