NCT02509949

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Last Updated

June 12, 2018

Status Verified

June 1, 2018

Enrollment Period

4.3 years

First QC Date

July 24, 2015

Last Update Submit

June 9, 2018

Conditions

Postoperative Delirium After Living Donor Renal Transplantation

Outcome Measures

Primary Outcomes (1)

  • Postoperative Delirium

    Postoperative day 1-7.

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine

Saline

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

DexmedetomidineDRUG
Dexmedetomidine
SalineDRUG
Saline

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

DexmedetomidineSodium Chloride

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Tao Zhang

Study Record Dates

First Submitted

July 24, 2015

First Posted

July 28, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2019

Last Updated

June 12, 2018

Record last verified: 2018-06

Locations

CN(1)