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CompletedNCT02142595Updated Sep 24, 2015

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

A Phase 4 interventional study of dexmedetomidine and Midazolam in Sleep Quality of Patients Undergoing TURP, sponsored by China Medical University, China. Completed at 1 site in China. Open to male participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-09-24.

Sponsored by China Medical University, China · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
60 Years to 85 Years
Sex
Male
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Sleep Quality of Patients Undergoing TURP

Keywords

  • dexmedetomidine
  • midazolam
  • sleep quality
  • delirium
03

In context

Lead sponsor

China Medical University, China is the lead sponsor of 93 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
111 participants (actual)

Study arms

  • Experimental
    dexmeditomidine group D

    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

  • Experimental
    Midazolam group M

    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

  • No intervention
    group control

    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

  • Drugdexmedetomidine

    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

  • DrugMidazolam

    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

06

What researchers measure

Primary outcomes

  1. The Change of postoperative sleep quality

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

    Time frame: preoperation, first postoperative night

07

Study locations

1 site
  • the First Hospital of China Medical University
    Shenyang, Liaoning 110001, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02142595
Lead sponsor
China Medical University, China
Responsible party
Wen-fei Tan (the Anesthesiology Department, China Medical University, China) — Principal investigator
First posted
May 20, 2014
Start date
May 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Sep 24, 2015

Study contacts

Hong Ma, M.D.,PhD.
study director · Department of Anesthesiology the first hospital of CMU

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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