Institute of General Surgery of Jinling Hospital
Nanjing, Jiangsu, 210002, China
Completed
NCT Number: NCT02670954
Evaluation of the Effect of Appropriate Sedation for Patients After Abdominal Surgeries : A Prospective Randomised Controlled 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.
Completed
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Conditions
Age range
16 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 16-85 years old
- underwent abdominal surgeries including enterectomy, gastrectomy, hepatectomy and pancreatectomy in the hospital and operation duration lasted at least 2 hours.
Exclusion criteria
- 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
- 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.
Treatment and study plan
Dexmedetomidine, tramadol and flurbiprofen
Drugtramadol and flurbiprofen
DrugPrimary outcomes
-
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
Secondary outcomes
-
percentage of time within target sedation range
Time frame: 1-3d after abdominal surgeries
assessed by Richmond Agitation-Sedation Scale by investigators at 8:00 am after surgeries until discharge from ICU, target range is -2 to +1
-
risk of hypotension requiring interventions
Time frame: 1-3d after abdominal surgeries
systolic blood pressure <80 mmHg or/and diastolic blood pressure <50 mmHg is considered hypotension
-
risk of bradycardia requiring interventions
Time frame: 1-3d after abdominal surgeries
heart rate <40/min is considered bradycardia
-
use of opioids and use of benzodiazepins
Time frame: 1-3d after abdominal surgeries
Sponsors and collaborators
Lead sponsor
Chinese Medical Association
Network
Registry information
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2016
- First posted
- Feb 2, 2016
- Registry last updated
- Feb 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.