Postoperative Sedation,Gastrectomy, Enhanced Recovery After SurgeryNCT02674737
Evaluation of the Effect of Appropriate Sedation for Patients After Gastrectomy: A Prospective Randomised Controlled Study
A study testing dexmedetomidine, tramadol and flurbiprofen and tramadol and flurbiprofen in people with Postoperative Sedation,Gastrectomy, Enhanced Recovery After 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 gastrectomy. Prospective randomised controlled study was conducted from October 2015 and December 2015 among patients after gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Sedation,Gastrectomy, Enhanced Recovery After 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
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to May 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-85 years old
- underwent gastrectomy 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, 1 recruiting
- Recruiting
Institute of General Surgery of Jinling Hospital
Nanjing, Jiangsu, 210002
Wenkui Yu, Ph.D., 13701582986, yudrnj@163.com
About this study
To evaluate the efficacy and safety of appropriate postoperative sedation with dexmedetomidine for patients after gastrectomy. Prospective randomised controlled study was conducted from October 2015 and December 2015 among patients after gastrectomy. The investigators are going to 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 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 sedative and analgesic(dexmedetomidine, tramadol and flurbiprofen) are applied to this group of patients. Receives: Drug: dexmedetomidine, tramadol and flurbiprofen |
| Tramadol and flurbiprofen | Active comparator | Only routine analgesic(tramadol and flurbiprofen) are applied to 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
assessed by Prince Henry Pain Scale by investigators at 8:00 am after surgeries until discharge from ICU
Measured: 1-3d after gastrectomy
recovery of gastrointestinal function assessed by time to first defecation after surgery
assessed by time to first defecation after surgery
Measured: 30 days after gastrectomy
white blood cell count (10^9/L)
evaluate postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after gastrectomy
Measured: 1-3d after gastrectomy
C-reactive protein (mg/L)
evaluate postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after gastrectomy
Measured: 1-3d after gastrectomy
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, the target range is -2 to +1
Measured: 1-3d after gastrectomy
risk of bradycardia requiring interventions
heart rate <40/min is considered bradycardia
Measured: 1-3d after gastrectomy
risk of hypotension requiring interventions
systolic blood pressure <80 mmHg or/and diastolic blood pressure <50 mmHg is considered hypotension
Measured: 1-3d after gastrectomy
use of opioids and use of benzodiazepins
Measured: 1-3d after gastrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sedation,Gastrectomy, Enhanced Recovery After 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
- 80 participants (estimated)
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
- NCT02674737
- Sponsor's protocol ID
- Jinling37ICUCMH
- Status last verified
- Jan 2016
- First submitted
- 21 Jan 2016
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Main results and conclusion will be available
Study at a glance
From the registry record, last updated by the sponsor on 4 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 Gastrectomy: A Prospective Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT02674737
- Acronym / sponsor ID
- Jinling37ICUCMH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- Jan 2016
- Primary completion
- May 2016 (estimated)
- First posted
- 4 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 gastrectomy. Prospective randomised controlled study was conducted from October 2015 and December 2015 among patients after gastrectomy. The investigators are going to 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 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 sedative and analgesic(dexmedetomidine, tramadol and flurbiprofen) are applied to this group of patients. |
| Tramadol and flurbiprofen | Active comparator | Drug: tramadol and flurbiprofenOnly routine analgesic(tramadol and flurbiprofen) are applied to this group of patients. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-85 years old
- underwent gastrectomy 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 assessed by Prince Henry Pain Scale
Time frame: 1-3d after gastrectomy
assessed by Prince Henry Pain Scale by investigators at 8:00 am after surgeries until discharge from ICU
recovery of gastrointestinal function assessed by time to first defecation after surgery
Time frame: 30 days after gastrectomy
assessed by time to first defecation after surgery
white blood cell count (10^9/L)
Time frame: 1-3d after gastrectomy
evaluate postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after gastrectomy
C-reactive protein (mg/L)
Time frame: 1-3d after gastrectomy
evaluate postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after gastrectomy
4 secondary outcomes
percentage of time within target sedation range
Time frame: 1-3d after gastrectomy
risk of bradycardia requiring interventions
Time frame: 1-3d after gastrectomy
risk of hypotension requiring interventions
Time frame: 1-3d after gastrectomy
use of opioids and use of benzodiazepins
Time frame: 1-3d after gastrectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Individual participant dataSharing planned: Yes. Main results and conclusion will be available
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, tramadol and flurbiprofen and tramadol and flurbiprofen in people with Postoperative Sedation,Gastrectomy, Enhanced Recovery After 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: status not confirmed, as of the sponsor's last update on 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minhua Cheng, M.D. (15951813384, cmhnju@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain assessed by Prince Henry Pain Scale (time frame: 1-3d after gastrectomy). 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 4 Feb 2016.