NCT00555984

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

2.5 years

First QC Date

November 7, 2007

Last Update Submit

April 19, 2017

Conditions

Brain Neoplasms

Keywords

Intracranial tumorsInflammatory markersCraniotomyPostoperative complications

Outcome Measures

Primary Outcomes (1)

  • To study inflammatory changes associated with these two different anesthetic techniques

    24 hours post-operatively

Secondary Outcomes (1)

  • Because of the linkage between cytokines, thrombotic disease, tissue inflammation and brain edema, we plan to monitor a composite outcome derived from occurrence of DVT, PE, new neurologic deficit, postoperative infection and respiratory failure

    4 weeks after discharge

Study Arms (2)

Total Intravenous anesthetic

ACTIVE COMPARATOR

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

Drug: Propofol + Remifentanil

Volatile Anesthetic

ACTIVE COMPARATOR

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.

Drug: Sevoflurane + Remifentanil

Interventions

Propofol + RemifentanilDRUG

Administered intravenously during surgery for maintenance of General Anesthesia

Also known as: Intravenous anesthetics
Total Intravenous anesthetic
Sevoflurane + RemifentanilDRUG

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

Also known as: Inhalational anesthetics
Volatile Anesthetic

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Brain NeoplasmsPostoperative Complications

Interventions

PropofolRemifentanilAnesthetics, IntravenousSevoflurane

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnesthetics, GeneralAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Rafi Avitsian, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Armin Schubert, MD, MBA

    The Cleveland Clinic

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 9, 2007

Study Start

September 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 20, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Study terminated early

Locations

US(1)