Intraoperative Sedatives and Postoperative Pain

Arthritis, Degenerative Clinical Trial

Official title:

The Influence of Intraoperative Sedative on Postoperative Pain in Total Knee Arthroplasty Under Spinal Anesthesia: Comparison Between Dexmedetomidine and Propofol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784626
• Other study ID #: B-1603/339-005
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2016
• Last updated: October 25, 2016
• Start date: May 2016
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Seoul National University Bundang Hospital Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In this study, based on the hypothesis that dexmedetomidine administered intraoperatively for sedation can reduce postoperative pain than that of propofol, the investigators examined the ability of dexmedetomidine to reduce postoperative pain in in patients undergoing the total knee arthroplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing total knee arthroplasty

• Age: 20 - 80 yrs

Exclusion Criteria:

• ASA classification = 3

• Patient who do not want sedation during the surgery

• Patient who wants general anesthesia

• Cardiovascular disease

• Liver dysfunction

• Renal dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthritis, Degenerative
• Osteoarthritis
• Pain, Postoperative

Intervention

Drug:
• Dexmedetomidine
Intraoperative sedation using dexmedetomidine
• Propofol
Intraoperative sedation using propofol

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nausea and vomiting	Incidence of nausea and vomiting during 24 hours postoperatively	Postoperative 24 hours	No
Other	Nausea and vomiting	Incidence of nausea and vomiting during 48 hours postoperatively	Postoperative 48 hours	No
Other	Antiemetics	Amount of antiemetics administered during 24 hours postoperatively	Postoperative 24 hours	No
Other	Antiemetics	Amount of antiemetics administered during 48 hours postoperatively	Postoperative 48 hours	No
Other	Patient's satisfaction	Patient's satisfaction with the pain management using a visual analogue scale (0 = very unsatisfied, 10 = completely satisfied)	Postoperative 48 hours	No
Primary	Visual analogue scale	Postoperative pain score at postoperative 24 hours	Postoperative 24 hours	No
Secondary	Rescue analgesics	Amount of rescue analgesics administered during 24 hours postoperatively	Postoperative 24 hours	No
Secondary	Rescue analgesics	Amount of rescue analgesics administered during 48 hours postoperatively	Postoperative 48 hours	No
Secondary	Visual analogue scale	Postoperative pain score at postoperative 48 hours	Postoperative 48 hours	No