Dexmedetomidine to Improve Outcomes During Emergence From Retroperitoneal Laparoscopic Surgery (DEALS)

May 25, 2022 updated by: Zhihong LU, Air Force Military Medical University, China

Effect of Dexmedetomidine on Outcomes During Emergence From Retroperitoneal Laparoscopic Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Richmond Score
Time Frame: From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour
From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cough score
Time Frame: From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour
From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour
Time to awake
Time Frame: From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour
time to open eyes to verbal command
From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2014

Primary Completion (Actual)

August 12, 2015

Study Completion (Actual)

August 13, 2015

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 10, 2014

First Posted (Estimate)

December 12, 2014

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJH-A-2014-6-22-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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