NCT02753205

Brief Summary

Dexmedetomidine, might attenuate the sympathetic activation and contribute to stable hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine during laparoscopic lower abdominal surgery, might help to attenuate the increment of intracranial pressure and the investigator would observe the optic nerve sheath diameter using ultrasonography.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
withdrawn

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

April 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

April 14, 2016

Last Update Submit

November 8, 2016

Conditions

Intracranial Hypertension

Outcome Measures

Primary Outcomes (1)

  • Optic nerve sheath diameter

    mm

    Change from Baseline optic nerve sheath diameter at pneumoperitoneum 30 min

Secondary Outcomes (1)

  • Respiratory and mean arterial pressure

    Change from Baseline Respiratory and mean arterial pressure at pneumoperitoneum 30 min

Study Arms (2)

Control

EXPERIMENTAL

Infusion of normal saline

Drug: normal saline

Dexmedetomidine

ACTIVE COMPARATOR

infusion of dexmedetomidine 0.5ug/kg/h for 10 min and after that, infusion of dexmedetomidine 0.4ug/kg/h until the end of surgery

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

infusion of dexmedetomidine 0.5ug/kg/h for 10 min and after that, infusion of dexmedetomidine 0.4ug/kg/h until the end of surgery

Also known as: dex
Dexmedetomidine
normal salineDRUG

infusion of normal saline

Also known as: NS
Control

Eligibility Criteria

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

You may qualify if:

  • clinical diagnosis of colorectal cancer
  • planed for laparoscopic low anterior resection

You may not qualify if:

  • morbid obesity (body mass index \> 30 kg.m-2)
  • history of cerebrovascular disease
  • history of respiratory disease
  • uncontrolled cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intracranial Hypertension

Interventions

DexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Kyung Cheon Lee

    Gachon Universtiy Gil Medical Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 27, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

November 10, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share