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A clinical trial to study the effects of two drugs, ondansetron versus hyoscine in patients undergoing cesarean section under spinal anaesthesia.

"A COMPARATIVE STUDY ON THE HEMODYNAMIC EFFECTS OF HYOSCINE VERSUS ONDANSETRON IN PATIENTS UNDERGOING CESAREAN SECTION UNDER SPINAL ANAESTHESIA" - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057985
Enrollment
170
Registered
2023-09-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Hyoscine: Intravenous administration of 1 ml of Hyoscine Butylbromide which contains 20 mg diluted to 2 ml, one minute after spinal anaesthesia. Control Intervention1: Ondansetron: Intr

Sponsors

Dr Anwesha Bayan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age group: 18 to 35 years 2. ASA physical status 2. 3. Normal singleton pregnancy with a gestational period of minimum 32 weeks. 4. Elective caesarean section under spinal anaesthesia. 5. Informed and written consent will be taken.

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA: 1. Allergy to study drugs. 2. Patient with known coagulopathy or patients on anticoagulation therapy. 3. Patient’s height 180 cm. 4. Patient with pregnancy induced hypertension 5. Patient with gestational diabetes mellitus 6. Patient with fetal distress 7. Patient with cardiac disease 8. Patient with Kidney disease 9. Patient with morbid obesity 10. BMI >35 kg per metre square 11. baseline bradycardia (HR- 60 bpm) or tachycardia (HR more than or equal to 100 bpm)

Design outcomes

Primary

MeasureTime frame
To compare the incidence of intraoperative bradycardia between the two groups.Timepoint: To compare the incidence of intraoperative bradycardia between the two groups at 0, 1, 3, 6, 9, 15, 20, 30, 40, 50 minutes.

Secondary

MeasureTime frame
To compare fetal APGAR score between the two groups.Timepoint: At 1 minute & 5 minutes.;To compare the changes in intraoperative hemodynamics between the two groups.Timepoint: Intraoperatively.;To compare the incidence of intraoperative nausea & vomiting between the two groups.Timepoint: Intraoperatively.;To compare the incidence of post operative nausea & vomiting between the two groups.Timepoint: 2 hours.

Countries

India

Contacts

Public ContactDr Anwesha Bayan

Gauhati Medical College and Hospital

trinasen8@gmail.com9707642773

Outcome results

None listed

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