NCT05103735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

25 days

First QC Date

October 21, 2021

Last Update Submit

January 30, 2023

Conditions

CraniotomySeizuresDexmedetomidinePropofolRemifentanilCerebral TumorNeurophysiology

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Drug: Propofol

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.

Interventions

PropofolDRUG

awake neurosurgery under propofol-remifentanil sedation

Also known as: Remifentanil, Dexmedetomidine
PROPOFOL-REMIFENTANYL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ALL PATIENTS UNDERGOING AWAKE CRANIOTOMY FOR TUMOR RESECTION SURGERY

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cristian Deana

Udine, 33100, Italy

Location

Related 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 Retrospective Study. World Neurosurg. 2023 Apr;172:e428-e437. doi: 10.1016/j.wneu.2023.01.046. Epub 2023 Jan 20.

    PMID: 36682527RESULT

MeSH Terms

Conditions

Seizures

Interventions

PropofolRemifentanilDexmedetomidine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolesAzoles

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2021

First Posted

November 2, 2021

Study Start

September 15, 2021

Primary Completion

October 10, 2021

Study Completion

October 11, 2021

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations

IT(1)