Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain
Recruitment status was Recruiting
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.
|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|
- 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
- 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.
|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)|
Parecoxib, a water-soluble prodrug of valdecoxib, is a high-selective COX-2 inhibitor that is first available for intravenous administration.
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221025
|Contact: Haihua Shu, MD; Ph D||+86-20-87755766 ext firstname.lastname@example.org|
|Contact: Wenqi Huang, MD||+86-20-87755766 ext email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Haihua Shu, MD; Ph D||First Affiliated Hospital, Sun Yat-Sen University|