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Dexmedetomidine on Optic Nerve Sheath Diameter

NCT ID: NCT02753205

Last Updated: 2016-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Intracranial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Infusion of normal saline

Group Type EXPERIMENTAL

normal saline

Intervention Type DRUG

infusion of normal saline

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

normal saline

infusion of normal saline

Intervention Type DRUG

Other Intervention Names

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dex NS

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hyun Jeong Kwak

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyung Cheon Lee

Role: STUDY_CHAIR

Gachon Universtiy Gil Medical Center

Other Identifiers

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GCIRB2016-058

Identifier Type: -

Identifier Source: org_study_id