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

• Sponsor: Tao Zhang (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02509949
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Delirium After Living Donor Renal Transplantation	Drug: Dexmedetomidine; Drug: Saline	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: May 1, 2015
• Anticipated Primary Completion Date: Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine Dexmedetomidine ivpump 0.2ug/kg/h during living donor renal transplantation.	Drug: Dexmedetomidine
Placebo Comparator: Saline Saline ivpump 0.2ug/kg/h during living donor renal transplantation.	Drug: Saline

Outcome Measures

Primary Outcome Measures

1. Postoperative Delirium [Postoperative day 1-7.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 59 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

• Tao Zhang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tao Zhang, Tao Zhang, First Affiliated Hospital, Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT02509949
• Other Study ID Numbers: DDRT
• First Posted: Jul 28, 2015
• Last Update Posted: Jun 12, 2018
• Last Verified: Jun 1, 2018

• Additional relevant MeSH terms: Delirium; Dexmedetomidine

Study Results

No Results Posted as of Jun 12, 2018