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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05103735
Enrollment
170
Registered
2021-11-02
Start date
2021-09-15
Completion date
2021-10-11
Last updated
2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Tumor, Craniotomy, Dexmedetomidine, Neurophysiology, Propofol, Remifentanil, Seizures

Brief summary

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.

Interventions

DRUGPropofol

awake neurosurgery under propofol-remifentanil sedation

Sponsors

Azienda Sanitaria-Universitaria Integrata di Udine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SEIZURE ACTIVITYDURING TUMOR RESECTION PHASE OF THE AWAKE CRANIOTOMYINCIDENCE OF ELECTRO-CLINICAL SEIZURE ACTIVITY IN THE TWO GROUPS DURING RESECTIVE PHASE OF AWAKE CRANIOTOMY EVALUATED WITH ELECTROCORTICOGRAPHY.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026