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Effects of Dexmedetomidine on Delirium After Living Donor Renal Transplantation in Adult Patients

Primary Purpose

Postoperative Delirium After Living Donor Renal Transplantation

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Saline
Sponsored by
Tao Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Delirium After Living Donor Renal Transplantation

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age > 17 and < 60 years;
  • American Society of Anesthesiology (ASA) I-III;
  • admitted for living donor renal transplantation.

Exclusion Criteria:

  • Patients with a history of drug abuse;
  • preoperative history of schizophrenia, epilepsy, parkinsonism, use of cholinesterase inhibitor, inability to communicate in the preoperative period (coma, profound dementia, or language barrier).

Sites / Locations

  • First Affiliated Hospital, Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine

Saline

Arm Description

Dexmedetomidine ivpump 0.2ug/kg/h during living donor renal transplantation.

Saline ivpump 0.2ug/kg/h during living donor renal transplantation.

Outcomes

Primary Outcome Measures

Postoperative Delirium

Secondary Outcome Measures

Full Information

First Posted
July 24, 2015
Last Updated
June 9, 2018
Sponsor
Tao Zhang
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1. Study Identification

Unique Protocol Identification Number
NCT02509949
Brief Title
Effects of Dexmedetomidine on Delirium After Living Donor Renal Transplantation in Adult Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tao Zhang

4. Oversight

5. Study Description

Brief Summary
Delirium, an acute change in mental status, is a serious medical complication among hospitalized patients. Syndrome of delirium involves agitation, sleep disturbance, affective disorders and cognitive disruptions. One vulnerable period for developing delirium is in the postoperative days. Postoperative delirium often initiates a cascade of adverse consequences including an increase in length of stay and hospital costs, and greater mortality. The investigators have observed that the incidence of postoperative delirium in patients after renal transplantation is about 20-30% in our hospital. Several studies have revealed that dexmedetomidine, as a widely used sedative during anesthesia, can decrease the incidence of postoperative delirium after cardiac surgery. The investigators aim to examine whether administration of dexmedetomidine can reduce postoperative delirium after living donor renal transplantation in adult patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium After Living Donor Renal Transplantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Dexmedetomidine ivpump 0.2ug/kg/h during living donor renal transplantation.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline ivpump 0.2ug/kg/h during living donor renal transplantation.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Postoperative Delirium
Time Frame
Postoperative day 1-7.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age > 17 and < 60 years; American Society of Anesthesiology (ASA) I-III; admitted for living donor renal transplantation. Exclusion Criteria: Patients with a history of drug abuse; preoperative history of schizophrenia, epilepsy, parkinsonism, use of cholinesterase inhibitor, inability to communicate in the preoperative period (coma, profound dementia, or language barrier).
Facility Information:
Facility Name
First Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Zhang, Master of Medicine
Phone
13580482938
Email
zhtao98@aliyun.com

12. IPD Sharing Statement

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Effects of Dexmedetomidine on Delirium After Living Donor Renal Transplantation in Adult Patients

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