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Re-craniotomy and Complications After Elective Neurosurgery

Sponsor
Chiang Mai University (Other)
Overall Status
Completed
CT.gov ID
NCT03910556
Collaborator
Yodying Punjasawadwong (Other), Prangmalee Leucharussamee (Other), Ananchanok Saringkarinkul (Other), Patipan Krungsri (Other)
439
Enrollment
25
Actual Duration (Months)

Study Details

Study Description

Brief Summary

This study is a prospective cohort study to find the incidence of re-craniotomy and predictive factors. The secondary outcomes are to find the incidence of major non-neurological complications and predictive factors.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Demographic data include age, gender, preoperative neurological assessment, diagnosis, operation, surgical position, ASA physical status, dexamethasone requirement, anticonvulsant therapy, airway assessment, and blood component reservation.

Intraoperative information contain anesthetic technique, total dosage of propofol, fentanyl, and other anesthetic agents, total blood loss, types and amount of fluid replacement, volume of blood transfusion, latest body temperature, and the ability of safe extubation.

Postoperative complications will be categorized in to general conditions, neurological complications, and systemic problems. General conditions such as on endotracheal tube overnight and postoperative blood transfusion. Neurological complications include worsen increased ICP, intracranial hematoma, seizures, newly-developed motor deficit, cranial nerve palsy, CSF rhinorrhea, and emergency re-craniotomy. Systemic problems are hypothermia, electrolyte imbalance, anemia, hypertension, and hyperglycemia. Postoperative nausea and vomiting and the rescued anti-emetic drugs will be recorded. Postoperative anti-epileptic drug (AED) and pain medication will be collected.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
439 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predictive Factors of Re-craniotomy and Major Non-neurological Complications in Elective Neurosurgery: A Prospective Cohort Study
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Feb 1, 2019
Actual Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm Intervention/Treatment
no complication

the patients who did not develop any kind of complication and no re-craniotomy

Drug: Propofol
intraoperative factors
Other Names:
  • surgical duration
  • operation
  • blood loss
  • blood used
  • fluid volume administration

    		•
    with complication (s)

    the patients who developed at least one of non-neurological complication or required re-craniotomy

    Drug: Propofol
    intraoperative factors
    Other Names:
  • surgical duration
  • operation
  • blood loss
  • blood used
  • fluid volume administration

    		•

    Outcome Measures

    Primary Outcome Measures

    1. re-craniotomy [the first 24 hours]

      number of participants who required re-craniotomy assessed by the neurosurgeon

    2. predictive factors of re-craniotomy [the first 24 hours]

      types of perioperative factors to predict the occurrence of re-craniotomy

    Secondary Outcome Measures

    1. incidence of major non-neurological complications [the first 24 hours]

      number of participants who develop any major systemic complications

    2. predictive factors of major non-neurological complications [the first 24 hours]

      types of predictive factors to predict the occurrence of major non-neurological complications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who are scheduled for elective craniotomy during 2017-2019

    • Patients who are planned for general anesthesia

    • Patients have read the study information and signed in the consent form

    Exclusion Criteria:

    • Patients who are unable to understand and sign in the consent form

    • Patients who are scheduled for minor surgical procedures such as ventriculostomy and VP-shunt

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chiang Mai University
    • Yodying Punjasawadwong
    • Prangmalee Leucharussamee
    • Ananchanok Saringkarinkul
    • Patipan Krungsri

    Investigators

    • Principal Investigator: Pathomporn Pin-on, MD, Chiang Mai University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pathomporn Pin on, M.D., Assistant Professor, Chiang Mai University
    ClinicalTrials.gov Identifier:
    NCT03910556
    Other Study ID Numbers:
    • ANE-2561-05961
    First Posted:
    Apr 10, 2019
    Last Update Posted:
    Apr 12, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pathomporn Pin on, M.D., Assistant Professor, Chiang Mai University
    re-craniotomy
    major non-neurological complications
    neurosurgery
    brain tumors
    Additional relevant MeSH terms:
    Brain Neoplasms
    Propofol

    Study Results

    No Results Posted as of Apr 12, 2019