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

NCT ID: NCT05103735

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-15

Study Completion Date

2021-10-11

Brief Summary

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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.

Detailed Description

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Conditions

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Craniotomy Seizures Dexmedetomidine Propofol Remifentanil Cerebral Tumor Neurophysiology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PROPOFOL-REMIFENTANYL

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

Propofol

Intervention Type DRUG

awake neurosurgery under propofol-remifentanil sedation

DEXMEDETOMIDINE

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.

No interventions assigned to this group

Interventions

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Propofol

awake neurosurgery under propofol-remifentanil sedation

Intervention Type DRUG

Other Intervention Names

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Remifentanil Dexmedetomidine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Sanitaria-Universitaria Integrata di Udine

OTHER

Sponsor Role lead

Responsible Party

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Cristian Deana

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cristian Deana

Udine, , Italy

Site Status

Countries

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Italy

References

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Deana C, Pez S, Ius T, Furlan D, Nilo A, Isola M, De Martino M, Mauro S, Verriello L, Lettieri C, Tomasino B, Valente M, Skrap M, Vetrugno L, Pauletto G. Effect of Dexmedetomidine versus Propofol on Intraoperative Seizure Onset During Awake Craniotomy: A Retrospective Study. World Neurosurg. 2023 Apr;172:e428-e437. doi: 10.1016/j.wneu.2023.01.046. Epub 2023 Jan 20.

Reference Type RESULT
PMID: 36682527 (View on PubMed)

Other Identifiers

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CRANIO-UDINE

Identifier Type: -

Identifier Source: org_study_id

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