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

NCT ID: NCT02509949

Last Updated: 2018-06-12

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Delirium After Living Donor Renal Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dexmedetomidine

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Saline

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Interventions

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Dexmedetomidine

Intervention Type DRUG

Saline

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tao Zhang

OTHER

Sponsor Role lead

Responsible Party

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Tao Zhang

Tao Zhang

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Tao Zhang, Master of Medicine

Role: primary

13580482938

Other Identifiers

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DDRT

Identifier Type: -

Identifier Source: org_study_id

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