Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery

NCT03325972 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 14-00915
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, prospective, double-blind , placebo-controlled trial examining the effects of intraoperative dexmedetomidine infusion on pain in patients undergoing lumbar spinal fusion surgery. One hundred ten subjects (55 in each arm) will be enrolled. Subjects, over the age of 18, undergoing lumbar spinal fusion will be considered eligible for enrollment. Subjects will receive either intraoperative dexmedetomidine or placebo of normal saline infusion. They will be followed for approximately six weeks postoperatively.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Morphine Equivalents Used During the First 48 Hours Post-Surgery

  Amount of morphine administered during the 48 hours following surgery.

  Up to 48 Hours Post-Surgery (Day 2)

Secondary Outcomes (11)

• Mean Numeric Pain Rating Scale (NRS) Scores During the First 48 Hours Post-Surgery

  48 Hours Post-Surgery (Day 2)

• Numeric Pain Rating Scale (NPRS) Score at 6 Weeks Post-Surgery

  Week 6

• Morphine Equivalents Used at 6 Weeks Post-Surgery

  Up to Week 6

• Number of Participants Requiring Pressor Use During Intraoperative Period

  From beginning up to end of surgery (Day 0 - typically 1 to 3 hours)

• Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery

  Up to 48 Hours Post-Surgery (Day 2)

Study Arms (2)

IV dexmedetomidine

EXPERIMENTAL

Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

saline placebo

Other: Placebo Saline

Interventions

Dexmedetomidine DRUG

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.

IV dexmedetomidine

Placebo Saline OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults who will undergo lumbar spinal fusion, including surgeries extending into thoracic and sacral segments
• Subject is non-lactating and is either:
• Not of childbearing potential
• Of childbearing potential but is not pregnant at time of surgery as determined by pre-surgical pregnancy testing
• Subject is ASA physical status 1, 2, or 3.

You may not qualify if:

• Subject is pregnant or breastfeeding
• Any subject whom the investigators deem unable to complete any/all research related tasks
• Subjects who are cognitively impaired (by history)
• Subject requires antipsychotic medications
• Subject has received treatment with alpha-2 agonists or antagonists within 2 weeks prior to surgery
• Subject has known allergy to dexmedetomidine
• Subjects with impaired renal or hepatic function
• Subjects with advanced heart block
• Subjects with severe ventricular dysfunction

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Lisa Doan, MD
• Organization: NYU Langone Health

Lisa.Doan@nyulangone.org

212.201.1004

Study Officials

• Lisa Doan, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: October 30, 2017
• Study Start: September 14, 2016
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: June 5, 2023
• Results First Posted: March 21, 2023

Record last verified: 2023-05

Locations

US (1)