Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01221025
First received: October 12, 2010
Last updated: March 24, 2011
Last verified: October 2010
  Purpose

This prospective, double blind, placebo-controlled, parallel group study will be conducted in three study centers in Guangzhou, China. Patients aged older than 65 (ASA I-III) undergoing primary elective abdominal surgery with general anesthesia will be involved in this study. According to previous studies and our pilot trial, the sample size was estimated to be 900 subjects (each center recruiting 300 patients). All eligible patients will be randomly assigned to one of two groups: study group receiving parecoxib and control group receiving normal saline. All patients will be managed with by a standard clinical anesthesia protocol with a sevoflurane-based general anesthesia with continuous intravenous remifentanil, followed by a postoperative PCA with morphine. The emergence delirium will be evaluated by two persons blinding to medication and grouping using Riker sedation-agitation scale immediately since tracheal extubation and at specific time points until patients being discharged from PACU. Pain intensity assessments and pain relief assessments will also be conducted by the patients at given time points in 2 days postoperatively. The morphine-sparing effect, tolerability and safety of parecoxib will be investigated as well.


Condition Intervention Phase
Emergence Delirium
Postoperative Pain
Drug: Parecoxib
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Parecoxib on Emergence Delirium and Postoperative Pain in Elderly Patients Undergoing Abdominal Surgery After General Anesthesia

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • emergence agitation [ Time Frame: 45 min after anesthesia ] [ Designated as safety issue: No ]
    the incidence of emergence agitation after recovery from general anesthesia before discharging from PACU


Secondary Outcome Measures:
  • The amount of morphine consumption and Pain intensity [ Time Frame: 48h postoperatively ] [ Designated as safety issue: No ]
    The amount of morphine consumption from PCA pump at PACU, 12, 24, 36, and 48h after first dose of study medication; Pain intensity (NRS scores) at 2, 4, 6, 9, 12, 18, 24, 36 and 48 h after the first dose of study medication.


Estimated Enrollment: 900
Study Start Date: September 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: parecoxib
Parecoxib, a water-soluble prodrug of valdecoxib, is a high-selective COX-2 inhibitor that is first available for intravenous administration.
Drug: Parecoxib
The study group will receive first dose of intravenous (IV) injection of parecoxib sodium 40 mg (in a volume of 2 ml) 60 min before the anticipated end of surgery, followed 2 ml IV injection of parecoxib 40 mg will be occurred at 12, 24 and 36 h after the first dose of parecoxib.
Other Name: Brand name: Dynastat

Detailed Description:

The inclusion criteria of this study includes:

  • Aged older than 65;
  • Primary elective abdominal surgery under general anesthesia;
  • Ability to understand how to use pain assessment scales and PCA device.

The outcome measures of this study includes:

  • Emergence Delirium Assessment;
  • Pain intensity and pain relief efficacy endpoints;
  • Tolerability and Safety Assessments
  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged older than 65;
  • Body weight of at least 50 kg;
  • Primary elective abdominal surgery under general anesthesia;
  • Preoperative health graded as class ASA I-III, based on medical history and physical examination;
  • Ability to understand how to use pain assessment scales and PCA device

Exclusion Criteria:

  • Emergency or revised abdominal surgery;
  • History of known use of analgesics or any other agent that could interfere with analgesic responses during the up to 24 h before receipt of the study medication which including NSAIDs, tricyclic antidepressants, neuroleptic or antipsychotic agents, or corticosteroids (except routine preoperative medication);
  • History of known or suspected drug abuse;
  • Known allergy, sensitivity, or contraindication to opioid and non-opioid analgesic drugs;
  • History of bleeding disorders, peptic ulceration, or anticoagulant use within the past month;
  • History of asthma or bronchospasm;
  • History of inflammatory bowel disease, a chronic or acute renal or hepatic disorder, coronary heart disease;
  • History of dementia and psychological disorder;
  • Contraindication to parecoxib.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221025

Contacts
Contact: Haihua Shu, MD; Ph D +86-20-87755766 ext 8273 shuhaihua@gmail.com
Contact: Wenqi Huang, MD +86-20-87755766 ext 8273 huangwenqi86@yahoo.com.cn

Locations
China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Haihua Shu, MD; Ph D    +86-20-87755766 ext 8273    shuhaihua@gmail.com   
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Pfizer
Investigators
Principal Investigator: Haihua Shu, MD; Ph D First Affiliated Hospital, Sun Yat-Sen University
  More Information

Additional Information:
No publications provided

Responsible Party: Haihua Shu, The First Affliated Hospital of Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01221025     History of Changes
Other Study ID Numbers: SHHparecoxib1
Study First Received: October 12, 2010
Last Updated: March 24, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
Parecoxib;
emergence delirium;
postoperative pain;
elderly patients;
abdominal surgery
Parecoxib on emergence agitation and postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Delirium
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Parecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014