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A clinical trial to study the effects of two drugs, Ondansetron and Naloxone in patients undergoing Caesarean section following Intrathecal Morphine

Prevention of Intrathecal Morphine-Induced Pruritus and Post-operative Nausea and Vomiting in patients undergoing Caesarean Section using Ondansetron Versus Naloxone-A comparative study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075303
Enrollment
100
Registered
2024-10-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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: INTRAVENOUS PHENIRAMINE MALEATE 22.75MG: IF patient still complaints of pruritus during post-operative period (within 24 hours),then Inj. Pheniramine maleate 22.75mg IV bolus is given.

Sponsors

Dr Aysha Beevi M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA Grade I & II 2.Elective Caesarean Section 3.Patient willing to participate in the study 4.Patient with no history of neurological diseases 5.Patient With no history of allergy to Opioids, antiemetics and local anaesthetics.

Exclusion criteria

Exclusion criteria: 1.Patient not willing to participate in the study 2.ASA Grade III & IV 3.Emergency Surgery (Hemodynamic Compromise) 4.Contraindication to Spinal Anaesthesia 5.Patient With history of allergy to Opioids, antiemetics and local anaesthetics. 6.Pre-existing Dermatological Condition causing Pruritus at time of surgery 7.History of Respiratory disease, Cardiac disease, Neurological disease, Psychiatry disorder, Bleeding diathesis. 8.History of substance abuse

Design outcomes

Primary

MeasureTime frame
To Compare the efficacy of prophylactic Intravenous Ondansetron and Subcutaneous Naloxone in prevention of Intrathecal Morphine Induced Pruritus and Post-Operative nausea and vomiting.Timepoint: 24 hours

Secondary

MeasureTime frame
To elicit the incidence of pruritus & post-operative nausea & vomiting following Intrathecal Morphine in patients undergoing Caesarean sectionTimepoint: 24 hours;To find out the variation with those who received prophylactic Intravenous Ondansetron & Subcutaneous Naloxone especially in terms of post-operative analgesia durationTimepoint: 24 hours

Countries

India

Contacts

Public ContactDr Aysha Beevi M

Director, Institute of Anaesthesiology, Madurai medical college

ranikalyanasundaram@gmail.com9842111311

Outcome results

None listed

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