Clincosm LogoSign in Get a demo

DEALS: Dexmedetomidine to Improve Outcomes During Emergence From Retroperitoneal Laparoscopic Surgery

Sponsor
Air Force Military Medical University, China (Other)
Overall Status
Completed
CT.gov ID
NCT02316236
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
8.1
Actual Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Dexmedetomidine on Outcomes During Emergence From Retroperitoneal Laparoscopic Surgery
Actual Study Start Date :
Dec 10, 2014
Actual Primary Completion Date :
Aug 12, 2015
Actual Study Completion Date :
Aug 13, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: dexmedetomidine loading dose

dexmedetomidine is given at load dose

Drug: dexmedetomidine
an alpha-2 receptor agonist
Other Names:
  • dex

    • Other: loading dose
    0.8ug/kg of dexmedetomidine is given in 10 minutes
    Other Names:
  • LD

    		•
    Experimental: dexmedetomidine sustaining dose

    dexmedetomidine is given at sustaining dose

    Drug: dexmedetomidine
    an alpha-2 receptor agonist
    Other Names:
  • dex

    • Other: sustaining dose
    0.4ug/kg/min of dexmedetomidine is given
    Other Names:
  • SD

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Richmond Score [From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour]

    Secondary Outcome Measures

    1. Cough score [From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour]

    2. Time to awake [From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour]

      time to open eyes to verbal command

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Air Force Military Medical University, China

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhihong LU, Dr, Air Force Military Medical University, China
    ClinicalTrials.gov Identifier:
    NCT02316236
    Other Study ID Numbers:
    • XJH-A-2014-6-22-01
    First Posted:
    Dec 12, 2014
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Additional relevant MeSH terms:
    Dexmedetomidine

    Study Results

    No Results Posted as of May 26, 2022