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Comparison of Nalbuphine, Ondansetron and Placebo for Preventing Shivering After Spinal Anaesthesia in Urgency Caesarean Section: a randomized controlled clinical study

Comparison of Nalbuphine, Ondansetron and Placebo for Preventing Shivering After Spinal Anaesthesia in Caesarean Section: a randomized controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IND-17012488
Enrollment
Unknown
Registered
2017-08-27
Start date
2017-08-08
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Shiver

Interventions

C:iv 0.9%NS 4ml
O:iv ondansetron 8mg
N:iv nalbuphine 0.04mg/kg

Sponsors

Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University Shanghai
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) ASA grade I to II; (2) Aged 20-45 years old; (3) 150-180cm height; (4) 60-100kg weight; (5) Indices of cardiac, liver, kidney, blood and other examinations are in the normal range; (6) Full-term singleton pregnancies; (7) According to GCP, all volunteers sign the informed consent.

Exclusion criteria

Exclusion criteria: The exclusion criteria were as follows: contraindications to neuraxial anaesthesia, allergy to a study drug, body mass index (BMI) >35 kg m-2, pregnancy-induced hypertension, impaired renal or hepatic function, thyroid disease, neuromuscular disease, vasodilator use, body temperature >38 °C or <36.5 °C, prior labour analgesia and refusal to participate.

Design outcomes

Primary

MeasureTime frame
The incidence of post-anaesthesia maternal shivering before delivery;

Secondary

MeasureTime frame
The incidence and severity of maternal shivering after spinal anaesthesia;APGAR score;Haemodynamics;tympanic membrane temperature;Sedation scores;

Countries

China

Contacts

Public ContactShaoqiang Huang

Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University Shanghai

timrobbins@163.com13918210787

Outcome results

None listed

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