Comparative Study on the Effects of Epidural Dexmedetomidine on Heart Rate Variability During General Anesthesia in Patients Undergoing Gastrectomy
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|ClinicalTrials.gov Identifier: NCT01857141|
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : February 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg) Drug: normal saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||August 2013|
Drug: preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg)
Patients in the pre-emptive groups recived a dose of 1.5㎍/kg dexmedetomidine dissolved into normal saline 10cc before the induction of
|Placebo Comparator: normal saline||
Drug: normal saline
patients in the control groups received the equivalent volume of normal saline.
- Heart rate variability analysis [ Time Frame: 5min perioids after fluid resuscitation. ]
Heart rate variability analysis was performed according to the Task Force recommendations.
Frequency domain analysis was based on fast Fourier transformation. Power spectrum densities were calculated for low frequencies (LF: 0.04-0.15 Hz) and high frequencies (HF: 0.15-0.4 Hz) informalized units, defined as the LF or HF proportional part of the total power.
Baseline and 30min after the injection of the study drug.
- Epidural injection [ Time Frame: at 30 min after the epidural injection of the study drug ]
And secondary data collection was done at 30 min after the epidural injection of the study drug.
All of the HRV analysis was done before anaesthesia induction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857141
|Korea, Republic of|
|Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea|
|Seoul, Korea, Republic of, 120-752|