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

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ClinicalTrials.gov Identifier: NCT02142595
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
Wen-fei Tan, China Medical University, China

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.

Condition or disease Intervention/treatment Phase
Sleep Quality of Patients Undergoing TURP Drug: dexmedetomidine Drug: Midazolam Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of the Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing Transurethral Prostatic Resection(TURP)
Study Start Date : May 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

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
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

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



Primary Outcome Measures :
  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



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142595


Locations
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China, Liaoning
the First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Sponsors and Collaborators
China Medical University, China
Investigators
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Study Director: Hong Ma, M.D.,PhD. Department of Anesthesiology the first hospital of CMU
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Responsible Party: Wen-fei Tan, the Anesthesiology Department, China Medical University, China
ClinicalTrials.gov Identifier: NCT02142595    
Other Study ID Numbers: 20140515
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: May 2014
Keywords provided by Wen-fei Tan, China Medical University, China:
dexmedetomidine
midazolam
sleep quality
delirium
Additional relevant MeSH terms:
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Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents