Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing TURP

NCT02142595 | Completed Phase 4 DMC

• 1 other identifier: 20140515
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators designed a study to determine whether dexmedetomidine versus midazolam combined with spinal anesthesia would provide same postoperative sleep quality in patients undergoing transurethral prostatic resection.

Conditions

Sleep Quality of Patients Undergoing TURP

Keywords

dexmedetomidine; midazolam; sleep quality; delirium

Outcome Measures

Primary Outcomes (1)

• The Change of postoperative sleep quality

  The bispectral index score (BIS) was monitored during the operation and the first postoperative night

  preoperation, first postoperative night

Study Arms (3)

dexmeditomidine group D

EXPERIMENTAL

The sedative solution was prepared as a 10µg /ml dexmedetomidine in an unlabeled 20ml syringe. The sedative solution administered intravenously started at rate of kg (weight of patient)\*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)\*0.15 ml/h through syringe pump to the end of surgery

Drug: dexmedetomidine

Midazolam group M

EXPERIMENTAL

The sedative solution was prepared as a 0.375mg/ml midazolam or normal saline in an unlabeled 20ml syringe. The sedative solution administered intravenously started at rate of kg (weight of patient)\*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)\*0.15 ml/h through syringe pump to the end of surgery

Drug: Midazolam

group control

NO INTERVENTION

normal saline in an unlabeled 20ml syringe. The sedative solution administered intravenously started at rate of kg (weight of patient)\*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)\*0.15 ml/h through syringe pump to the end of surgery

Interventions

dexmedetomidine DRUG

The sedative solution administered intravenously started at rate of kg (weight of patient)\*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)\*0.15 ml/h through syringe pump to the end of surgery

dexmeditomidine group D

Midazolam DRUG

The sedative solution administered intravenously started at rate of kg (weight of patient)\*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)\*0.15 ml/h through syringe pump to the end of surgery

Midazolam group M

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants were deemed eligible if they were candidates for spinal anesthesia undergoing TURP

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Delirium

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hong Ma, M.D.,PhD.

  Department of Anesthesiology the first hospital of CMU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the Anesthesiology Department

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 20, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 24, 2015

Record last verified: 2014-05

Locations

CN (1)