Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery (DACA)

May 25, 2022 updated by: Zhihong LU

Effect of Dexmedetomidine on Maintenance and Recovery of Cranial Aneurysm Surgery

Dexmedetomidine induces analgesic and sedative effects and is reported to decrease agitation during emergence after general anesthesia in various surgeries. For patients undergoing cranial aneurysm surgeries, a calm anesthesia and emergence is important. In this study, the investigatorstend to observe the effect of dexmedetomidine on maintenance and recovery of patients undergoing cranial aneurysm surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

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

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing cerebral aneurysm embolism under general anesthesia

Exclusion Criteria:

  • patients with bradycardia or atrioventricular heart block
  • patients with ASA(American Society of Anesthesiologists) status over 3
  • patients with body mass index(BMI)≥30kg/m2
  • patients with difficulty in communication
  • patients with ruptured aneurysm
  • patients suspected or proved to be pregnant

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: nasal dexmedetomidine
dexmedetomidine is given nasally, saline is given intravenously
Drug: nasal dexmedetomidine
drug is nasally given to patients
Drug: intravenous saline
saline is given to patients intravenously
EXPERIMENTAL: intravenous dexmedetomidine
saline is given nasally, dexmedetomidine is given intravenously
Drug: Intravenous dexmedetomidine
drug is intravenously infused to patients
Drug: nasal saline
normal saline is given to patients nasally
PLACEBO_COMPARATOR: normal saline
saline is given nasally and intravenously
Drug: intravenous saline
saline is given to patients intravenously
Drug: nasal saline
normal saline is given to patients nasally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of coughing
Time Frame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ricker's agitation-sedation score
Time Frame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
score of coughing
Time Frame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
0=no coughing;1=intermittent coughing;2=continuous coughing
from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
time to response to verbal command
Time Frame: from end of infusing anesthetics to response to verbal command,averagely 20 minutes
from end of infusing anesthetics to response to verbal command,averagely 20 minutes
time to extubation
Time Frame: from end of infusing anesthetics to extubation,averagely 28 minutes
from end of infusing anesthetics to extubation,averagely 28 minutes
blood pressure before and after extubation
Time Frame: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes
blood glucose before and after aneurysm embolism
Time Frame: immediately before inserting coil and after finishing inserting coil,an average of 1 hour
immediately before inserting coil and after finishing inserting coil,an average of 1 hour
blood lactate before and after aneurysm embolism
Time Frame: immediately before inserting coil and after finishing inserting coil,,an average of 1 hour
immediately before inserting coil and after finishing inserting coil,,an average of 1 hour
Mini-mental state examination score
Time Frame: 24 hours after surgery
24 hours after surgery

Collaborators and Investigators

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

Sponsor

Zhihong LU

Investigators

  • Study Chair: Lize Xiong, Air Force Military Medical University, China

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)

January 5, 2018

Primary Completion (ACTUAL)

December 30, 2020

Study Completion (ACTUAL)

December 30, 2020

Study Registration Dates

First Submitted

November 19, 2017

First Submitted That Met QC Criteria

November 22, 2017

First Posted (ACTUAL)

November 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJH-A-2017-10-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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