NCT01987648

Brief Summary

Regarding the postoperative care strategies following elective craniotomy procedures there is little evidence. Many neurosurgical departments prefer these patients to remain intubated and sedated for many hours postoperatively to minimize hemodynamic and respiratory distress in fear of early postoperative complications such as rebleeding or seizures. In this prospective observational study the investigators aim to show that early tracheal extubation following elective brain surgery is feasible and safe.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,969

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

December 8, 2021

Status Verified

December 1, 2021

Enrollment Period

9.9 years

First QC Date

November 12, 2013

Last Update Submit

December 7, 2021

Conditions

CraniotomyPostoperative Complications

Keywords

CraniotomyPostoperative complicationsPerioperative carePostoperative intracerebral hemorrhagePostoperative seizure

Outcome Measures

Primary Outcomes (1)

  • Morbidity

    48 hours postoperative

Secondary Outcomes (5)

  • Re-Intubation

    48 hours postoperative

  • Mortality

    30 Days

  • Emergency CT Scan

    48 hours postoperative

  • Re Operation

    48 hours postoperative

  • Length of postoperative stay on ICU and IMC

    30 Days

Study Arms (1)

All study participants

Included are all patients who 18 years or older, who get an elective craniotomy (no biopsy, no awake surgery, no re-operation) and who are treated at the Department of Neurosurgery

Procedure: Elective Craniotomy Patients

Interventions

Elective Craniotomy PatientsPROCEDURE

Patients who receive an elective craniotomy (no biopsy, no awake surgery, no re-operation)

All study participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who 18 years or older,who get an elective craniotomy (no biopsy, no awake surgery, no re-operation) and who are treated at the Department of Neurosurgery

You may qualify if:

  • Years and older
  • Elective craniotomy for any mass lesion or vascular lesion
  • Early extubation

You may not qualify if:

  • Biopsy only
  • Re-operation
  • Craniotomy due to infection
  • Awake surgery/craniotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Berne, Department of Neurosurgery

Bern, 3018, Switzerland

Location

Related Publications (12)

  • Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anesthesiology. 2000 Jul;93(1):48-54. doi: 10.1097/00000542-200007000-00012.

    PMID: 10861145BACKGROUND

  • Fadul C, Wood J, Thaler H, Galicich J, Patterson RH Jr, Posner JB. Morbidity and mortality of craniotomy for excision of supratentorial gliomas. Neurology. 1988 Sep;38(9):1374-9. doi: 10.1212/wnl.38.9.1374.

    PMID: 3412585BACKGROUND

  • Flint AC, Manley GT, Gean AD, Hemphill JC 3rd, Rosenthal G. Post-operative expansion of hemorrhagic contusions after unilateral decompressive hemicraniectomy in severe traumatic brain injury. J Neurotrauma. 2008 May;25(5):503-12. doi: 10.1089/neu.2007.0442.

    PMID: 18346002BACKGROUND

  • Fukamachi A, Koizumi H, Nagaseki Y, Nukui H. Postoperative extradural hematomas: computed tomographic survey of 1105 intracranial operations. Neurosurgery. 1986 Oct;19(4):589-93. doi: 10.1227/00006123-198610000-00013.

    PMID: 3785596BACKGROUND

  • Fukamachi A, Koizumi H, Nukui H. Postoperative intracerebral hemorrhages: a survey of computed tomographic findings after 1074 intracranial operations. Surg Neurol. 1985 Jun;23(6):575-80. doi: 10.1016/0090-3019(85)90006-0.

    PMID: 3992457BACKGROUND

  • Gerald AG. Update on hemostasis: neurosurgery. Surgery. 2007 Oct;142(4 Suppl):S55-60. doi: 10.1016/j.surg.2007.06.030.

    PMID: 18019938BACKGROUND

  • Kalfas IH, Little JR. Postoperative hemorrhage: a survey of 4992 intracranial procedures. Neurosurgery. 1988 Sep;23(3):343-7. doi: 10.1227/00006123-198809000-00010.

    PMID: 3226512BACKGROUND

  • Merriman E, Bell W, Long DM. Surgical postoperative bleeding associated with aspirin ingestion. Report of two cases. J Neurosurg. 1979 May;50(5):682-4. doi: 10.3171/jns.1979.50.5.0682.

    PMID: 430164BACKGROUND

  • Morgan MK, Johnston IH, Hallinan JM, Weber NC. Complications of surgery for arteriovenous malformations of the brain. J Neurosurg. 1993 Feb;78(2):176-82. doi: 10.3171/jns.1993.78.2.0176.

    PMID: 8421199BACKGROUND

  • Palmer JD, Sparrow OC, Iannotti F. Postoperative hematoma: a 5-year survey and identification of avoidable risk factors. Neurosurgery. 1994 Dec;35(6):1061-4; discussion 1064-5. doi: 10.1227/00006123-199412000-00007.

    PMID: 7885549BACKGROUND

  • Schar RT, Tashi S, Branca M, Soll N, Cipriani D, Schwarz C, Pollo C, Schucht P, Ulrich CT, Beck J, Z'Graggen WJ, Raabe A. How safe are elective craniotomies in elderly patients in neurosurgery today? A prospective cohort study of 1452 consecutive cases. J Neurosurg. 2020 Apr 24;134(3):1113-1121. doi: 10.3171/2020.2.JNS193460. Print 2021 Mar 1.

    PMID: 32330879DERIVED

  • Schar RT, Fiechter M, Z'Graggen WJ, Soll N, Krejci V, Wiest R, Raabe A, Beck J. No Routine Postoperative Head CT following Elective Craniotomy--A Paradigm Shift? PLoS One. 2016 Apr 14;11(4):e0153499. doi: 10.1371/journal.pone.0153499. eCollection 2016.

    PMID: 27077906DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ralph Schär, MD

    Department of Neurosurgery, Inselspital Berne

    PRINCIPAL INVESTIGATOR

  • Jürgen Beck, Prof.

    Department of Neurosurgery, Inselspital Berne

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 19, 2013

Study Start

November 1, 2011

Primary Completion

September 28, 2021

Study Completion

October 1, 2021

Last Updated

December 8, 2021

Record last verified: 2021-12

Locations

CH(1)