Skip to content

Evaluation of the efficacy and safety of dexmedetomidine nasal spray as an adjunct treatment for chronic radicular low back pain in elderly patients: A prospective randomized controlled trial

Evaluation of the efficacy and safety of dexmedetomidine nasal spray as an adjunct treatment for chronic radicular low back pain in elderly patients: A prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118648
Enrollment
Unknown
Registered
2026-02-09
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic radicular low back pain in the elderly

Interventions

DEX Group:During the first treatment, 30 minutes before pain treatment, intranasal dexmedetomidine was administered (one spray per nostril, 25 µg per spray) and intravenous placebo (2 ml of 0.9% salin
during the second treatment, 30 minutes before pain treatment, intranasal placebo (one spray per nostril of 0.9% saline) and intravenous midazolam (0.05 mg/kg) were administered. In this study's cross
MID group:During the first treatment, 30 minutes before pain treatment, a nasal spray placebo (1 spray in each nostril of 0.9% saline) was administered and intravenous midazolam (0.05 mg/kg) was given
during the second treatment, 30 minutes before pain treatment, a nasal spray of dexmedetomidine (1 spray in each nostril, 25 µg per spray) was administered and an intravenous placebo (2 ml of 0.9% sal

Sponsors

Beijing Jishuitan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 60 years; 2.Within 30 days, it is planned to perform the same invasive pain treatment procedure two times or more, including lumbar nerve root block and lumbar nerve root radiofrequency ablation. 3.At the time of the consultation, the pain intensity was>=4 on the Visual Analog Scale (VAS). 4.The subjects signed informed consent forms.

Exclusion criteria

Exclusion criteria: 1.Patients with known allergy or intolerance to dexmedetomidine or midazolam. 2.Psychomotor agitation; 3.There is a documented risk of aspiration: bowel obstruction, vomiting, nausea, and clinically relevant gastroesophageal reflux. 4.Risk factors for respiratory distress include: recent (20 breaths/minute), and known sleep apnea without non-invasive ventilatory support. 5.Contraindications for nasal medications: Nasal trauma or obstruction: excessive mucus, bleeding, anatomical abnormalities, tumors, or foreign body obstruction. 6.Cardiac risk factors: Recent (<7 days) congestive heart failure, known life-threatening arrhythmias or conduction disorders, heart rate <60 beats/minute or second- or third-degree atrioventricular block without a pacemaker, systolic blood pressure <=100 mmHg, digitalis therapy. 7.The researchers determined that the participants were not suitable for the trial. 8.The patient participated in other studies concurrently, which seriously impacted this study.

Design outcomes

Primary

MeasureTime frame
Ramsay Sedation Score (RSS score);

Secondary

MeasureTime frame
Iowa Anesthesia Satisfaction Score;Incidence of adverse reactions;VAS score;Depression;Oswestry Disability Index (ODI);Anxiety;Cognitive function;Sleep disorders;RSS rating;Quality of life;

Countries

China

Contacts

Public ContactYan Zhou

Beijing Jishuitan Hospital, Capital Medical University

zhouyanstudy@sina.com+86 10 8355 9626

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026