NCT06666959

Brief Summary

The goal of this observational study is to learn about the anti-inflammatory effects of anesthetics on patients undergoing endovascular coiling of cerebral aneurysm. The main question it aims to answer is: Does sevoflurane or propofol affect the inflammatory response in subarachnoid hemorrhage? Participants already undergoing endovascular coiling of cerebral aneurysm will have their serum levels of inflammatory factors measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

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

May 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

October 26, 2024

Last Update Submit

October 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Concentration of interleukin-10

    Test the concentration of interleukin-10 of the participants

    From enrollment to 3 months postoperation

Secondary Outcomes (9)

  • Concentration of interleukin-1

    From enrollment to 3 months postoperation

  • Concentration of interleukin-2

    From enrollment to 3 months postoperation

  • Concentration of interleukin-6

    From enrollment to 3 months postoperation

  • Concentration of interleukin-8

    From enrollment to 3 months postoperation

  • Concentration of tumor necrosis factor

    From enrollment to 3 months postoperation

  • +4 more secondary outcomes

Study Arms (1)

patients undergoing endovascular coiling of cerebral aneurysm in Tongji hospital

The present clinical study was carried out with the aim of determine whether the inflammatory effect differs when using propofol or sevoflurane anesthesia.

Drug: Anesthesia Agent

Interventions

intravenous anesthetic and inhalation anesthetic

Also known as: sevoflurane, propofol
patients undergoing endovascular coiling of cerebral aneurysm in Tongji hospital

Eligibility Criteria

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

In Tongji hospital

You may qualify if:

  • Consecutive patients aged 18 years and older presenting to the Tongji hospital for endovascular coiling of cerebral aneurysm were eligible for enrollment.

You may not qualify if:

  • have an endocrine system disease
  • pregnancy
  • have other brain disorders
  • take drugs that alter endocrine hormones
  • receive perioperative blood derivatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Interventions

AnestheticsSevofluranePropofol

Intervention Hierarchy (Ancestors)

Central Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

October 26, 2024

First Posted

October 31, 2024

Study Start

May 1, 2023

Primary Completion

February 8, 2024

Study Completion

May 8, 2024

Last Updated

October 31, 2024

Record last verified: 2024-10

Locations