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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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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Detailed Description

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Conditions

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Awake Craniotomy for Brain Tumour Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Patient-Controlled Sedation/Analgesia

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

Group Type EXPERIMENTAL

Patient-Controlled Sedation/Analgesia

Intervention Type PROCEDURE

Patient controls delivery of sedation and analgesia requirements.

Anesthetist-Controlled Sedation/Analgesia

Patient sedation and analgesia requirements are delivered by the anesthetist.

Group Type ACTIVE_COMPARATOR

Anesthetist-Controlled Sedation/Analgesia

Intervention Type PROCEDURE

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

Interventions

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Patient-Controlled Sedation/Analgesia

Patient controls delivery of sedation and analgesia requirements.

Intervention Type PROCEDURE

Anesthetist-Controlled Sedation/Analgesia

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No