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

A

Azienda Sanitaria-Universitaria Integrata di Udine

Status

Completed

Conditions

Seizures
Neurophysiology
Craniotomy
Propofol
Dexmedetomidine
Remifentanil
Cerebral Tumor

Treatments

Drug: Propofol

Study type

Observational

Funder types

Other

Identifiers

NCT05103735
CRANIO-UDINE

Details and patient eligibility

About

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.

Enrollment

170 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

170 participants in 2 patient groups

PROPOFOL-REMIFENTANYL
Description:
Awake craniotomy under propofol-remifentanil sedation. Propofol and remifentanyl was administered through continuous intravenous infusion, starting 30 minutes prior to surgery. The end of the infusion was at the end of the surgical procedure. Propofol dosage: 0.2-2 mk/kg/h Remifentanyl dosage: 0.01-0.1 mcg/kg/min
Treatment:
Drug: Propofol
DEXMEDETOMIDINE
Description:
Awake craniotomy under dexmedetomidine sedation. Dexmedetomidine was administered through continuous intravenous infusion, starting 30 minutes prior to surgery. The end of the infusion was at the end of the surgical procedure. Dexmedetomidine dosage: 0.2-1 mcg/kg/h In this group, remifentanyl administration was allowed.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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