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Effects of different doses of alfentanil administration in tonsillectomy and adenoidectomy of children: a randomized double-blind controlled trial.

Effects of different doses of alfentanil administration in tonsillectomy and adenoidectomy of children

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035029
Enrollment
Unknown
Registered
2020-07-28
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-08-03

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

Conditions

Tonsillar and adenoidal hypertrophy

Interventions

group A20 :Low-dose alfentanil
group A40:medium-dose alfentanil
group A60:high-dose Alfentanil

Sponsors

The Second Affiliated Hospital of Wenzhou Medical University/ Yuying Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Informed consent was signed by the family members of the subjects; 2. Subjects aged 4-7 years; 3. Subjects of ASA grade I-II; 4. Subjects with body weight greater than 14 kg but less than 26 kg; 5. Those who need tonsillectomy under general anesthesia; 6. Subjects with normal or abnormal laboratory and imaging results but no clinical significance.

Exclusion criteria

Exclusion criteria: 1. Patients with allergic history of general anesthesia drugs; 2. Patients who have taken analgesics, sedatives or other psychoactive drugs in the past two weeks; 3. Patients with history of upper respiratory tract infection in recent 6 weeks; 4. Patients with history of reactive airway diseases; 5. Patients with suspected difficult airway; 6. Patients with neuromuscular diseases; 7. Patients with impaired liver and kidney function; 8. Patients with metabolic diseases; 9. Patients who have participated in other drug trials within 3 months; 10. Patients who are considered ineligible for any reason by the researchers.

Design outcomes

Primary

MeasureTime frame
Helbo-Hansen Score;

Secondary

MeasureTime frame
Heart rate;Blood pressure;Pulse oxygen saturation;MAC;Spontaneous breathing recovery time;Extubation time;Eye open time;Total observation time of PACU;VAS score;Ramsay sedation score;Agitation score;

Countries

China

Contacts

Public ContactWangning Shangguan

The Second Affiliated Hospital of Wenzhou Medical University/ Yuying children's Hospital

sgwning@163.com+86 13587637891

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026