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NCT07902752Not yet recruitingPhase 2

Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs

A Prospective, Single-center, Randomized, Blinded Study to Evaluate the Efectiveness of Intranasal Oxytocin in Prevention of Opioid Induced Postoperative Sleep Apnea in Bariatric Surgery Patients

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

Drug overdose is a national crisis. The primary cause of death associated with opioids is opioid-induced respiratory depression. Naloxone (Narcan) which is the first line of defense for opioid overdose can reverse OIRD (Opioid-Induced Respiratory Depression), but in post-operative patients it will abolish pain control. There are no medications that can prevent OIRD. Pre-clinical studies provided evidence that intranasal (administered via a nasal spray) oxytocin may prevent and treat OIRD without interfering with pain control.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
100 (estimated)
First submitted
22 Oct 2026
Start date
15 May 2027
Primary completion date
14 Jul 2029
Lead sponsor
George Washington University
Diseases
Obesity
NCT number
NCT07902752

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 100
  • From 15 May 2027 to the primary completion date, 14 Jul 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • OSA patients on CPAP therapy
  • Chronic sinusitis requiring surgical treatment (except septal deviation)
  • Previous surgery for OSA (laser-assisted uvulopalatoplasty, LAUP or uvulopalatopharyngoplasty)

Other illness

  • Unstable cardiovascular disease (decompensated CHF, myocardial infarction or revascularization procedures, and unstable arrhythmias)
  • Uncontrolled hypertension (BP \> 190/110)
  • Chronic Obstructive Pulmonary Disease or another intrinsic lung disease
  • Renal failure on dialysis
  • Diabetes mellitus requiring insulin
  • Allergy to oxytocin

Other

  • Chronic opioid use (daily use of opioids)
  • Chronic muscle weakness
  • Chronic daytime hypoxemia (PaO2 \< 70) or hypercapnia (PaCO2 ≥ 45 mmHg)
  • Chronic supplemental oxygen use
  • Diabetic neuropathy
  • Hypoglossal nerve stimulator
  • Pregnancy
  • Premenopausal women, who are not on birth control

Who the study is looking for

  • ≥ 18 years of age
  • BMI ≥ 35 kg/m2
  • Scheduled or to be scheduled for bariatric surgery

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.