Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain

NCT01221025 | Unknown Phase 4 DMC

• 1 other identifier: SHHparecoxib1
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Delirium; Postoperative Pain

Keywords

Parecoxib;; emergence delirium;; postoperative pain;; elderly patients;; abdominal surgery; Parecoxib on emergence agitation and postoperative pain

Outcome Measures

Primary Outcomes (1)

• emergence agitation

  the incidence of emergence agitation after recovery from general anesthesia before discharging from PACU

  45 min after anesthesia

Secondary Outcomes (1)

• The amount of morphine consumption and Pain intensity

  48h postoperatively

Study Arms (1)

parecoxib

EXPERIMENTAL

Parecoxib, a water-soluble prodrug of valdecoxib, is a high-selective COX-2 inhibitor that is first available for intravenous administration.

Drug: Parecoxib

Interventions

Parecoxib DRUG

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.

Also known as: Brand name: Dynastat

parecoxib

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead
• Pfizer: collaborator

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative

Interventions

parecoxib

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain

Study Officials

• Haihua Shu, MD; Ph D

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haihua Shu, MD; Ph D

CONTACT

+86-20-87755766; shuhaihua@gmail.com

Wenqi Huang, MD

CONTACT

+86-20-87755766; huangwenqi86@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 14, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: March 25, 2011

Record last verified: 2010-10

Locations

CN (1)