Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery

Pain Clinical Trial

Official title:

A Double-Masked Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973452
• Other study ID #: 13-163
• Status: Completed
• Phase: Phase 3
• Start date: October 2013
• Est. completion date: December 22, 2022

Study information

• Verified date: December 2022
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see if the drug, Dexmedetomidine (also known as Precedex), can reduce pain for patients having Thoracic Surgery and therefore reduce the amount of opioid drug needed after surgery. It is a drug that is already approved by the FDA (Food & Drug Administration) for use as a sedative in hospitals and is currently used in the investigators Intensive Care Unit for this purpose. The investigators want to investigate if it also has pain relieving properties.

Description:

The study involves the use of dexmedetomidine infusion intraoperatively during thoracic surgical procedures (not using an epidural) with discontinuation in the immediate postoperative period. A key feature in this study is to employ the drug infusion intraoperatively only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Adult patients ( = 21 years old) scheduled for Thoracic Surgery

Exclusion Criteria:

• 2nd or 3rd degree heart block as assessed by preoperative EKG

• Use of dexmedetomidine within 28 days prior to day of surgery

• Use of long acting opioids pre-operatively 28 days prior to day of surgery

• Current or past diagnosis of a Major Psychiatric disorder precluding adequate outcome responses such as Schizophrenia, dementia, delirium etc. as recorded in the Pre-Operative Record.

• Documentation of congestive heart failure and Ejection fraction < 30% if recorded in the Pre-Operative Record.

• Planned use of an epidural for surgery or post-operative pain relief

• Contraindication to use of NSAID, Acetaminophen or IV opioids.

• Any known hypersensitivity to dexmedetomidine

• Pregnant or breastfeeding

• Abnormal liver function tests as related to the MSK guidelines for use of IV Acetaminophen

Yes or NO?; Is ALT greater than 2 x Upper Limit of Normal (> 75 U/L)?

• Abnormal renal function tests as related to contraindications to use of IV Ketorolac

Yes or No?; Is Serum Creatinine < 1.5 mg/dl?

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Dexmedetomidine

• Placebo

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center at Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Suffolk	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Cancer Center 1275 York Avenue	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Opioid Administered	total opioid equivalents used postoperatively as measured by the total opioid administered in approximately the first 4 hours	up to 4 hours
Secondary	Improves Analgesia	as measured by change in Pain Numerical Rating Scale (NRS) preoperatively to postoperatively at rest and with activity (such as coughing). In the Pain Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'	up to 24 hours
Secondary	Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation	as measured by incidence of recorded nausea or the use of antiemetics and RASS sedation scores, respectively.	up to 24 hours

External Links

•   Memorial Sloan Kettering Cancer Center