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

NCT ID: NCT02142595

Last Updated: 2015-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Sleep Quality of Patients Undergoing TURP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type 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

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

Group Type EXPERIMENTAL

Midazolam

Intervention Type 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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants were deemed eligible if they were candidates for spinal anesthesia undergoing TURP
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Wen-fei Tan

the Anesthesiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Ma, M.D.,PhD.

Role: STUDY_DIRECTOR

Department of Anesthesiology the first hospital of CMU

Locations

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the First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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20140515

Identifier Type: -

Identifier Source: org_study_id

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