Postoperative Sedation, Abdominal SurgeryNCT02670954
Evaluation of the Effect of Appropriate Sedation for Patients After Abdominal Surgeries : A Prospective Randomised Controlled Study
A study testing Dexmedetomidine, tramadol and flurbiprofen and tramadol and flurbiprofen in people with Postoperative Sedation, Abdominal Surgery, run by Chinese Medical Association at 1 site in China.
Trial summary
To evaluate the efficacy and safety of appropriate postoperative sedation with dexmedetomidine for patients after abdominal surgeries.Prospective randomised controlled study was conducted among patients after abdominal surgeries began in October 2015.The investigators enroll patients who received abdominal surgeries. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Postoperative Sedation, Abdominal Surgery
- What is being tested?
- Dexmedetomidine, tramadol and flurbiprofen and tramadol and flurbiprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Jan 2016
- 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 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16-85 years old
- underwent abdominal surgeries including enterectomy, gastrectomy, hepatectomy and pancreatectomy in the hospital and operation duration lasted at least 2 hours.
Who cannot join
- take part in other clinical trials
- quinolone antibiotics intake 4 weeks prior to or within the study
- NSAIDS intake within one month
- history of peptic ulcer
- respiratory insufficiency
- renal insufficiency
Show all 13Show fewer
- acute hepatitis or severe liver disease (Child-Pugh class C)
- pregnancy or lactation
- abnormal ECG with clinical significance
- uncontrolled hypotension
- bleeding tendency or hematological diseases
- untreated mechanical intestinal obstruction
- unable to express or any kind of mental disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of General Surgery of Jinling Hospital
Nanjing, Jiangsu, 210002
About this study
To evaluate the efficacy and safety of appropriate postoperative sedation with dexmedetomidine for patients after abdominal surgeries.Prospective randomised controlled study was conducted among patients after abdominal surgeries began in October 2015.The investigators enroll patients who received abdominal surgeries. One group receive sedative along with analgesic and the other group analgesic only for the other group on the first 24 hours after surgeries and will follow up for 3 days.
- Being tested
- Dexmedetomidine, tramadol and flurbiprofen, tramadol and flurbiprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine, tramadol and flurbiprofenDrug
tramadol and flurbiprofenDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine,tramadol and flurbiprofen | Experimental | Both routine analgesic and sedation(dexmedetomidine,tramadol and flurbiprofen) are applied for this group of patients. Receives: Drug: Dexmedetomidine, tramadol and flurbiprofen |
| Tramadol and flurbiprofen | Active comparator | Only routine analgesic(Tramadol and flurbiprofen) is applied for this group of patients. Receives: Drug: tramadol and flurbiprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
assessed by Prince Henry Pain Scale by investigators at 8:00 am after surgeries until discharge from ICU
Measured: 1-3d after abdominal surgeries
recovery of gastrointestinal function
assessed by time to first defecation
Measured: from admission to 30 days after abdominal surgeries
white blood cell count(10^9 /L)
evaluation of postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after surgeries
Measured: 1-3d after abdominal surgeries
C-reactive protein(mg/L)
evaluation of postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after surgeries
Measured: 1-3d after abdominal surgeries
Secondary outcomes (4)
percentage of time within target sedation range
assessed by Richmond Agitation-Sedation Scale by investigators at 8:00 am after surgeries until discharge from ICU, target range is -2 to +1
Measured: 1-3d after abdominal surgeries
risk of hypotension requiring interventions
systolic blood pressure <80 mmHg or/and diastolic blood pressure <50 mmHg is considered hypotension
Measured: 1-3d after abdominal surgeries
risk of bradycardia requiring interventions
heart rate <40/min is considered bradycardia
Measured: 1-3d after abdominal surgeries
use of opioids and use of benzodiazepins
Measured: 1-3d after abdominal surgeries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sedation, Abdominal SurgeryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Juanhong Shen, Chinese Medical Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670954
- Sponsor's protocol ID
- Jinling37ICU
- Status last verified
- Jan 2016
- First submitted
- 21 Jan 2016
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: basic characteristics of participant,interventions, primary and secondary outcomes, main results
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Appropriate Sedation for Patients After Abdominal Surgeries : A Prospective Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT02670954
- Acronym / sponsor ID
- Jinling37ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Feb 2016 (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.
To evaluate the efficacy and safety of appropriate postoperative sedation with dexmedetomidine for patients after abdominal surgeries.Prospective randomised controlled study was conducted among patients after abdominal surgeries began in October 2015.The investigators enroll patients who received abdominal surgeries. One group receive sedative along with analgesic and the other group analgesic only for the other group on the first 24 hours after surgeries and will follow up for 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine,tramadol and flurbiprofen | Experimental | Drug: Dexmedetomidine, tramadol and flurbiprofenBoth routine analgesic and sedation(dexmedetomidine,tramadol and flurbiprofen) are applied for this group of patients. |
| Tramadol and flurbiprofen | Active comparator | Drug: tramadol and flurbiprofenOnly routine analgesic(Tramadol and flurbiprofen) is applied for this group of patients. |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 16-85 years old
- underwent abdominal surgeries including enterectomy, gastrectomy, hepatectomy and pancreatectomy in the hospital and operation duration lasted at least 2 hours.
Key exclusion criteria (13 listed)
- take part in other clinical trials
- quinolone antibiotics intake 4 weeks prior to or within the study
- NSAIDS intake within one month
- history of peptic ulcer
- respiratory insufficiency
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, tramadol and flurbiprofen | Drug | Dexmedetomidine,tramadol and flurbiprofen |
| tramadol and flurbiprofen | Drug | Tramadol and flurbiprofen |
Primary outcome
postoperative pain
Time frame: 1-3d after abdominal surgeries
assessed by Prince Henry Pain Scale by investigators at 8:00 am after surgeries until discharge from ICU
recovery of gastrointestinal function
Time frame: from admission to 30 days after abdominal surgeries
assessed by time to first defecation
white blood cell count(10^9 /L)
Time frame: 1-3d after abdominal surgeries
evaluation of postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after surgeries
C-reactive protein(mg/L)
Time frame: 1-3d after abdominal surgeries
evaluation of postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after surgeries
4 secondary outcomes
percentage of time within target sedation range
Time frame: 1-3d after abdominal surgeries
risk of hypotension requiring interventions
Time frame: 1-3d after abdominal surgeries
risk of bradycardia requiring interventions
Time frame: 1-3d after abdominal surgeries
use of opioids and use of benzodiazepins
Time frame: 1-3d after abdominal surgeries
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 Feb 2016.
- Individual participant dataSharing planned: Yes. basic characteristics of participant,interventions, primary and secondary outcomes, main results
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.
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, tramadol and flurbiprofen and tramadol and flurbiprofen in people with Postoperative Sedation, Abdominal Surgery, run by Chinese Medical Association 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 2 inclusion and 13 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 Feb 2016. 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.
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?
postoperative pain (time frame: 1-3d after abdominal surgeries). The study lists 4 primary outcomes in all. 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 2 Feb 2016.