Dexmedetomidine on Optic Nerve Sheath Diameter

November 8, 2016 updated by: Hyun Jeong Kwak, Gachon University Gil Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
Infusion of normal saline
Drug: normal saline
infusion of normal saline
Other Names:
  • NS
Active Comparator: Dexmedetomidine
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
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
Other Names:
  • dex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optic nerve sheath diameter
Time Frame: Change from Baseline optic nerve sheath diameter at pneumoperitoneum 30 min
mm
Change from Baseline optic nerve sheath diameter at pneumoperitoneum 30 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory and mean arterial pressure
Time Frame: Change from Baseline Respiratory and mean arterial pressure at pneumoperitoneum 30 min
mmHg
Change from Baseline Respiratory and mean arterial pressure at pneumoperitoneum 30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Investigators

  • Study Chair: Kyung Cheon Lee, Gachon Universtiy Gil Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

April 24, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Estimate)

November 10, 2016

Last Update Submitted That Met QC Criteria

November 8, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCIRB2016-058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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