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Effect of intranasal dexmedetomidine on the night before surgery on hypotension following induction in elderly hypertensive patients: A prospective, double-blind, randomized controlled trial

Effect of intranasal dexmedetomidine on the night before surgery on hypotension following induction in elderly hypertensive patients: A prospective, double-blind, randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127266
Enrollment
Unknown
Registered
2026-06-28
Start date
2026-06-29
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Post-Induction Hypotension, PIH

Interventions

Saline Group:Administer an equal volume of normal saline nasal spray. After administration, maintain the original position for 1 to 2 minutes to promote absorption. If the patient does not fall asleep
Dexmedetomidine Group:Dexmedetomidine hydrochloride nasal spray was administered (45µg (0.45 ml) for weight <45 kg). For 45-75 kg, administer 60µg (0.60 ml). For more than 75 kg, administer 75µg (0.75

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Age >= 65 years; 2.Scheduled for non-cardiac surgery under general anesthesia; 3.Diagnosed with hypertension (Stage I-II) , take antihypertensive medication regularly for past three months; 4.ASA grades I-III; 5.Sign informed consent form;

Exclusion criteria

Exclusion criteria: 1. Arrhythmia contraindication: Preoperative resting heart rate 2 weeks) use of sedative-hypnotics, anxiolytics, antidepressants, antipsychotics, or long-term use of alpha2-adrenergic receptor agonists (e.g., clonidine); 9. Cognitive or communication impairment: Alzheimer's disease, severe mental illness, or severe visual/auditory/language impairment that prevents understanding of the informed consent form or cooperation with anxiety/sleep scale assessments; 10. Special endocrine and metabolic diseases: Pheochromocytoma, uncontrolled hyperthyroidism, or other conditions that may cause abnormal catecholamine secretion or significantly elevated basal metabolic rate; 11. Extreme body mass index (BMI): BMI >35 kg/m^2 or BMI <18.5 kg/m^2; 12. Participation in other studies: Participation in other clinical trials within 30 days before enrollment; 13. Other conditions deemed ineligible by the investigators.

Design outcomes

Primary

MeasureTime frame
Post-Induction Hypotension;

Secondary

MeasureTime frame
Sleep Quality the Night Before Surgery;Total dose of vasoactive drugs administered during induction of anesthesia;Incidence of delirium after surgery;The incidence of hypoxemia;Incidence of arrhythmia;The incidence of nasal mucous membrane damage;Anxiety score;Wake-up time;Incidence of severe hypotension;Levels of plasma epinephrine, norepinephrine, and cortisol;Hemodynamic status during the induction period;Incidence of respiratory depression;Incidence of adverse events;

Countries

China

Contacts

Public ContactLiu Su

The Affiliated Hospital of Xuzhou Medical University

150040009@gmail.com+86 516 85805911

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026