Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01221025
• Other study ID #: SHHparecoxib1
• Status: Recruiting
• Phase: Phase 4
• First received: October 12, 2010
• Last updated: March 24, 2011
• Start date: September 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2010
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Haihua Shu, MD; Ph D
• Phone: +86-20-87755766
• Email: shuhaihua[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Pain, Postoperative
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University	Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	emergence agitation	the incidence of emergence agitation after recovery from general anesthesia before discharging from PACU	45 min after anesthesia	No
Secondary	The amount of morphine consumption and Pain intensity	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.	48h postoperatively	No

External Links

•   The website of Pfizer Global Investigator Initiated Research
•   The website of The First Affiliated Hospital of Sun Yat-sen University