Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
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|ClinicalTrials.gov Identifier: NCT03325972|
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : December 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Dexmedetomidine Other: Placebo Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomized, Double-blind, Placebo-controlled Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery|
|Actual Study Start Date :||September 14, 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: IV dexmedetomidine
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
Placebo Comparator: Placebo
Other: Placebo Saline
Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
- Morphine equivalents used during the first 48 hours after surgery [ Time Frame: 48 Hours ]Amount of morphine administered during the 48 hours following surgery
- Numeric Pain Rating Scale (NRS) scores during the first 48 hours [ Time Frame: 48 Hours ]The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
- Numeric Pain Rating Scale (NRS) scores at 6 weeks post surgery [ Time Frame: 6 Weeks ]The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325972
|Contact: Lola Franco||212 263 firstname.lastname@example.org|
|United States, New York|
|New York University School of Medicine||Recruiting|
|New York, New York, United States, 10016|
|Contact: Lola Franco 212-263-0531 Lola.Franco@nyumc.org|
|Principal Investigator: Lisa Doan, MD|
|Principal Investigator:||Lisa Doan, MD||New York University School of Medicine|