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CompletedNCT03355534DACAUpdated May 26, 2022

Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery

An interventional study of Intravenous dexmedetomidine and nasal dexmedetomidine in Aneurysm Cerebral, sponsored by Zhihong LU. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-26.

Sponsored by Zhihong LU · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Aneurysm Cerebral

Keywords

  • dexmedetomidine
  • general anesthesia
  • cerebral aneurysm
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients undergoing cerebral aneurysm embolism under general anesthesia

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    nasal dexmedetomidine

    dexmedetomidine is given nasally, saline is given intravenously

    Drug: nasal dexmedetomidine · Drug: intravenous saline

  • Experimental
    intravenous dexmedetomidine

    saline is given nasally, dexmedetomidine is given intravenously

    Drug: Intravenous dexmedetomidine · Drug: nasal saline

  • Placebo comparator
    normal saline

    saline is given nasally and intravenously

    Drug: intravenous saline · Drug: nasal saline

Interventions

  • DrugIntravenous dexmedetomidine

    drug is intravenously infused to patients

  • Drugnasal dexmedetomidine

    drug is nasally given to patients

  • Drugintravenous saline

    saline is given to patients intravenously

  • Drugnasal saline

    normal saline is given to patients nasally

05

What researchers measure

Primary outcomes

  1. incidence of coughing

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

Secondary outcomes

  1. Ricker's agitation-sedation score

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

  2. score of coughing

    0=no coughing;1=intermittent coughing;2=continuous coughing

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

  3. time to response to verbal command

    Time frame: from end of infusing anesthetics to response to verbal command,averagely 20 minutes

  4. time to extubation

    Time frame: from end of infusing anesthetics to extubation,averagely 28 minutes

  5. blood pressure before and after extubation

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

  6. blood glucose before and after aneurysm embolism

    Time frame: immediately before inserting coil and after finishing inserting coil,an average of 1 hour

  7. blood lactate before and after aneurysm embolism

    Time frame: immediately before inserting coil and after finishing inserting coil,,an average of 1 hour

  8. Mini-mental state examination score

    Time frame: 24 hours after surgery

06

Study locations

1 site
  • Xijing Hospital
    Xi'an, Shaanxi 710032, China
07

References and documents

Publications

  • 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. PubMed 24974190 ↗
  • 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. PubMed 21991729 ↗
  • 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. PubMed 28631453 ↗
  • 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. PubMed 28639236 ↗
  • 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. PubMed 28470100 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03355534
Lead sponsor
Zhihong LU
Responsible party
Zhihong LU (clinical professor, Air Force Military Medical University, China) — Sponsor-investigator
First posted
Nov 28, 2017
Start date
Jan 5, 2018
Primary completion
Dec 30, 2020
Completion
Dec 30, 2020
Last update
May 26, 2022

Study contacts

Lize Xiong
study chair · Air Force Military Medical University, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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