Analgesia, Patient-ControlledPhase 4NCT00800826
The Combination Effect of Dexmedetomidine and Morphine in Postoperative Patient-Controlled Analgesia
A Phase 4 study testing dexmedetomidine in people with Analgesia, Patient-Controlled and Analgesia, Postoperative, run by National Taiwan University Hospital.
Trial summary
This study was designed to examine the analgesic and side effects of dexmedetomidine-morphine mixture for intravenous patient-controlled analgesia (PCA). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia, Patient-Controlled, Analgesia, Postoperative
- What is being tested?
- dexmedetomidine
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Apr 2008
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who sign informed consent to receive general anesthesia and postoperative analgesia with a PCA device
- Age between 18-65 y/o
- ASA physical status I-III
- Scheduled surgical procedures: gynecological surgery (vaginal or abdominal total hysterectomy), general surgery (gastrectomy, hepatectomy, colon cancer) , orthopedic (spinal fusion or total knee placement), or neurosurgical (cervical decompression)
Who cannot join
- Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders, or drug abuse (include opioids, NSAIDs, sedatives, antidepressants).
- Use of sedatives, analgesics, antiemetics, or antipruritics within 24 hours before operation.
- Patients with definite diagnosis of esophageal reflux syndrome.
- Patients with the probability to be pregnant.
- Intraoperative fentanyl use > 6 μg/kg.
- Patients with significant bradycardia (HR < 60/min) and hypotension (SBP < 90mmHg) after the surgery.
- The duration of surgery is longer than 6 hours.
About this study
This study was designed to examine the analgesic and side effects of dexmedetomidine-morphine mixture for intravenous patient-controlled analgesia (PCA).
Read the detailed description
Patient-controlled analgesia (PCA) is a widely accepted method to control postoperative pain. Morphine is the commonest opioid for PCA, however its side effects are troublesome. Morphine-related side effects include pruritus, nausea, vomiting, constipation, urinary retention, respiratory depression, and sedation. Many studies had been conducted to reduce the side effect of morphine. The current trend of reducing morphine side effect is direct combination of other drugs and morphine in PCA. The advantages of this method are convenient in clinical use and preventive for side effects. Dexmedetomidine is a highly selec¬tive α2-adrenergic receptor agonist that has been reported to cause sedative effects and reduce opioid requirements in the perioperative period. The main advantage of this drug is that it does not cause serious respiratory side effects. The analgesic, sedative/hypnotic and anxiolytic prop¬erties of dexmedetomidine make this drug potentially useful for postoperative sedation and analgesia. No previous study had investigated the effect of direct combination of dexmedetomidine and morphine in PCA. The goal of this study is to investigate the combination effect of dexmedetomidine and morphine in postoperative patient-controlled analgesia.
- Being tested
- dexmedetomidine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startNov 2006
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, Patient-ControlledStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800826
- Sponsor's protocol ID
- 950910
- Status last verified
- Dec 2008
- First submitted
- 1 Dec 2008
- Last updated
- 2 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination Effect of Dexmedetomidine and Morphine in Postoperative Patient-Controlled Analgesia
- ClinicalTrials.gov ID
- NCT00800826
- Acronym / sponsor ID
- 950910
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Apr 2008 (actual)
- First posted
- 2 Dec 2008 (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.
This study was designed to examine the analgesic and side effects of dexmedetomidine-morphine mixture for intravenous patient-controlled analgesia (PCA).
Detailed description
Patient-controlled analgesia (PCA) is a widely accepted method to control postoperative pain. Morphine is the commonest opioid for PCA, however its side effects are troublesome. Morphine-related side effects include pruritus, nausea, vomiting, constipation, urinary retention, respiratory depression, and sedation. Many studies had been conducted to reduce the side effect of morphine. The current trend of reducing morphine side effect is direct combination of other drugs and morphine in PCA. The advantages of this method are convenient in clinical use and preventive for side effects. Dexmedetomidine is a highly selec¬tive α2-adrenergic receptor agonist that has been reported to cause sedative effects and reduce opioid requirements in the perioperative period. The main advantage of this drug is that it does not cause serious respiratory side effects. The analgesic, sedative/hypnotic and anxiolytic prop¬erties of dexmedetomidine make this drug potentially useful for postoperative sedation and analgesia. No previous study had investigated the effect of direct combination of dexmedetomidine and morphine in PCA. The goal of this study is to investigate the combination effect of dexmedetomidine and morphine in postoperative patient-controlled analgesia.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who sign informed consent to receive general anesthesia and postoperative analgesia with a PCA device
- Age between 18-65 y/o
- ASA physical status I-III
- Scheduled surgical procedures: gynecological surgery (vaginal or abdominal total hysterectomy), general surgery (gastrectomy, hepatectomy, colon cancer) , orthopedic (spinal fusion or total knee placement), or neurosurgical (cervical decompression)
Key exclusion criteria (7 listed)
- Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders, or drug abuse (include opioids, NSAIDs, sedatives, antidepressants).
- Use of sedatives, analgesics, antiemetics, or antipruritics within 24 hours before operation.
- Patients with definite diagnosis of esophageal reflux syndrome.
- Patients with the probability to be pregnant.
- Intraoperative fentanyl use > 6 μg/kg.
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 |
|---|---|---|
| dexmedetomidine | Drug | – |
Primary outcome
Not reported in the source record.
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 2 Dec 2008.
Related trials for Analgesia, Patient-Controlled
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
WATER IV PCa (AS Sub-study)
Localized Prostate Cancer
RecruitingEarly Phase 1
Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications.
Substance Use Disorder (SUD)
Not yet recruiting
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery
Breast Cancer, Lymph Node Dissection
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine in people with Analgesia, Patient-Controlled and Analgesia, Postoperative, run by National Taiwan University Hospital.
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 4 inclusion and 7 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 2 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
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 2 Dec 2008.