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

Seizures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05103735
• Other study ID #: CRANIO-UDINE
• Status: Completed
• Start date: September 15, 2021
• Est. completion date: October 11, 2021

Study information

• Verified date: January 2023
• Source: Azienda Sanitaria-Universitaria Integrata di Udine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: October 11, 2021
• Est. primary completion date: October 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Propofol
awake neurosurgery under propofol-remifentanil sedation

Locations

Country	Name	City	State
Italy	Cristian Deana	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria-Universitaria Integrata di Udine

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SEIZURE ACTIVITY	INCIDENCE OF ELECTRO-CLINICAL SEIZURE ACTIVITY IN THE TWO GROUPS DURING RESECTIVE PHASE OF AWAKE CRANIOTOMY EVALUATED WITH ELECTROCORTICOGRAPHY.	DURING TUMOR RESECTION PHASE OF THE AWAKE CRANIOTOMY