Morphine ConsumptionNCT04454515
The Effect of Intraoperative Dexmedetomidine on Postoperative Morphine Requirements After Breast Cancer Surgery
A study testing Dexmedetomidine in people with Morphine Consumption, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous reports, dexmedetomidine improves smoothness of postoperative recovery and reduces intraoperatory imflammatory responses. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Morphine Consumption
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Apr 2021to 1 Jul 2025
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who fulfill the criteria of breast cancer under general anesthesia.
Who cannot join
- Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.
- Patients who have the risk of difficult ventilation or intubation.
- Pregnant women.
- Coagulopathy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Cancer Center
Taipei, 106
Yajung cheng
About this study
Official title: The Effect of Intraoperative Dexmedetomidine on Postoperative Morphine Requirements and Oral Intake After Breast Cancer Surgery
Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous reports, dexmedetomidine improves smoothness of postoperative recovery and reduces intraoperatory imflammatory responses. As patients receiving breast surgeries are especially vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated complications were concerned for not only comfortness but also postoperative oral intake and discharge. The invetigators aimed to compare the effects of dexmedetomidine infusion versus placebo on postoperative narcotics requirement, complications, and oral intake.
Read the detailed description
Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous reports, dexmedetomidine improves smoothness of postoperative recovery and reduces intraoperatory imflammatory responses. As patients receiving breast surgeries are especially vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated complications were concerned for not only comfortness but also postoperative oral intake and discharge.
The invetigators aimed to compare the effects of dexmedetomidine infusion versus placebo on postoperative narcotics requirement, complications, and oral intake.
The participantss under general anesthesia and aged from 30 to 65 years old will be enrolled. All subjects were randomized into the dexmedetomidine or placebo group. They received placebo (group P, n = 30) or dexmedetomidine (loading dose of 1 μg kg-1 followed by 0.5 μg kg-1 h-1) (group D, n = 30) to the end of surgery.
Data collected included intraoperative and postoperative opioid consumption. Postoperative questionare including PONV, Pain intensity, I-FEED questionnaire. Prospective analysis will be performed on the prospectively collected data.
We expected to examine if intraoperative dexmedetomidine decreases the postoperative opioid consumption and associated complications, and enhances the gastrointestinal recovery and oral intake with narcotic-sparing effect.
- Conditions
- Morphine Consumption
- Being tested
- Dexmedetomidine, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous reports, dexmedetomidine improves smoothness of postoperative recovery and reduces intraoperatory imflammatory responses. As patients receiving breast surgeries are especially vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated complications were concerned for not only comfortness but also postoperative oral intake and discharge.
placeboDrug
normal saline infusion
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | patient recieving dexmedetomidine Receives: Drug: Dexmedetomidine |
| placebo | Placebo comparator | patients receiving placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
postoperative morphine consumption by mg
Measured: postoperative 7 days
Secondary outcomes (1)
i-feed score
recovery of eating by I-feed questionare ( score: 0-14), minimum 0 (complete recovery without eating problems), maximum 14
Measured: up to postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start20 Apr 2021
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morphine ConsumptionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group is going to receive precedex and another is placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454515
- Sponsor's protocol ID
- 202004120MINB
- Status last verified
- Jan 2023
- First submitted
- 29 Jun 2020
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to the ethical concern, we did not share our paatients' data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Dexmedetomidine on Postoperative Morphine Requirements and Oral Intake After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT04454515
- Acronym / sponsor ID
- 202004120MINB
- Conditions
- Morphine Consumption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 1 Jul 2020 (actual)
- 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.
Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous reports, dexmedetomidine improves smoothness of postoperative recovery and reduces intraoperatory imflammatory responses. As patients receiving breast surgeries are especially vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated complications were concerned for not only comfortness but also postoperative oral intake and discharge. The invetigators aimed to compare the effects of dexmedetomidine infusion versus placebo on postoperative narcotics requirement, complications, and oral intake.
Detailed description
Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous reports, dexmedetomidine improves smoothness of postoperative recovery and reduces intraoperatory imflammatory responses. As patients receiving breast surgeries are especially vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated complications were concerned for not only comfortness but also postoperative oral intake and discharge.
The invetigators aimed to compare the effects of dexmedetomidine infusion versus placebo on postoperative narcotics requirement, complications, and oral intake.
The participantss under general anesthesia and aged from 30 to 65 years old will be enrolled. All subjects were randomized into the dexmedetomidine or placebo group. They received placebo (group P, n = 30) or dexmedetomidine (loading dose of 1 μg kg-1 followed by 0.5 μg kg-1 h-1) (group D, n = 30) to the end of surgery.
Data collected included intraoperative and postoperative opioid consumption. Postoperative questionare including PONV, Pain intensity, I-FEED questionnaire. Prospective analysis will be performed on the prospectively collected data.
We expected to examine if intraoperative dexmedetomidine decreases the postoperative opioid consumption and associated complications, and enhances the gastrointestinal recovery and oral intake with narcotic-sparing effect.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- one group is going to receive precedex and another is placebo.
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: Dexmedetomidinepatient recieving dexmedetomidine |
| placebo | Placebo comparator | Drug: placebopatients receiving placebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who fulfill the criteria of breast cancer under general anesthesia.
Key exclusion criteria (4 listed)
- Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.
- Patients who have the risk of difficult ventilation or intubation.
- Pregnant women.
- Coagulopathy.
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous reports, dexmedetomidine improves smoothness of postoperative recovery and reduces intraoperatory imflammatory responses. As patients receiving breast surgeries are especially vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated complications were concerned for not only comfortness but also postoperative oral intake and discharge. | Drug | dexmedetomidine |
| placebonormal saline infusion | Drug | placebo |
Primary outcome
morphine consumption
Time frame: postoperative 7 days
postoperative morphine consumption by mg
1 secondary outcome
i-feed score
Time frame: up to postoperative day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No. due to the ethical concern, we did not share our paatients' data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Morphine Consumption, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Jung Cheng, MD,PhD (23220322, chengyj@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morphine consumption (time frame: postoperative 7 days). 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 17 Jan 2024.