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

NCT ID: NCT03325972

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-14
• Study Completion Date: 2022-02-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IV dexmedetomidine

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

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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.

Placebo

saline placebo

Group Type: PLACEBO_COMPARATOR

Placebo Saline

Intervention Type: 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.

Interventions

Dexmedetomidine

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Doan, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14-00915

Identifier Type: -

Identifier Source: org_study_id