Comparison of the anesthetic efficacy and recovery quality of remimazolam besylate versus sevoflurane for pediatric circumcision: a single-center, prospective, assessor-blinded, randomized controlled study protocol.
Saved in:
| Title: | Comparison of the anesthetic efficacy and recovery quality of remimazolam besylate versus sevoflurane for pediatric circumcision: a single-center, prospective, assessor-blinded, randomized controlled study protocol. |
|---|---|
| Authors: | Zhang Y; Department of Anesthesiology, Maternal and Child Health Hospital of Wanzhou District, Chongqing City, People's Republic of China., Guo S; Department of Anesthesiology, Maternal and Child Health Hospital of Wanzhou District, Chongqing City, People's Republic of China., Wang L; Nursing Department, Maternal and Child Health Hospital of Wanzhou District, Chongqing City, People's Republic of China., Zeng Q; Department of Anesthesiology, Maternal and Child Health Hospital of Wanzhou District, Chongqing City, People's Republic of China., Cui H; Department of Anesthesiology, Maternal and Child Health Hospital of Wanzhou District, Chongqing City, People's Republic of China., Mo Y; Department of Pediatrics, Maternal and Child Health Hospital of Wanzhou District, Chongqing City, People's Republic of China. moyunbo666@outlook.com. |
| Source: | BMC anesthesiology [BMC Anesthesiol] 2025 Oct 28; Vol. 25 (1), pp. 527. Date of Electronic Publication: 2025 Oct 28. |
| Publication Type: | Journal Article; Clinical Trial Protocol |
| Language: | English |
| Journal Info: | Publisher: BioMed Central Country of Publication: England NLM ID: 100968535 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2253 (Electronic) Linking ISSN: 14712253 NLM ISO Abbreviation: BMC Anesthesiol Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BioMed Central, 2001- |
| MeSH Terms: | Sevoflurane*/administration & dosage , Sevoflurane*/adverse effects , Circumcision, Male*/methods , Anesthetics, Inhalation*/administration & dosage , Anesthetics, Inhalation*/adverse effects , Benzodiazepines*/administration & dosage , Benzodiazepines*/adverse effects , Anesthesia Recovery Period*, Humans ; Male ; Child, Preschool ; Child ; Prospective Studies ; Randomized Controlled Trials as Topic ; Single-Blind Method ; Anesthesia, General/methods |
| Abstract: | Background: Administering anesthesia for circumcision in children involves prioritizing safety, comfort, and quality of recovery. While the effectiveness of remimazolam besylate in pediatric anesthesia requires additional confirmation, sevoflurane has been linked to complications like agitation and delirium upon recovery. This protocol describes a planned assessor-blinded randomized controlled trial to evaluate the anesthetic impacts, recovery features, and safety profiles of remimazolam compared to sevoflurane in children between the ages of 3 and 12 undergoing circumcision. Methods: This single-center, prospective, assessor-blinded, randomized controlled trial will be conducted at the Wanzhou District Maternal and Child Health Hospital. One hundred children (aged 3-12 years, ASA I-II) scheduled for painless circumcision will be randomly allocated to receive either intravenous remimazolam besylate (Group R, n = 50) or inhaled sevoflurane (Group S, n = 50) for general anesthesia. Both groups will receive a penile root block with 1% lidocaine. Primary outcomes include time to achieve general anesthesia (MOAA/S ≤ 1) and emergence time. Secondary outcomes include anesthesia success rate, intraoperative interventions, hemodynamic changes, respiratory complications, emergence delirium (PAED scale), pain scores (FLACC), and guardian anxiety levels. Due to inherent differences in drug delivery methods, only outcome assessors and data analysts will be blinded. Exploratory subgroup analyses by age (3-6 vs. 7-12 years) will be conducted but are not powered for definitive conclusions. Statistical analysis will use SPSS version 26.0 with significance at P < 0.05. Ethics and Dissemination: The Reproductive Ethics Committee at the Wanzhou District Maternal and Child Health Hospital has approved this protocol (Reference No. 2024-44). Consent from the legal guardians will be secured. Findings will be shared via publications in journals and presentations at academic conferences. Trial Registration: This trial has been registered with the Chinese Clinical Trial Registry (ChiCTR) (Registration number: ChiCTR2500095974; Registration date: January 15, 2025). (© 2025. The Author(s).) |
| References: | Eur J Clin Pharmacol. 2020 Mar;76(3):383-391. (PMID: 31873765) Paediatr Anaesth. 2011 Sep;21(9):942-50. (PMID: 21726352) Curr Opin Anaesthesiol. 2020 Aug;33(4):506-511. (PMID: 32530890) J Clin Psychopharmacol. 1990 Aug;10(4):244-51. (PMID: 2286697) Anesth Analg. 2007 Jan;104(1):84-91. (PMID: 17179249) Drugs. 2021 Jul;81(10):1193-1201. (PMID: 34196946) Front Med (Lausanne). 2021 Jul 27;8:641866. (PMID: 34386505) Pediatrics. 2012 Sep;130(3):e756-85. (PMID: 22926175) Curr Opin Anaesthesiol. 2014 Jun;27(3):309-15. (PMID: 24784918) J Anesth. 2022 Feb;36(1):1-4. (PMID: 34091736) J Anesth. 2020 Aug;34(4):543-553. (PMID: 32417976) Drugs. 2020 Apr;80(6):625-633. (PMID: 32274703) Anesthesiology. 1999 Sep;91(3):693-700. (PMID: 10485781) Anesth Analg. 2012 Aug;115(2):284-96. (PMID: 22253270) Am J Transl Res. 2020 Aug 15;12(8):4594-4603. (PMID: 32913533) Anesthesiology. 2004 May;100(5):1138-45. (PMID: 15114210) Pediatr Nurs. 1997 May-Jun;23(3):293-7. (PMID: 9220806) PLoS Med. 2025 Apr 14;22(4):e1004587. (PMID: 40228477) Pediatrics. 2006 Sep;118(3):1087-96. (PMID: 16951002) JAMA. 2025 Jan 7;333(1):71-74. (PMID: 39425955) PLoS Med. 2025 Apr 28;22(4):e1004589. (PMID: 40294521) |
| Grant Information: | wzwjw-kw2024031 The Joint General Fund for Science, Health Science, and Technology in Wanzhou District, Chongqing, People's Republic of China |
| Contributed Indexing: | Keywords: Anesthetic effect; Assessor-Blinded trial; Circumcision; Pediatric anesthesia; Recovery quality; Remimazolam besylate; Sevoflurane; Stratified randomization; Study protocol |
| Substance Nomenclature: | 38LVP0K73A (Sevoflurane) 0 (Anesthetics, Inhalation) 7V4A8U16MB (remimazolam) 12794-10-4 (Benzodiazepines) |
| Entry Date(s): | Date Created: 20251029 Date Completed: 20251029 Latest Revision: 20251203 |
| Update Code: | 20251204 |
| PubMed Central ID: | PMC12570819 |
| DOI: | 10.1186/s12871-025-03378-3 |
| PMID: | 41152767 |
| Database: | MEDLINE |
Full Text 
Full Text Finder 
Nájsť tento článok vo Web of Science | Abstract: | Background: Administering anesthesia for circumcision in children involves prioritizing safety, comfort, and quality of recovery. While the effectiveness of remimazolam besylate in pediatric anesthesia requires additional confirmation, sevoflurane has been linked to complications like agitation and delirium upon recovery. This protocol describes a planned assessor-blinded randomized controlled trial to evaluate the anesthetic impacts, recovery features, and safety profiles of remimazolam compared to sevoflurane in children between the ages of 3 and 12 undergoing circumcision.<br />Methods: This single-center, prospective, assessor-blinded, randomized controlled trial will be conducted at the Wanzhou District Maternal and Child Health Hospital. One hundred children (aged 3-12 years, ASA I-II) scheduled for painless circumcision will be randomly allocated to receive either intravenous remimazolam besylate (Group R, n = 50) or inhaled sevoflurane (Group S, n = 50) for general anesthesia. Both groups will receive a penile root block with 1% lidocaine. Primary outcomes include time to achieve general anesthesia (MOAA/S ≤ 1) and emergence time. Secondary outcomes include anesthesia success rate, intraoperative interventions, hemodynamic changes, respiratory complications, emergence delirium (PAED scale), pain scores (FLACC), and guardian anxiety levels. Due to inherent differences in drug delivery methods, only outcome assessors and data analysts will be blinded. Exploratory subgroup analyses by age (3-6 vs. 7-12 years) will be conducted but are not powered for definitive conclusions. Statistical analysis will use SPSS version 26.0 with significance at P < 0.05.<br />Ethics and Dissemination: The Reproductive Ethics Committee at the Wanzhou District Maternal and Child Health Hospital has approved this protocol (Reference No. 2024-44). Consent from the legal guardians will be secured. Findings will be shared via publications in journals and presentations at academic conferences.<br />Trial Registration: This trial has been registered with the Chinese Clinical Trial Registry (ChiCTR) (Registration number: ChiCTR2500095974; Registration date: January 15, 2025).<br /> (© 2025. The Author(s).) |
|---|---|
| ISSN: | 1471-2253 |
| DOI: | 10.1186/s12871-025-03378-3 |