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Effect of Dexmedetomidine for Postoperative Intravenous Patient Controlled Analgesia

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ClinicalTrials.gov Identifier: NCT03014713
Recruitment Status : Unknown
Verified January 2017 by Weifeng Tu, Guangzhou General Hospital of Guangzhou Military Command.
Recruitment status was:  Recruiting
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Weifeng Tu, Guangzhou General Hospital of Guangzhou Military Command

Brief Summary:
The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive analgesic, combined with dezocine and flubiprofen, used in intravenous Patient-Controlled Analgesia (PCA) after open colorectal surgery.

Condition or disease Intervention/treatment Phase
Patient-Controlled Analgesia Drug: Dezocine Drug: Flubiprofen Drug: Dexmedetomidine Phase 4

Detailed Description:

Dexmedetomidine is a selective alpha-2 adrenoceptor agonist, which has been demonstrated to have anaesthetic, sedative and analgesic-sparing effects. Besides, Dexmedetomidine has been reported to cause sedative effects and reduce opioid requirements in the perioperative period. Many studies had been conducted to reduce the side effect of opioid analgesic. The current trend of reducing opioid analgesic side effect is direct combination of other drugs in PCA. The advantages of this method are convenient in clinical use and preventive for side effects.

In this study, 50 patients who is undergoing elective colorectal surgery will be randomly allocated into two groups (Control group and Dexmedetomidine group). Patients in both groups will be given a patient-controlled analgesia (PCA) pump in post anesthetic recovery unit (PACU) after surgery.

The PCA protocol of Control group is dezocine 0.6mg/kg, flubiprofen 3mg/kg, diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min. The PCA protocol of Dexmedetomidine group is dezocine 0.6mg/kg, flubiprofen 3mg/k and dexmedetomidine 6μg/kg diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effect of Dexmedetomidine Combined With Dezocine and Flubiprofen for Postoperative Intravenous Patient Controlled Analgesia After Colorectal Surgery
Study Start Date : September 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Active Comparator: Control Group
Patients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h.
Drug: Dezocine
Dezocine 0.01mg/kg/h intravenous administration during the first two days after surgery.

Drug: Flubiprofen
Flubiprofen 0.5mg/kg/h intravenous administration during the first two days after surgery.

Experimental: Dexmedetomidine Group
Patients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h,dexmedetomidine 0.1μg/kg/h.
Drug: Dezocine
Dezocine 0.01mg/kg/h intravenous administration during the first two days after surgery.

Drug: Flubiprofen
Flubiprofen 0.5mg/kg/h intravenous administration during the first two days after surgery.

Drug: Dexmedetomidine
Dexmedetomidine 0.1μg/kg/h intravenous administration during the first two days after surgery.




Primary Outcome Measures :
  1. Dezocine consumption by patient-controlled analgesia [ Time Frame: At 24 hours after surgery ]
    The total consumption of dezocine during 24 hours after surgery are recorded.

  2. Change in pain score [ Time Frame: At 0, 2, 4, 8, 24, 48 and 72 hours after surgery ]
    Pain scores at rest and movement are evaluated with a numeric rating scale (NRS).


Secondary Outcome Measures :
  1. Change in ramsay sedation score [ Time Frame: At 0, 2, 4, 8, 24, 48 and 72 hours after surgery ]
    Measure sedation level by using ramsay sedation score

  2. The incidence rates of postoperative nausea and vomiting (PONV) [ Time Frame: At 24 hours after surgery ]
    Measure whether nausea and vomiting exist and the level of severity.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. American Society of Anesthesiologists(ASA) Ⅰ-Ⅱ patient undergoing open colorectal surgery
  2. Written informed consent from the patient or the relatives of the participating patient.
  3. BMI:18~30kg/m2

Exclusion Criteria:

  1. Mental illness or cannot communicate.;
  2. A second operation during the study;
  3. Slow-type arrhythmias or hypotension;
  4. Lung infection or sleep apnea syndrome;
  5. Renal failure;
  6. Alcohol or drug abuse;
  7. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug;
  8. Long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history;

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): NCT03014713


Contacts
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Contact: Weifeng Tu, PhD +8613922116606 wftuyx02@163.com

Locations
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China, Guangdong
Guangzhou General Hospital of Guangzhou Military Command Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Weifeng Tu    +8613922116606    wftuyx02@163.com   
Contact: Chuangbo Xie    +8615521118558    xiechuangbo@126.com   
Principal Investigator: Weifeng Tu, PhD         
Sub-Investigator: Yang Zhou, PhD         
Sub-Investigator: Chuangbo Xie, Master         
Sponsors and Collaborators
Weifeng Tu
Investigators
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Principal Investigator: Weifeng Tu, PhD Guangzhou General Hospital of Guangzhou Military Command
Publications:
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Responsible Party: Weifeng Tu, Chief Physician, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT03014713    
Other Study ID Numbers: Dexmedetomidine PCA
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Keywords provided by Weifeng Tu, Guangzhou General Hospital of Guangzhou Military Command:
Dexmedetomidine
Dezocine
Flubiprofen
Analgesia
Colorectal Surgery
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Flurbiprofen
Dexmedetomidine
Dezocine
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