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Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain

Primary Purpose

Emergence Delirium, Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Parecoxib
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emergence Delirium focused on measuring Parecoxib;, emergence delirium;, postoperative pain;, elderly patients;, abdominal surgery, Parecoxib on emergence agitation and postoperative pain

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

parecoxib

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 12, 2010
Last Updated
March 24, 2011
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01221025
Brief Title
Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain
Official Title
Effects of Parecoxib on Emergence Delirium and Postoperative Pain in Elderly Patients Undergoing Abdominal Surgery After General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium, Postoperative Pain
Keywords
Parecoxib;, emergence delirium;, postoperative pain;, elderly patients;, abdominal surgery, Parecoxib on emergence agitation and postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
parecoxib
Arm Type
Experimental
Arm Description
Parecoxib, a water-soluble prodrug of valdecoxib, is a high-selective COX-2 inhibitor that is first available for intravenous administration.
Intervention Type
Drug
Intervention Name(s)
Parecoxib
Other Intervention Name(s)
Brand name: Dynastat
Intervention Description
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.
Primary Outcome Measure Information:
Title
emergence agitation
Description
the incidence of emergence agitation after recovery from general anesthesia before discharging from PACU
Time Frame
45 min after anesthesia
Secondary Outcome Measure Information:
Title
The amount of morphine consumption and Pain intensity
Description
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.
Time Frame
48h postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haihua Shu, MD; Ph D
Phone
+86-20-87755766
Ext
8273
Email
shuhaihua@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wenqi Huang, MD
Phone
+86-20-87755766
Ext
8273
Email
huangwenqi86@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haihua Shu, MD; Ph D
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haihua Shu, MD; Ph D
Phone
+86-20-87755766
Ext
8273
Email
shuhaihua@gmail.com

12. IPD Sharing Statement

Links:
URL
http://www.gzsums.net/
Description
The website of The First Affiliated Hospital of Sun Yat-sen University

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Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain

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