Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery

NCT03355534 | Completed DMC

• 1 other identifier: XJH-A-2017-10-10
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneurysm Cerebral

Keywords

dexmedetomidine; general anesthesia; cerebral aneurysm

Outcome Measures

Primary Outcomes (1)

• incidence of coughing

  from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes

Secondary Outcomes (8)

• 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

• 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

Study Arms (3)

nasal dexmedetomidine

EXPERIMENTAL

dexmedetomidine is given nasally, saline is given intravenously

Drug: nasal dexmedetomidine; Drug: intravenous saline

intravenous dexmedetomidine

EXPERIMENTAL

saline is given nasally, dexmedetomidine is given intravenously

Drug: Intravenous dexmedetomidine; Drug: nasal saline

normal saline

PLACEBO COMPARATOR

saline is given nasally and intravenously

Drug: intravenous saline; Drug: nasal saline

Interventions

Intravenous dexmedetomidine DRUG

drug is intravenously infused to patients

intravenous dexmedetomidine

nasal dexmedetomidine DRUG

drug is nasally given to patients

nasal dexmedetomidine

intravenous saline DRUG

saline is given to patients intravenously

nasal dexmedetomidine; normal saline

nasal saline DRUG

normal saline is given to patients nasally

intravenous dexmedetomidine; normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing cerebral aneurysm embolism under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhihong LU: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (5)

• 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.

  PMID: 24974190 RESULT

• 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.

  PMID: 21991729 RESULT

• 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.

  PMID: 28631453 RESULT

• 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.

  PMID: 28639236 RESULT

• 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.

  PMID: 28470100 RESULT

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lize Xiong

  Air Force Military Medical University, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: November 19, 2017
• First Posted: November 28, 2017
• Study Start: January 5, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)