Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain

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NCT01221025

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Study Location
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
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Contact
+86-20-87755766
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Emergence Delirium, Postoperative Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Emergence Delirium, Postoperative PainEffect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain
NCT01221025
  1. Guangzhou, Guangdong
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain
Official Title  ICMJE Effects of Parecoxib on Emergence Delirium and Postoperative Pain in Elderly Patients Undergoing Abdominal Surgery After General Anesthesia
Brief Summary 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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Emergence Delirium
  • Postoperative Pain
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: parecoxib
Parecoxib, a water-soluble prodrug of valdecoxib, is a high-selective COX-2 inhibitor that is first available for intravenous administration.
Intervention: Drug: Parecoxib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 13, 2010)		900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2012
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years to 90 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01221025
Other Study ID Numbers  ICMJE SHHparecoxib1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Haihua Shu, The First Affliated Hospital of Sun Yat-sen University
Study Sponsor  ICMJE First Affiliated Hospital, Sun Yat-Sen University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Haihua Shu, MD; Ph DFirst Affiliated Hospital, Sun Yat-Sen University
PRS Account First Affiliated Hospital, Sun Yat-Sen University
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP