Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors (TIVA)

NeuroTherapia, Inc.

Status: Withdrawn

Conditions: Brain Neoplasms

Treatments: Drug: Sevoflurane + Remifentanil; Drug: Propofol + Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT00555984

Case 4306

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Total Intravenous anesthetic

Active Comparator group

Description:

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

Treatment:

Drug: Propofol + Remifentanil

Volatile Anesthetic

Active Comparator group

Description:

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.

Treatment:

Drug: Sevoflurane + Remifentanil