Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery

NCT ID: NCT03355534

Last Updated: 2022-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-05

Study Completion Date

2020-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aneurysm Cerebral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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nasal dexmedetomidine

dexmedetomidine is given nasally, saline is given intravenously

Group Type EXPERIMENTAL

nasal dexmedetomidine

Intervention Type DRUG

drug is nasally given to patients

intravenous saline

Intervention Type DRUG

saline is given to patients intravenously

intravenous dexmedetomidine

saline is given nasally, dexmedetomidine is given intravenously

Group Type EXPERIMENTAL

Intravenous dexmedetomidine

Intervention Type DRUG

drug is intravenously infused to patients

nasal saline

Intervention Type DRUG

normal saline is given to patients nasally

normal saline

saline is given nasally and intravenously

Group Type PLACEBO_COMPARATOR

intravenous saline

Intervention Type DRUG

saline is given to patients intravenously

nasal saline

Intervention Type DRUG

normal saline is given to patients nasally

Interventions

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Intravenous dexmedetomidine

drug is intravenously infused to patients

Intervention Type DRUG

nasal dexmedetomidine

drug is nasally given to patients

Intervention Type DRUG

intravenous saline

saline is given to patients intravenously

Intervention Type DRUG

nasal saline

normal saline is given to patients nasally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhihong LU

OTHER

Sponsor Role lead

Responsible Party

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Zhihong LU

clinical professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lize Xiong

Role: STUDY_CHAIR

Air Force Military Medical University, China

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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Peng K, Wu S, Liu H, Ji F. Dexmedetomidine as an anesthetic adjuvant for intracranial procedures: meta-analysis of randomized controlled trials. J Clin Neurosci. 2014 Nov;21(11):1951-8. doi: 10.1016/j.jocn.2014.02.023. Epub 2014 Jun 25.

Reference Type RESULT
PMID: 24974190 (View on PubMed)

Soliman RN, Hassan AR, Rashwan AM, Omar AM. Prospective, randomized controlled study to assess the role of dexmedetomidine in patients with supratentorial tumors undergoing craniotomy under general anesthesia. Middle East J Anaesthesiol. 2011 Feb;21(1):23-33.

Reference Type RESULT
PMID: 21991729 (View on PubMed)

Elbakry AE, Ibrahim E. Propofol-dexmedetomidine versus propofol-remifentanil conscious sedation for awake craniotomy during epilepsy surgery. Minerva Anestesiol. 2017 Dec;83(12):1248-1254. doi: 10.23736/S0375-9393.17.11873-0. Epub 2017 Jun 14.

Reference Type RESULT
PMID: 28631453 (View on PubMed)

Jun JH, Kim KN, Kim JY, Song SM. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21.

Reference Type RESULT
PMID: 28639236 (View on PubMed)

Sun Y, Li Y, Sun Y, Wang X, Ye H, Yuan X. Dexmedetomidine Effect on Emergence Agitation and Delirium in Children Undergoing Laparoscopic Hernia Repair: a Preliminary Study. J Int Med Res. 2017 Jun;45(3):973-983. doi: 10.1177/0300060517699467. Epub 2017 Mar 21.

Reference Type RESULT
PMID: 28470100 (View on PubMed)

Other Identifiers

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XJH-A-2017-10-10

Identifier Type: -

Identifier Source: org_study_id

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