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Using remimazolam and sevoflurane together for children's adenoid surgery

Clinical application study of different doses of remimazolam combined with sevoflurane in pediatric adenoidectomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67586415
Enrollment
256
Registered
2025-04-01
Start date
2024-01-01
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

Anesthesia management in pediatric adenoidectomy using plasma radiofrequency ablation Surgery

Interventions

A single-center, prospective, randomized controlled study was conducted, selecting 256 children who underwent plasma radiofrequency adenoidectomy at Gaoming District People's Hospital in Foshan City f

Sponsors

Gaoming District People's Hospital in Foshan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. ASA physical status I-II 2. Age 3-12 years 3. No difficult airway, Mallampati grade I-II 4. No upper respiratory tract infection in the past month 5. No neurological, cardiopulmonary, hepatic, or renal systemic diseases 6. Routine blood tests, coagulation function, electrolytes, hepatic and renal function tests, chest X-rays, and electrocardiograms show no significant abnormalities 7. Children scheduled for pediatric plasma radiofrequency adenoidectomy 8. Informed consent from the patient's family

Exclusion criteria

Exclusion criteria: Certainly! Here's the paragraph transformed into a numbered list: 1. BMI = 25 kg/m² 2. Upper respiratory tract infection, cardiopulmonary insufficiency within one month 3. Perioperative allergies 4. Unpredicted difficult airway 5. Failed intubation on the first attempt 6. Severe complications in children, such as hemorrhagic shock, anaphylactic shock, cardiac arrest, etc. 7. Changes in surgical or anesthesia plans due to medical conditions 8. Withdrawal from the study at the request of the patient's family 9. Loss to follow-up of the subjects

Design outcomes

Primary

MeasureTime frame
1. Anesthesia effects: Anesthesia time, awakening time (the interval from cessation of inhalation anesthesia to eye-opening on verbal command), and PACU stay time measured using data collected from patient medical records at one time point 2. ED situation: Emergence delirium measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale, which includes five items: eye contact, purposeful movement, awareness of the surrounding environment, restlessness, and inconsolability after surgery 3. Postoperative pain intensity measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale every 10 minutes during the first 30 minutes in the PACU 4. Parental satisfaction was measured using self-reported data on a numerical rating scale (NRS, range 0-10) 24 hours after surgery 5. Adverse reactions included dizziness, hallucinations, restlessness, laryngospasm, nausea and vomiting, hypertension (an increase in mean arterial pressure of more than 30% above baseline), and tachycardia (heart rate >120 beats per minute) measured using data collected from case reports at one time point 6. Behavioral changes three days after surgery measured using the 27-item Post-Hospital Behavior Questionnaire (PHBQ) through telephone interviews on the third day after surgery

Secondary

MeasureTime frame
There are no secondary outcome measures.

Countries

China

Contacts

Public ContactMin Wang
wangminee@126.com+86 1818883097

Outcome results

None listed

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