NCT02164448

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

June 9, 2014

Last Update Submit

May 26, 2015

Conditions

Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy

Keywords

dexmedetomidinepostoperative bowel movementlaparoscopic gastrectomy

Outcome Measures

Primary Outcomes (1)

  • gas passing

    To evaluate the postoperative bowel movement, we will assess the time to first gas passing

    up to 1 week

Secondary Outcomes (1)

  • sips of water time

    up to 1 week

Other Outcomes (1)

  • soft diet time

    up to 1 week

Study Arms (2)

dexmedetomidine group

EXPERIMENTAL
Drug: the dexmedetomidine group

control group

PLACEBO COMPARATOR
Drug: the control group

Interventions

the dexmedetomidine groupDRUG

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

dexmedetomidine group
the control groupDRUG

saline infusion from induction of anesthesia to end of surgery

control group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅲ
  • gastric cancer patient undergoing laparoscopic gastrectomy

You may not qualify if:

  • ASA physical status Ⅳ
  • bradycardia (\< 60 bpm), arrhythmia
  • uncompensated heart failure
  • hepatic failure (Child-Pugh score B 이상)
  • renal failure (eGFR MDRD \< 60 ml/min/1.73m2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine,

Seoul, Seoul, 120-752, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2014

First Posted

June 16, 2014

Study Start

June 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

KR(1)