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The effect of opioid-free anesthesia combined with ultrasound-guided suprazygomatic maxillary nerve block on respiratory complications after tonsillectomy (or adenotonsillectomy) in children: A Randomized Controlled Trial

The effect of opioid-free anesthesia combined with ultrasound-guided suprazygomatic maxillary nerve block on respiratory complications after tonsillectomy (or adenotonsillectomy) in children: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095784
Enrollment
Unknown
Registered
2025-01-13
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Tonsil adenoid hypertrophy

Interventions

No opioid group:Prior to induction: dexmedetomidine hydrochloride nasal spray was injected into both sides of the patients nostrils at a dose of 2ug/kg. Simple intravenous induction: dexamethasone 0.1
Or combined induction: sevoflurane inhalation induction by tidal volume method, intravenous access was opened after the child's consciousness disappeared, and intravenous anesthesia was given. After i
Control group:Simple intravenous induction: dexamethasone 0.15mg/kg (Max. 4mg), propofol 2.5-3mg/kg, rocuronium 0.6mg/kg, fentanyl 1-2ug/kg, mask manual ventilation for 3-5min to the requirements of m

Sponsors

Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists (ASA) Class I-II pediatric patients; 2. Age 3-12 years old; 3. Tonsillar with (or with) adenoidectomy under general anesthesia; 4. Parents or guardians who can understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known cardiopulmonary diseases (untreated congenital heart disease, primary or secondary pulmonary hypertension, tumors, structural lung diseases); 2. Those with neuromuscular diseases; 3. Maxillofacial deformity; 4. BMI> = 95th percentile of people of the same age and sex; 5. Severe upper respiratory tract infection, and the chief anesthesiologist recommends postponing surgery; 6. Those who are allergic to the study drug; 7. Refusal of parents or guardians to participate in this study; 8. Those who have poor compliance and request to quit; 9. Unable to continue to participate in the trial due to objective factors during the follow-up process; 10. Those who underwent tonsillectomy with (without adenoid) resection for the second time.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative respiratory adverse events;

Secondary

MeasureTime frame
Recovery time;Duration of stay in anesthesia recovery room;Length of stay;Postoperative non-respiratory complications (including vomiting, bleeding, pharyngeal edema);Recovery delirium score (PAED for children recovering from anesthesia);Postoperative Pain Score (FLACC Scale);Number of PACU analgesic remedies and dosage of analgesic remedies;Heart rate;Pulse oxygen saturation;

Countries

China

Contacts

Public ContactZhang Yueying

The Affiliated Hospital of Xuzhou Medical University

zyy0218@126.com+86 180 5226 8602

Outcome results

None listed

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