Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain
NCT01221025
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Adult Trials: 18+ Years
- 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
- 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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- Guangzhou, Guangdong
| 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:
The outcome measures of this study includes:
| |||
| 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 |
| |||
| 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 | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||