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Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy

NCT02193568 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-03-13

No results posted yet for this study

Summary

This randomized clinical trial studies light sedation compared with intubated general anesthesia (a loss of feeling and a complete loss of awareness that feels like a very deep sleep) in reducing complications and length of hospital stay in patients with brain cancer undergoing craniotomy. Craniotomy is an operation in which a piece of the skull is removed so doctors can remove a brain tumor or abnormal brain tissue. Light sedation allows patients to remain awake during their surgery, while intubated general anesthesia puts patients to sleep. Surgery complication rates may be reduced if intubated general anesthesia is avoided. Additionally, patients not receiving intubated general anesthesia tend to recover more quickly after surgery. It is not yet known whether light sedation is better at reducing complications and length of hospital stay compared to intubated general anesthesia.

Conditions

  • Adult Brain Tumor

Interventions

PROCEDURE

Arm I (light sedation)

If patients experience excessive preoperative anxiety they will receive light sedation of midazolam 1 mg IV.In our standard practice, it is very rare that patients receive anxiolytic premedication for craniotomies, so it is unlikely that many will require midazolam. Two IVs will be placed, one for infusion of meds and one for possible resuscitation.

PROCEDURE

Arm II (intubated general anesthesia)

Receive intubated general anesthesia

PROCEDURE

Arm II (intubated general anesthesia)

Undergo craniotomy

OTHER

Arm II (intubated general anesthesia)

Ancillary studies

PROCEDURE

Arm I (light sedation)

Undergo craniotomy

OTHER

Arm I (light sedation)

Ancillary studies

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • James Elder, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-10-08
Completion
2019-01-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02193568 on ClinicalTrials.gov