A clinical trial to study the effectiveness of a drug Granisetron to prevent shivering, nausea and vomiting, which occurs after giving spinal anaesthesia in pregnant females undergoing cesarean section

Efficacy of Granisetron for prevention of Post-Spinal anaesthesia shivering, nausea and vomiting in parturients undergoing caesarean section

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/12/016756

Enrollment

Registered

2018-12-21

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: G978- Other intraoperative and postprocedural complications and disorders of nervous system

Interventions

Intervention1: Injection Granisetron 2mg Intravenous: Injection Granisetron 2mg (3mg/3ml) diluted with Normal Saline to make total volume of 10 ml Control Intervention1: Normal Saline 0.9%: 10 ml Nor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Parturients scheduled for elective caesarean delivery under spinal anaesthesia 2. Aged 20-45 years 3. Full term singleton pregnancy

Exclusion criteria

Exclusion criteria: 1. Parturient with contra-indications to regional anaesthesia 2. ASA Physical Status > II 3. Allergy to 5-HT3 Antagonists 4. Morbidly Obese 5. Placenta Previa 6. Use of vasodilators 7. Pre-operative body temperature >38 C or < 36.5 C

Design outcomes

Primary

Measure	Time frame
Shivering ScoreTimepoint: 5 minutes before study drug administration till 180 minutes after spinal block	—

Secondary

Measure	Time frame
1. Incidence of nausea and/or vomiting 2. Tympanic Membrane temperature 3. Neonatal APGAR Score at 1 and 5 min 4. Patient Satisfaction Score-24 hours after procedure 5. Haemodynamic parameters ( heart rate, Systolic and diastolic blood pressure, mean arterial pressure, SpO2) 6. Total dose of rescue drug required for shivering (pethidine) 7. Total dose of rescue anti-emetic required for nausea and vomiting (metoclopramide)Timepoint: 5 minutes before study drug administration till 90 minutes after spinal block	—

Measure

Time frame

1. Incidence of nausea and/or vomiting 2. Tympanic Membrane temperature 3. Neonatal APGAR Score at 1 and 5 min 4. Patient Satisfaction Score-24 hours after procedure 5. Haemodynamic parameters ( heart rate, Systolic and diastolic blood pressure, mean arterial pressure, SpO2) 6. Total dose of rescue drug required for shivering (pethidine) 7. Total dose of rescue anti-emetic required for nausea and vomiting (metoclopramide)Timepoint: 5 minutes before study drug administration till 90 minutes after spinal block

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Countries

India

Contacts

Public ContactAmardeep Singh

Maulana Azad Medical College, New Delhi

dr_dali@rediff.com9968604212

Outcome results

None listed

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