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Effect of Dexmedetomidine for Postoperative Intravenous Patient Controlled Analgesia

Primary Purpose

Patient-Controlled Analgesia

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dezocine
Flubiprofen
Dexmedetomidine
Sponsored by
Weifeng Tu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Patient-Controlled Analgesia focused on measuring Dexmedetomidine, Dezocine, Flubiprofen, Analgesia, Colorectal Surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Guangzhou General Hospital of Guangzhou Military CommandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Dexmedetomidine Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Dezocine consumption by patient-controlled analgesia
The total consumption of dezocine during 24 hours after surgery are recorded.
Change in pain score
Pain scores at rest and movement are evaluated with a numeric rating scale (NRS).

Secondary Outcome Measures

Change in ramsay sedation score
Measure sedation level by using ramsay sedation score
The incidence rates of postoperative nausea and vomiting (PONV)
Measure whether nausea and vomiting exist and the level of severity.

Full Information

First Posted
January 3, 2017
Last Updated
January 6, 2017
Sponsor
Weifeng Tu
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1. Study Identification

Unique Protocol Identification Number
NCT03014713
Brief Title
Effect of Dexmedetomidine for Postoperative Intravenous Patient Controlled Analgesia
Official Title
Effect of Dexmedetomidine Combined With Dezocine and Flubiprofen for Postoperative Intravenous Patient Controlled Analgesia After Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Weifeng Tu

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient-Controlled Analgesia
Keywords
Dexmedetomidine, Dezocine, Flubiprofen, Analgesia, Colorectal Surgery

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dexmedetomidine Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dezocine
Intervention Description
Dezocine 0.01mg/kg/h intravenous administration during the first two days after surgery.
Intervention Type
Drug
Intervention Name(s)
Flubiprofen
Intervention Description
Flubiprofen 0.5mg/kg/h intravenous administration during the first two days after surgery.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Dexmedetomidine 0.1μg/kg/h intravenous administration during the first two days after surgery.
Primary Outcome Measure Information:
Title
Dezocine consumption by patient-controlled analgesia
Description
The total consumption of dezocine during 24 hours after surgery are recorded.
Time Frame
At 24 hours after surgery
Title
Change in pain score
Description
Pain scores at rest and movement are evaluated with a numeric rating scale (NRS).
Time Frame
At 0, 2, 4, 8, 24, 48 and 72 hours after surgery
Secondary Outcome Measure Information:
Title
Change in ramsay sedation score
Description
Measure sedation level by using ramsay sedation score
Time Frame
At 0, 2, 4, 8, 24, 48 and 72 hours after surgery
Title
The incidence rates of postoperative nausea and vomiting (PONV)
Description
Measure whether nausea and vomiting exist and the level of severity.
Time Frame
At 24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists(ASA) Ⅰ-Ⅱ patient undergoing open colorectal surgery Written informed consent from the patient or the relatives of the participating patient. BMI:18~30kg/m2 Exclusion Criteria: Mental illness or cannot communicate.; A second operation during the study; Slow-type arrhythmias or hypotension; Lung infection or sleep apnea syndrome; Renal failure; Alcohol or drug abuse; Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug; Long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weifeng Tu, PhD
Phone
+8613922116606
Email
wftuyx02@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weifeng Tu, PhD
Organizational Affiliation
Guangzhou General Hospital of Guangzhou Military Command
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou General Hospital of Guangzhou Military Command
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weifeng Tu
Phone
+8613922116606
Email
wftuyx02@163.com
First Name & Middle Initial & Last Name & Degree
Chuangbo Xie
Phone
+8615521118558
Email
xiechuangbo@126.com
First Name & Middle Initial & Last Name & Degree
Weifeng Tu, PhD
First Name & Middle Initial & Last Name & Degree
Yang Zhou, PhD
First Name & Middle Initial & Last Name & Degree
Chuangbo Xie, Master

12. IPD Sharing Statement

Citations:
PubMed Identifier
26861737
Citation
Bellon M, Le Bot A, Michelet D, Hilly J, Maesani M, Brasher C, Dahmani S. Efficacy of Intraoperative Dexmedetomidine Compared with Placebo for Postoperative Pain Management: A Meta-Analysis of Published Studies. Pain Ther. 2016 Jun;5(1):63-80. doi: 10.1007/s40122-016-0045-2. Epub 2016 Feb 10.
Results Reference
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PubMed Identifier
26903197
Citation
Ge DJ, Qi B, Tang G, Li JY. Intraoperative Dexmedetomidine Promotes Postoperative Analgesia and Recovery in Patients after Abdominal Hysterectomy: a Double-Blind, Randomized Clinical Trial. Sci Rep. 2016 Feb 23;6:21514. doi: 10.1038/srep21514.
Results Reference
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PubMed Identifier
26889627
Citation
Jessen Lundorf L, Korvenius Nedergaard H, Moller AM. Perioperative dexmedetomidine for acute pain after abdominal surgery in adults. Cochrane Database Syst Rev. 2016 Feb 18;2(2):CD010358. doi: 10.1002/14651858.CD010358.pub2.
Results Reference
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Effect of Dexmedetomidine for Postoperative Intravenous Patient Controlled Analgesia

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