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NCT Number: NCT02142595

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

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.

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Key information

Conditions

Sleep Quality of Patients Undergoing TURP Confusion Delirium Dyssomnias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

60 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • The exclusion criteria were body mass index exceeding 30 kg/m2, preoperative Pittsburgh Sleep Quality Index global scores higher than 6, anesthesia time longer than 3 hours, allergy to drugs used in the study and treatment with sedatives and analgesics during the postoperative BIS-Vista monitoring period.

Treatment and study plan

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

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

Primary outcomes

  1. The Change of postoperative sleep quality

    Time frame: preoperation, first postoperative night

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

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Official study title

Comparison of the Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing Transurethral Prostatic Resection(TURP)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 20, 2014
Registry last updated
Sep 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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