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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02164448
Other study ID # 4-2014-0249
Secondary ID
Status Completed
Phase Phase 4
First received June 9, 2014
Last updated May 26, 2015
Start date June 2014
Est. completion date January 2015

Study information

Verified date May 2015
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The investigators hypothesized that sympatholytic effect of dexmedetomidine would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. This study is to investigate the effect of intraoperative dexmedetomidine infusion on postoperative bowel movement in patients undergoing laparoscopic gastrectomy.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- patient between 20 and 65 of age with ASA physical status ?-?

- gastric cancer patient undergoing laparoscopic gastrectomy

Exclusion Criteria:

- ASA physical status ?

- bradycardia (< 60 bpm), arrhythmia

- uncompensated heart failure

- hepatic failure (Child-Pugh score B ??)

- renal failure (eGFR MDRD < 60 ml/min/1.73m2)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)


Intervention

Drug:
the dexmedetomidine group
the dexmedetomidine group: dexmedetomidine infusion from induction of anesthesia to end of surgery
the control group
saline infusion from induction of anesthesia to end of surgery

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other soft diet time To evaluate the postoperative bowel movement, we will assess the time to resume soft diet intake up to 1 week No
Primary gas passing To evaluate the postoperative bowel movement, we will assess the time to first gas passing up to 1 week No
Secondary sips of water time To evaluate the postoperative bowel movement, we will assess the time to resume water intake up to 1 week No