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A Comparison of Patient-controlled Versus Anesthesiologist-controlled Propofol-remifentanil in Awake Craniotomy for Tumor Surgery


N/A
18 Years
N/A
Not Enrolling
Both
Awake Craniotomy for Brain Tumour Surgery

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Trial Information

A Comparison of Patient-controlled Versus Anesthesiologist-controlled Propofol-remifentanil in Awake Craniotomy for Tumor Surgery


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 hours, 24 hours

Safety Issue:

Yes

Principal Investigator

Pirjo Manninen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto

Authority:

Canada: Canadian Research Ethics Board

Study ID:

09-0492-A

NCT ID:

NCT00992940

Start Date:

Completion Date:

Related Keywords:

  • Awake Craniotomy for Brain Tumour Surgery
  • awake craniotomy
  • patient-controlled sedation analgesia
  • anesthetist-controlled sedation analgesia
  • remifentanil-propofol
  • tumour surgery
  • Brain Neoplasms

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