NCT02275247

Brief Summary

To investigate whether stellate ganglion block is helpful to brain protection during cranial aneurysm surgery

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

October 20, 2014

Last Update Submit

May 19, 2016

Conditions

Intracranial Aneurysm

Keywords

Stellate ganglion blockAneurysm surgeryCognitive recoveryCerebral vasospasm

Outcome Measures

Primary Outcomes (1)

  • The incidence of cerebral vasospasm

    The occurrence of cerebral vasospasm will be diagnosed by using of the transcranial doppler instrument.

    Change from baseline at 2hour,6hour,1day,3day,and 7day after aneurysm surgery

Secondary Outcomes (3)

  • Perioperative cerebral oxygen metabolism

    Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively

  • The difference of plasma endothelin, melatonin, and S100-β protein level between two groups at each time point

    Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively

  • Postoperative cognitive function

    Change from baseline at 2hour,6hour,1day,3day,and 7day after aneurysm surgery

Other Outcomes (1)

  • The postoperative recovery quality

    Change from baseline at 2hour,6hour,1day,3day,and 7day postoperatively

Study Arms (2)

Intervention 'Stellate Ganglion Block'

EXPERIMENTAL

Experimental patients will receive a stellate ganglion block with 0.25% ropivacaine 6-8mL on the right side at the level of the sixth cervical vertebrae (C6) before surgery.Then the catheter will be attached to a single use patient-controlled analgesia pump containing 0.2% ropivacaine 150 mL, which will be infused at 2 mL/h.

Drug: Stellate Ganglion Block

without 'Stellate Ganglion Block'

NO INTERVENTION

In the control group, every thing will be conducted as a matter of routine without intervention.

Interventions

Stellate Ganglion BlockDRUG

stellate ganglion block will be administered using either 6-8mL saline (Group 1) or 0.25% ropivacaine 6-8mL (Group 2)

Also known as: Local anesthesia with low concentration ropivacaine
Intervention 'Stellate Ganglion Block'

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • aneurysm subarachnoid hemorrhage patients scheduled for cranial aneurysm surgery，
  • ASA grade：Ⅱ-Ⅲ，
  • Hunt～Hess grade :Ⅰ-Ⅲ,
  • have a informed consent.

You may not qualify if:

  • history of mental illness，
  • local infection who can't do stellate ganglion block，
  • pregnant or lactating，
  • nausea cancer or diabetes，
  • participated the study or other related research in the last 30 days，
  • unruptured aneurysms patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Conditions

Intracranial AneurysmVasospasm, Intracranial

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Xu Wang

    Gereral Hospital of Ningxia Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2014

First Posted

October 27, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2016

Last Updated

May 20, 2016

Record last verified: 2016-05

Locations

CN(1)