Back to results

Dexmedetomidine on Optic Nerve Sheath Diameter

Primary Purpose

Intracranial Hypertension

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Dexmedetomidine

normal saline

About this trial

This is an interventional supportive care trial for Intracranial Hypertension

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

clinical diagnosis of colorectal cancer
planed for laparoscopic low anterior resection

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Control

Dexmedetomidine

Arm Description

Infusion of normal saline

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

Outcomes

Primary Outcome Measures

Optic nerve sheath diameter

Secondary Outcome Measures

Respiratory and mean arterial pressure

mmHg

Full Information

NCT ID

NCT02753205

First Posted

April 14, 2016

Last Updated

November 8, 2016

Sponsor

Gachon University Gil Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02753205

Brief Title

Dexmedetomidine on Optic Nerve Sheath Diameter

Official Title

Effect of Dexmedetomidine on Optic Nerve Sheath Diameter During Laparoscopic Anterior Resection

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Withdrawn

Study Start Date

April 2016 (undefined)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gachon University Gil Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Laparoscopic lower abdominal surgery requires the Trendelenburg position with pneumoperitoneum for a prolonged time, but this can cause significant increase in intracranial pressure. Dexmedetomidine, a selective alpha2 receptor agonist 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracranial Hypertension

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Experimental

Arm Description

Infusion of normal saline

Arm Title

Dexmedetomidine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

dex

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

normal saline

Other Intervention Name(s)

Intervention Description

infusion of normal saline

Primary Outcome Measure Information:

Title

Optic nerve sheath diameter

Description

Time Frame

Change from Baseline optic nerve sheath diameter at pneumoperitoneum 30 min

Secondary Outcome Measure Information:

Title

Respiratory and mean arterial pressure

Description

mmHg

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: clinical diagnosis of colorectal cancer planed for laparoscopic low anterior resection Exclusion Criteria: morbid obesity (body mass index > 30 kg.m-2) history of cerebrovascular disease history of respiratory disease uncontrolled cardiovascular disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyung Cheon Lee

Organizational Affiliation

Gachon Universtiy Gil Medical Center

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Dexmedetomidine on Optic Nerve Sheath Diameter

We'll reach out to this number within 24 hrs