- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00564603
Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy (DTMPCA)
April 17, 2008 updated by: Nanjing Medical University
Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy
Dexamethasone has been recognized as an antiemetic agent after surgeries, and the combination of dexamethasone and tramadol remained stable in solution up to 5 days.
In addition, i.v.
basal infusion of tramadol is a certified technique in postoperative pain management.
We purposed that combined administration of dexamethasone and tramadol adjunct to i.v.
morphine is an effective way in treating postoperative pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
300
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
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210004
- Nanjing Maternal and Child Care Hospital
-
-
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
17 years to 62 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- ASA physical status I-II
- Chinese
- 19-64yr
- Uterus myoma
Exclusion Criteria:
- Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
- Participants younger than 18yr,older than 65yr or pregnancy was eliminated.
- Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study.
- Those who were not willing to or could not finish the whole study at any time.
- Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Saline with same volume added to tramadol infusion combined with morphine PCA.
|
Saline, in same volume of 2mL
|
Active Comparator: 2
Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA.
|
Dexamethasone, 10mg, continuously infused up to 48h after surgeries.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual analog scale (VAS) of pain
Time Frame: 0-48h after surgeries
|
0-48h after surgeries
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients;
Time Frame: 0-48h after surgeries
|
0-48h after surgeries
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
August 1, 2007
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
November 26, 2007
First Submitted That Met QC Criteria
November 26, 2007
First Posted (Estimate)
November 28, 2007
Study Record Updates
Last Update Posted (Estimate)
April 21, 2008
Last Update Submitted That Met QC Criteria
April 17, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Perceptual Disorders
- Agnosia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Dexamethasone 21-phosphate
Other Study ID Numbers
- NMU-2579-5FW
- 06NMUZ028
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.
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