Effect of Dexmedetomidine for Postoperative Intravenous Patient Controlled Analgesia

Patient-Controlled Analgesia Clinical Trial

Official title:

Effect of Dexmedetomidine Combined With Dezocine and Flubiprofen for Postoperative Intravenous Patient Controlled Analgesia After Colorectal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03014713
• Other study ID #: Dexmedetomidine PCA
• Status: Recruiting
• Phase: Phase 4
• First received: January 3, 2017
• Last updated: January 6, 2017
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: Weifeng Tu, PhD
• Phone: +8613922116606
• Email: wftuyx02[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. American Society of Anesthesiologists(ASA) ?-? 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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Patient-Controlled Analgesia

Intervention

Drug:
• Dezocine
Dezocine 0.01mg/kg/h intravenous administration during the first two days after surgery.
• Flubiprofen
Flubiprofen 0.5mg/kg/h intravenous administration during the first two days after surgery.
• Dexmedetomidine
Dexmedetomidine 0.1µg/kg/h intravenous administration during the first two days after surgery.

Locations

Country	Name	City	State
China	Guangzhou General Hospital of Guangzhou Military Command	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Weifeng Tu

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View Citation

Jessen Lundorf L, Korvenius Nedergaard H, Møller AM. Perioperative dexmedetomidine for acute pain after abdominal surgery in adults. Cochrane Database Syst Rev. 2016 Feb 18;2:CD010358. doi: 10.1002/14651858.CD010358.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dezocine consumption by patient-controlled analgesia	The total consumption of dezocine during 24 hours after surgery are recorded.	At 24 hours after surgery	Yes
Primary	Change in pain score	Pain scores at rest and movement are evaluated with a numeric rating scale (NRS).	At 0, 2, 4, 8, 24, 48 and 72 hours after surgery	No
Secondary	Change in ramsay sedation score	Measure sedation level by using ramsay sedation score	At 0, 2, 4, 8, 24, 48 and 72 hours after surgery	No
Secondary	The incidence rates of postoperative nausea and vomiting (PONV)	Measure whether nausea and vomiting exist and the level of severity.	At 24 hours after surgery	No