A study to compare if giving the intervention Pethidine along with warming measures during Caesarean section surgery under spinal anesthesia, helps reduce shivering better versus warming alone among the participants

Efficacy of Pethidine along with intraoperative active warming in comparison with intraoperative active warming alone on incidence of shivering in caesarean section under spinal anaesthesia. A randomised controlled trial. - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/093981

Enrollment

280

Registered

2025-09-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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: Pethidine drug and intraoperative active warming: 0.5mg per kg IV of drug Pethidine will be given to intervention group after cord clamping and warm iv fluids and air warmer will be giv

Eligibility

Inclusion criteria

Inclusion criteria: ASA PS 2 Obstetric patients caesarean section under spinal anesthesia in JIPMER

Exclusion criteria

Exclusion criteria: 1) Parturients with grade 3,4 placenta previa, abruptio placenta. 2) Parturients with fever. 3) Parturients allergic to narcotics

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of Pethidine along with intraoperative active warming in comparison with intraoperative warming alone on the incidence of shivering among the women?s undergoing caesarean section under spinal anaesthesia.Timepoint: 2 years	—

Secondary

Measure	Time frame
To compare the core temperature in pethidine with intraoperative active warming group to only intraoperative active warming group.Timepoint: 2 years;To determine the influence of these interventions on maternal comfort temperature and general satisfaction.Timepoint: 2 years;To compare haemodynamic stability (blood pressure and heart rate) in the intervention group.Timepoint: 2 years;To establish the incidence of complications of Pethidine, including nausea, vomiting, headache or drowsiness.Timepoint: 2 years;To compare the requirement for rescue treatments for shivering among various study groups.Timepoint: 2 years	—

Measure

Time frame

To compare the core temperature in pethidine with intraoperative active warming group to only intraoperative active warming group.Timepoint: 2 years;To determine the influence of these interventions on maternal comfort temperature and general satisfaction.Timepoint: 2 years;To compare haemodynamic stability (blood pressure and heart rate) in the intervention group.Timepoint: 2 years;To establish the incidence of complications of Pethidine, including nausea, vomiting, headache or drowsiness.Timepoint: 2 years;To compare the requirement for rescue treatments for shivering among various study groups.Timepoint: 2 years

—

Countries

India

Contacts

Public ContactDr Ranjithkumar M

Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)

ranjithkumar.kmc@gmail.com8098030898

Outcome results

None listed

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