Sleep Quality of Patients Undergoing TURPPhase 4NCT02142595
Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing TURP
A Phase 4 study testing dexmedetomidine and Midazolam in people with Sleep Quality of Patients Undergoing TURP, run by China Medical University, China at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 60 to 85 years, men only
- Conditions the study is for
- Sleep Quality of Patients Undergoing TURP
- What is being tested?
- dexmedetomidine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants were deemed eligible if they were candidates for spinal anesthesia undergoing TURP
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: Comparison of the Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing Transurethral Prostatic Resection(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.
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
- Being tested
- dexmedetomidine, Midazolam
- Keywords
- dexmedetomidine, midazolam, sleep quality, delirium
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
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
MidazolamDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change of postoperative sleep quality
The bispectral index score (BIS) was monitored during the operation and the first postoperative night
Measured: preoperation, first postoperative night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Quality of Patients Undergoing TURPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-fei Tan, China Medical University, China
- Investigators
- Hong Ma, M.D.,PhD., Study director, Department of Anesthesiology the first hospital of CMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142595
- Sponsor's protocol ID
- 20140515
- Status last verified
- May 2014
- First submitted
- 15 May 2014
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing Transurethral Prostatic Resection(TURP)
- ClinicalTrials.gov ID
- NCT02142595
- Acronym / sponsor ID
- 20140515
- Keywords
- dexmedetomidine, midazolam, sleep quality, delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dexmeditomidine group D | Experimental | Drug: dexmedetomidineThe 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 |
| Midazolam group M | Experimental | Drug: MidazolamThe 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 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 |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants were deemed eligible if they were candidates for spinal anesthesia undergoing TURP
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidineThe 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 | dexmeditomidine group D |
| MidazolamThe 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 M |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
Related trials for Sleep Quality of Patients Undergoing TURP
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Ma, M.D.,PhD. study director
Department of Anesthesiology the first hospital of CMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine and Midazolam in people with Sleep Quality of Patients Undergoing TURP, run by China Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change of postoperative sleep quality (time frame: preoperation, first postoperative night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.