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

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 Overview

• Status: Unknown
• Conditions: Postoperative Pain; Emergence Delirium
• Intervention / Treatment: Drug: Parecoxib

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

• Study Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
      • Contact: Haihua Shu, MD; Ph D; Phone Number: 8273 +86-20-87755766; Email: shuhaihua@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Brand name: Dynastat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
emergence agitation	the incidence of emergence agitation after recovery from general anesthesia before discharging from PACU	45 min after anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Collaborators: Pfizer
• Investigators: Principal Investigator: Haihua Shu, MD; Ph D, First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

Helpful Links

• The website of The First Affiliated Hospital of Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: October 12, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (Estimate): October 14, 2010

Study Record Updates

• Last Update Posted (Estimate): March 25, 2011
• Last Update Submitted That Met QC Criteria: March 24, 2011
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: abdominal surgery; Parecoxib;; emergence delirium;; postoperative pain;; elderly patients;; Parecoxib on emergence agitation and postoperative pain
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pain, Postoperative; Delirium; Emergence Delirium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Parecoxib
• Other Study ID Numbers: SHHparecoxib1