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
Recruitment status was Recruiting
Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
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
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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
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:
|
Delirium Pain, Postoperative Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Postoperative Complications Pathologic Processes Pain 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 Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on June 18, 2013