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Effect of Nalbuphine on emergence agitation in children undergoing cochlear implantation

Effect of Nalbuphine on emergence agitation in children undergoing cochlear implantation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040407
Enrollment
Unknown
Registered
2020-11-28
Start date
2020-11-30
Completion date
Unknown
Last updated
2023-01-16

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

Conditions

emergence agitation

Interventions

Group A:0.1mg/kg nalbuphine
Group B:0.15 mg/kg nalbuphine
Group C:0.2 mg/kg nalbuphine
Group D:0.9% saline

Sponsors

the First Affiliated Hospital of the Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 3 Years

Inclusion criteria

Inclusion criteria: 1. Aged 6 months to 3 years; 2. ASA grades I-II; 3. BW 5~15kg; 4. patients who intend to undergo cochlear implant surgery under general anesthesia; 5. Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: 1. premature infants; 2. there is a state of airway hyperreaction such as upper respiratory tract infection before operation; 3. previous hypoxic ischemic encephalopathy with obvious sequelae; 4. congenital cardiac dysplasia with cardiac function > grade 3; 5. serious genetic diseases; 6. there are dysfunction of other important organs such as heart, brain, liver and kidney and abnormal blood coagulation before operation; 7. those who participated in other clinical trials in the three months before they were selected.

Design outcomes

Primary

MeasureTime frame
Incidence of emergence agitation;

Secondary

MeasureTime frame
time duration from drug withdrawal to extubation;nsufficient analgesia;Postoperative sedation;Side effects;

Countries

China

Contacts

Public ContactZeng Yi

the First Affiliated Hospital of the Air Force Medical University

zengyi1014@163.com+86 13991267646

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026