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A randomized controlled study of dexmedetomidine hydrochloride nasal spray for sedation during elective cesarean section : evaluation of maternal and infant safety and efficacy based on composite endpoints

A randomized controlled study of dexmedetomidine hydrochloride nasal spray for sedation during elective cesarean section : evaluation of maternal and infant safety and efficacy based on composite endpoints

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107767
Enrollment
Unknown
Registered
2025-08-18
Start date
2025-08-25
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

Sedation during cesarean section

Interventions

Dexmedetomidine group:Dexmedetomidine nasal spray ( 25 µg / spray × 4 spray, total 100 µg ) was injected immediately after umbilical cord clamping. Operation specification : maternal head back 45 °, b
Saline group:Nasal spray of the same amount of normal saline after umbilical cord amputation (appearance and operation procedure are consistent with the intervention group)

Sponsors

Panzhihua Hospital of Integrated Traditional Chinese and Western Medicine/ Affiliated Hospital of Panzhihua University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Singleton full-term ( >=37 weeks ) parturients undergoing elective cesarean section under spinal / epidural anesthesia ; 2.ASA grade I-II ; 3.18-40 years old, BMI 18-30 kg / m^2 ; 4.Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: 1.Emergency surgery : patients with severe pregnancy complications such as acute fetal distress, eclampsia, and placenta previa ; 2.Developmental abnormalities such as fetal congenital malformations ; 3.Diseases such as nasal structural abnormalities or recent history of nasal surgery ; 4.With bradycardia ( HR < 60 beats / min ), hypotension ( SBP < 90 mmHg ) or severe cardiopulmonary disease ; 5.Dexmedetomidine allergy history ; 6.History of mental illness ; 7.General anesthesia patients with spinal anesthesia contraindications.

Design outcomes

Primary

MeasureTime frame
Sedation scale;Oxygen saturation;Heart rate;Blood pressure;1-minute Apgar score;Whether endotracheal intubation is required;Neonatal Neurological Score;Sedative dosage;The first effective sucking time and the number of lactations within 24 hours;

Secondary

MeasureTime frame
Postpartum depression score ( EPDS scale );Shivering;The first postoperative exhaust time;Nausea and vomiting;

Countries

China

Contacts

Public ContactFeng Zhu

Panzhihua Hospital of Integrated Traditional Chinese and Western Medicine/ Affiliated Hospital of Panzhihua University

28261691@qq.com+86 139 8234 5569

Outcome results

None listed

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