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A randomised double blinded study comparing intrathecal bupivacaine with fentanyl versus bupivacaine with intravenous ondansetron on perioperative shivering in cesarean section

Effect of intrathecal bupivacaine plus fentanyl vs intrathecal bupivacaine plus intravenous Ondansetron on shivering in patients undergoing caesarean section under spinal anesthesia : A Randomised clinical study - NL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/098127
Enrollment
252
Registered
2025-11-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: 1- Obstetrics

Interventions

Intervention1: Intrathecal bupivacaine plus fentanyl: Patients receive spinal anesthesia with 2mL of 0.5% hyperbaric bupivacaine combined with intrathecal fentanyl (25 g). No intravenous ondansetron

Sponsors

Dr Rahul Hidangmayum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of American society of Anesthesiologist grade I or II, singleton pregnancy at term , elective caesarean section under spinal

Exclusion criteria

Exclusion criteria: Known hypersensitivity to ondansetron or fentanyl,History of motion sickness or use of anti-emetics within the past 24 hours,Patients with diabetes, hypertension, thyroid disorder, or any cardiovascular, respiratory, renal, hepatic, or neurological disease, conversion to general anesthesia,Infection at the spinal injection site,Preoperative abnormal body temperature or febrile patients,Spinal deformity,Bleeding disorder

Design outcomes

Primary

MeasureTime frame
Incidence and severity of shivering following spinal anesthesia assessed using a validated shivering scale for 45 minutesTimepoint: Incidence and severity of shivering following spinal anesthesia assessed using a validated shivering scale for every 5 minutes for 45 minutes

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Gojendra Rajkumar

Regional institute of medical sciences

gojendrar68@gmail.com9862824562

Outcome results

None listed

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