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NCT02316236 Clinical Trial

Dexmedetomidine to Improve Outcomes During Emergence From Retroperitoneal Laparoscopic Surgery

Anesthesia Clinical Trial

— DEALS  

Official title:
Effect of Dexmedetomidine on Outcomes During Emergence From Retroperitoneal Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02316236
Other study ID # XJH-A-2014-6-22-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 10, 2014
Est. completion date August 13, 2015

Study information
Verified date May 2022
Source Air Force Military Medical University, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is to observe whether dexmedetomidine could reduce agitation during emergence from general anesthesia in patients undergoing retroperitoneal laparoscopic surgery.

Description:

Agitation during emergence is frequent after retroperitoneal urologic surgery. Dexmedetomidine is alpha-2 receptor agonist which shows sedative and algesic effect. In this study we will compare the effect of dexmedetomidine given by different protocols on emergence agitation.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date August 13, 2015
Est. primary completion date August 12, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients scheduled for retroperitoneal laparoscopic surgery - Patients with written informed consent Exclusion Criteria: - Patients with difficulty of communication - Patients with risk of obstructive sleeping apnea syndrome

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• dexmedetomidine
an alpha-2 receptor agonist
Other:
• loading dose
0.8ug/kg of dexmedetomidine is given in 10 minutes
• sustaining dose
0.4ug/kg/min of dexmedetomidine is given

Locations
Country Name City State
China Xijing Hospital Xi'an Shaanxi

Sponsors (1)
Lead Sponsor Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (3)

Ibacache ME, Muñoz HR, Brandes V, Morales AL. Single-dose dexmedetomidine reduces agitation after sevoflurane anesthesia in children. Anesth Analg. 2004 Jan;98(1):60-63. doi: 10.1213/01.ANE.0000094947.20838.8E. — View Citation

Kim SY, Kim JM, Lee JH, Song BM, Koo BN. Efficacy of intraoperative dexmedetomidine infusion on emergence agitation and quality of recovery after nasal surgery. Br J Anaesth. 2013 Aug;111(2):222-8. doi: 10.1093/bja/aet056. Epub 2013 Mar 22. — View Citation

Yang S, Lee H. A dose-finding study of preoperative intravenous dexmedetomidine in children's emergence delirium after epiblepharon surgery. Eur J Ophthalmol. 2014 May-Jun;24(3):417-23. doi: 10.5301/ejo.5000396. Epub 2013 Nov 29. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Richmond Score From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour
Secondary Cough score From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour
Secondary Time to awake time to open eyes to verbal command From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour
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