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

January 30, 2023 updated by: Cristian Deana, Azienda Sanitaria-Universitaria Integrata di Udine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Udine, Italy, 33100
        • Cristian Deana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ALL PATIENTS UNDERGOING AWAKE CRANIOTOMY FOR TUMOR RESECTION SURGERY

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
awake neurosurgery under propofol-remifentanil sedation
Other Names:
  • Dexmedetomidine
  • Remifentanil
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SEIZURE ACTIVITY
Time Frame: DURING TUMOR RESECTION PHASE OF THE AWAKE CRANIOTOMY
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Sanitaria-Universitaria Integrata di Udine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

October 10, 2021

Study Completion (Actual)

October 11, 2021

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

November 1, 2021

First Posted (Actual)

November 2, 2021

Study Record Updates

Last Update Posted (Actual)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRANIO-UDINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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