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Evaluation of the Effect of Appropriate Sedation for Patients After Abdominal Surgeries : A Prospective Randomised Controlled Study

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ClinicalTrials.gov Identifier: NCT02670954
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Juanhong Shen, Chinese Medical Association

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Postoperative Sedation, Abdominal Surgery Drug: Dexmedetomidine, tramadol and flurbiprofen Drug: tramadol and flurbiprofen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexmedetomidine,tramadol and flurbiprofen
Both routine analgesic and sedation(dexmedetomidine,tramadol and flurbiprofen) are applied for this group of patients.
Drug: Dexmedetomidine, tramadol and flurbiprofen
Active Comparator: Tramadol and flurbiprofen
Only routine analgesic(Tramadol and flurbiprofen) is applied for this group of patients.
Drug: tramadol and flurbiprofen



Primary Outcome Measures :
  1. 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

  2. recovery of gastrointestinal function [ Time Frame: from admission to 30 days after abdominal surgeries ]
    assessed by time to first defecation

  3. 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

  4. 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 Outcome Measures :
  1. 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

  2. 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

  3. risk of bradycardia requiring interventions [ Time Frame: 1-3d after abdominal surgeries ]
    heart rate <40/min is considered bradycardia

  4. use of opioids and use of benzodiazepins [ Time Frame: 1-3d after abdominal surgeries ]


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Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670954


Locations
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China, Jiangsu
Institute of General Surgery of Jinling Hospital
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Chinese Medical Association
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Responsible Party: Juanhong Shen, Director, PhD, Resident Physician, Principal Investigator, Chinese Medical Association
ClinicalTrials.gov Identifier: NCT02670954    
Other Study ID Numbers: Jinling37ICU
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: basic characteristics of participant,interventions, primary and secondary outcomes, main results
Additional relevant MeSH terms:
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Flurbiprofen
Dexmedetomidine
Tramadol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors