NCT01221025

Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain

Effects of Parecoxib on Emergence Delirium and Postoperative Pain in Elderly Patients Undergoing Abdominal Surgery After General Anesthesia

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Emergence Delirium
• Postoperative Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-12-01
• Completion: 2012-06-01
• First posted: 2010-10-14
• Last updated: 2011-03-25

Locations

1 site across 1 country: China