Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors

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WITHDRAWN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

Study Start Date

2007-09-30

Study Completion Date

2010-03-31

Brief Summary

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If the anesthetic regimen can influence the serum level of inflammatory cytokines and if the levels of cytokines are related to the incidence of post operative complications, these complications may be a function of the anesthetic method. In an effort to find the best anesthetic regimen for patients undergoing craniotomy for intracranial tumors, the researchers will compare the effect of volatile anesthetic with that of total intravenous anesthesia (TIVA) on cytokine levels. The researchers will also compare the composite incidence of some common major post-operative complications after craniotomy for intracranial malignancy.

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Detailed Description

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This is a randomized blinded clinical trial. Patients will be randomized into one of two groups. One group will receive a volatile anesthetic (sevoflurane)while the other group will receive intravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia.

The anesthesia team will know the result of randomization at induction. Postoperative data will be gathered by research personnel who will be blinded to the anesthetic method used. Patients will be blinded to the anesthetic they receive until after the 4-week outcomes are collected, when they will have the option to be unblinded.

Peripheral blood samples will be taken a total of 7 times; pre-induction to anesthesia, 15 minutes after surgical positioning, after the tumor is extracted, and at 6,12,18, and 24 hours after emergence from anesthesia.

Patients will be called for follow up every week for 4 weeks following discharge.

Conditions

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Brain Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Total Intravenous anesthetic

Intravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia

Group Type ACTIVE_COMPARATOR

Propofol + Remifentanil

Intervention Type DRUG

Administered intravenously during surgery for maintenance of General Anesthesia

Volatile Anesthetic

Inhalational anesthetics (sevoflurane+remifentanil) for maintenance of General Anesthesia. Patients receive Sevoflurane as a volatile anesthetic and remifentanil as an IV agent for maintenance of general anesthesia.

Group Type ACTIVE_COMPARATOR

Sevoflurane + Remifentanil

Intervention Type DRUG

the (Sevoflurane + Remifentanil) arm: Sevoflurane as inhalational agent and Remifentanil as intravenous agent for maintenance of General Anesthesia

Interventions

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Propofol + Remifentanil

Administered intravenously during surgery for maintenance of General Anesthesia

Intervention Type DRUG

Sevoflurane + Remifentanil

the (Sevoflurane + Remifentanil) arm: Sevoflurane as inhalational agent and Remifentanil as intravenous agent for maintenance of General Anesthesia

Intervention Type DRUG

Other Intervention Names

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Intravenous anesthetics Inhalational anesthetics

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing general anesthesia for elective surgical excision of a primary brain tumor
* Age: Older than 18
* New and recurrent cases will be included

Exclusion Criteria

* Patient refusal
* Emergency craniotomy
* Craniotomy after head injuries or intracranial bleeding
* Patients with active inflammatory processes such as infection or immunologic illnesses known to increase baseline immunologic markers
* Preoperative diagnosis of DVT by lower extremity ultrasound or symptoms
* Preoperative pulmonary infiltrative disease (pulmonary fibrosis, sarcoid, etc.)
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No