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Effects of nalbuphine injection at different time points on stress response and inflammatory factors in recovery period of general anesthesia in children with tonsillectomy

Effects of nalbuphine injection at different time points on stress response and inflammatory factors in recovery period of general anesthesia in children with tonsillectomy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060118
Enrollment
Unknown
Registered
2022-05-19
Start date
2022-05-13
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

obstructive sleep apnea hypopnea syndrome

Interventions

Group A:Before anesthesia induction, Nalbuphine hydrochloride injection 0.2mg/kg was injected intravenously, diluted to 5ml with sterile normal saline
Group B:Nalbuphine hydrochloride injection 0.2mg/kg was injected intravenously 10 minutes before the end of the operation, diluted to 5ml with sterile normal saline
Group C:None

Sponsors

The Children's Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of obstructive sleep apnea hypopnea syndrome (OSAHS), adenotonsillectomy is required; 2. Aged 4-12 years, gender is not limited, weight 10-40 Kg, BMI 14.0-28kg/m^2, ASA class I or II, surgery time 30-90 min; 3. The child's parent or legal guardian signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to nalbuphine hydrochloride or its components, children with a history of opioid allergy; 2. Analgesic sedatives, emetic drugs and antipruritus drugs were used 24 hours before surgery; 3. Patients with body temperature higher than 38? or symptoms of acute upper respiratory tract infection within 24h before surgery; 4. Renal function impairment (BUN and/or Cr> upper limit of normal); Liver function impairment (ALT and/or AST>1.5 times the upper limit of normal); 5. Patients with a history of severe head trauma and intracranial hypertension within 6 months; 6. Patients suffering from chronic neurological or mental diseases, or unable to express their wishes correctly; 7. Patients with a history of long-term sedative and analgesic drugs or monoamine oxidase inhibitors; 8. Accompanied by heart, blood, immune and other systemic diseases; 9. Patients with other conditions were not considered suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
steroids;inflammatory factors;blood glucose;

Secondary

MeasureTime frame
heart rate;blood pressure;FLACC Pain Score;Ramsay Sedation Score;

Countries

China

Contacts

Public ContactCao Hongmin

The Children's Hospital of Zhejiang University School of Medicine

6514070@zju.edu.cn+86 18867521743

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026