DACA: Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery

Sponsor

Zhihong LU (Other)

Overall Status

Completed

CT.gov ID

NCT03355534

Collaborator

(none)

150

Enrollment

Location

Arms

35.8

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Aneurysm Cerebral	Drug: Intravenous dexmedetomidine Drug: nasal dexmedetomidine Drug: intravenous saline Drug: nasal saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect of Dexmedetomidine on Maintenance and Recovery of Cranial Aneurysm Surgery

Actual Study Start Date :

Jan 5, 2018

Actual Primary Completion Date :

Dec 30, 2020

Actual Study Completion Date :

Dec 30, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

incidence of coughing [from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xijing Hospital	Xi'an	Shaanxi	China	710032

Sponsors and Collaborators

Zhihong LU

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhihong LU, clinical professor, Air Force Military Medical University, China

ClinicalTrials.gov Identifier:

NCT03355534

Other Study ID Numbers:

XJH-A-2017-10-10

First Posted:

Nov 28, 2017

Last Update Posted:

May 26, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zhihong LU, clinical professor, Air Force Military Medical University, China

dexmedetomidine

general anesthesia

cerebral aneurysm

Additional relevant MeSH terms:

Intracranial Aneurysm

Aneurysm

Dexmedetomidine

Study Results

No Results Posted as of May 26, 2022