The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Outcomes in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Double Blind Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT03370588|
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : June 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: dexmedetomidine Drug: Normal saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind randomized controlled trial|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation|
|Primary Purpose:||Supportive Care|
|Official Title:||The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Outcomes in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Double Blind Randomized Controlled Trial|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
|Experimental: dexmedetomidine infusion group||
Group A: dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum. Group B: Saline infusion during same time period.
|Active Comparator: normal saline infusion group||
Drug: Normal saline
Group B: Saline infusion during same time period.
- IL-6 level [ Time Frame: Up to 12 hours after surgery ]To evaluate the effect of dexmedetomidine on the level of IL-6 in patient undergoing HIPEC, IL-6 level was measured up to 12 hours after surgery.
- recurrence rate [ Time Frame: up to 1 year after surgery ]To evaluate the effect of dexmedetomidine on the recurrence rate up to 1 year after surgery were collected.
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): NCT03370588
|Contact: Na Young Kim, MDemail@example.com|
|Korea, Republic of|
|Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine||Recruiting|
|Seoul, Korea, Republic of, 03722|
|Contact: Na Young Kim, MD 82-10-8871-2786 firstname.lastname@example.org|