- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02142595
Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing TURP
September 22, 2015 updated by: Wen-fei Tan, China Medical University, China
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
111
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110001
- The First Hospital of China Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
preoperation, first postoperative night
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hong Ma, M.D.,PhD., Department of Anesthesiology the first hospital of CMU
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
May 15, 2014
First Submitted That Met QC Criteria
May 19, 2014
First Posted (Estimate)
May 20, 2014
Study Record Updates
Last Update Posted (Estimate)
September 24, 2015
Last Update Submitted That Met QC Criteria
September 22, 2015
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Midazolam
- Dexmedetomidine
Other Study ID Numbers
- 20140515
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep Quality of Patients Undergoing TURP
-
Federal University of São PauloCompletedRelationship Between Quality of Life, Self-image and Oral Health in Patients Undergoing HemodialysisPatients Undergoing HemodialysisBrazil
-
University Hospital OstravaCompleted
-
Johann Wolfgang Goethe University HospitalCompletedPatients Undergoing Any Kind of SurgeryGermany
-
Inje UniversityCompletedEnd Tidal Carbon Dioxide of Patients Undergoing General AnesthesiaKorea, Republic of
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCancer Patients Undergoing Stem Cell Transplantation (RCT of ACP for Transplant)
-
Cairo UniversityNorhan Abdelaleem Ali; Ahmed Shaker Ragab; Yasmina sayed Abdrabo IsmaelCompletedComparing of 2 Different Volumes in ESPB in Patients Undergoing MRMEgypt
-
Stiftung Institut fuer HerzinfarktforschungCompletedConsecutive Patients Undergoing Computed Tomography of the Heart for Clinical IndicationsGermany
-
Universitair Ziekenhuis BrusselCompletedSpontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing IUIBelgium
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruitingPatients Undergoing DMEK With a History of Anterior or Posterior Segment Surgery
-
Istituto Oncologico Veneto IRCCSFondazione Guido BerlucchiCompletedNeoplasms Undergoing ChemotherapyItaly
Clinical Trials on dexmedetomidine
-
Cairo UniversityUnknownSpinal Anesthesia DurationEgypt
-
Guangzhou Women and Children's Medical CenterCompletedAmbulatory Surgical ProceduresChina
-
The First Affiliated Hospital with Nanjing Medical...CompletedPostoperative Pain | Breast Feeding | Analgesia ObstetricalChina
-
Seoul National University Bundang HospitalCompleted
-
Guangzhou General Hospital of Guangzhou Military...CompletedPharmacodynamic InteractionChina
-
University Hospital DubravaRecruitingAortic Valve Stenosis | Systemic Inflammatory ResponseCroatia
-
Guangzhou General Hospital of Guangzhou Military...Completed
-
First Affiliated Hospital, Sun Yat-Sen UniversityUnknownArteriovenous MalformationChina
-
Guangzhou General Hospital of Guangzhou Military...UnknownCombined Spinal-epidural AnesthesiaChina
-
Eye & ENT Hospital of Fudan UniversityCompletedAgitated; State, Acute Reaction to StressChina