Effect of Dexmedetomidine for Postoperative Intravenous Patient Controlled Analgesia

NCT03014713 | Unknown Phase 4

• 1 other identifier: Dexmedetomidine PCA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient-Controlled Analgesia

Keywords

Dexmedetomidine; Dezocine; Flubiprofen; Analgesia; Colorectal Surgery

Outcome Measures

Primary Outcomes (2)

• Dezocine consumption by patient-controlled analgesia

  The total consumption of dezocine during 24 hours after surgery are recorded.

  At 24 hours after surgery

• 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

Secondary Outcomes (2)

• Change in ramsay sedation score

  At 0, 2, 4, 8, 24, 48 and 72 hours after surgery

• The incidence rates of postoperative nausea and vomiting (PONV)

  At 24 hours after surgery

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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; Drug: Flubiprofen

Dexmedetomidine Group

EXPERIMENTAL

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; Drug: Flubiprofen; Drug: Dexmedetomidine

Interventions

Dezocine DRUG

Dezocine 0.01mg/kg/h intravenous administration during the first two days after surgery.

Control Group; Dexmedetomidine Group

Flubiprofen DRUG

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

Control Group; Dexmedetomidine Group

Dexmedetomidine DRUG

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

Dexmedetomidine Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Weifeng Tu: lead

Study Sites (1)

Guangzhou General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, 510010, China

RECRUITING

Related 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. Epub 2016 Feb 10.

  PMID: 26861737 BACKGROUND

• 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.

  PMID: 26903197 BACKGROUND

• 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.

  PMID: 26889627 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

dezocine; Flurbiprofen; Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Weifeng Tu, PhD

  Guangzhou General Hospital of Guangzhou Military Command

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weifeng Tu, PhD

CONTACT

+8613922116606; wftuyx02@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 9, 2017
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 9, 2017

Record last verified: 2017-01

Locations

CN (1)