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Completed

NCT Number: NCT03910556

Re-craniotomy and Complications After Elective Neurosurgery

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

intraoperative factors

Other names: surgical duration, operation, blood loss, blood used, fluid volume administration

Primary outcomes

  1. re-craniotomy

    Time frame: the first 24 hours

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

  2. predictive factors of re-craniotomy

    Time frame: the first 24 hours

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

Secondary outcomes

  1. incidence of major non-neurological complications

    Time frame: the first 24 hours

    number of participants who develop any major systemic complications

  2. predictive factors of major non-neurological complications

    Time frame: the first 24 hours

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

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Collaborators

  • Ananchanok Saringkarinkul
  • Patipan Krungsri
  • Prangmalee Leucharussamee
  • Yodying Punjasawadwong

Registry information

Official study title

Predictive Factors of Re-craniotomy and Major Non-neurological Complications in Elective Neurosurgery: A Prospective Cohort Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 10, 2019
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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