Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity

Awake craniotomy require a cooperative patient during resection neurosurgery phase. Anesthesiologist should guarantee analgesia, sedation, nausea and vomiting prevention, while maintaining normal vital parameters.

Neurosurgeon could be help by Intraoperative electrocorticography to maximise lesion resection and avoiding neurologic sequelae. Propofol and remifentanyl have been largely used. Dexmedetomidine represents an alternative. However little is known about the role of dexmedetomidine on Intraoperative electrocorticography.

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Key information

Conditions

Craniotomy Cerebral Tumor Dexmedetomidine Nervous System Diseases Neurologic Manifestations Neurophysiology Pathological Conditions, Signs and Symptoms Propofol Remifentanil Seizures Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cristian Deana

Udine, 33100, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

PATIENTS UNDERGOING AWAKE CRANIOTOMY FOR TUMOR RESECTION (EXCLUDED E.G. SURGERY OF EPILEPSIA)
INTRAOPERATIVE MONITORING (IOM) WITH ELECTROCORTICOGRAPHY
AWAKE-AWAKE-AWAKE TECHNIQUE

Exclusion criteria

AGE <18 YEARS OLD
NON AWAKE-AWAKE-AWAKE TECHNIQUE
ABSENCE OF IOM

Treatment and study plan

Propofol

Drug

awake neurosurgery under propofol-remifentanil sedation

Other names: Remifentanil, Dexmedetomidine

Primary outcomes

SEIZURE ACTIVITY

Time frame: DURING TUMOR RESECTION PHASE OF THE AWAKE CRANIOTOMY

INCIDENCE OF ELECTRO-CLINICAL SEIZURE ACTIVITY IN THE TWO GROUPS DURING RESECTIVE PHASE OF AWAKE CRANIOTOMY EVALUATED WITH ELECTROCORTICOGRAPHY.

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria-Universitaria Integrata di Udine

Other

Registry information

Official study title

Propofol-remifentanil Versus Dexmedetomidine in Awake Craniotomy: an Intraoperative Neurophysiological Evaluation

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Nov 2, 2021
Registry last updated: Jan 31, 2023

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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