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Shivering and changes in body temperature in patients undergoing operation for delivery of baby(cesarean section) under spinal anesthesia with a drug bupivacaine(local anesthetics)vs bupivacaine and fentanyl(opioid pain killer).

Shivering and changes in body temperature in patients undergoing cesarean section under spinal anesthesia with bupivacaine vs bupivacaine and fentanyl: a randomized clinical study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/013608
Enrollment
150
Registered
2018-05-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Pregnant women above 18 years of age of physical status ASA I and II scheduled for cesarean delivery under spinal anesthesia.

Interventions

Intervention1: Bupivacaine and fentanyl: Patients administered intrathecal bupivacaine (Hyperbaric) 0.5% 1.8ml with 12.5 micrograms fentanyl. Control Intervention1: Only bupivacaine: Patients administ

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women above 18 years of age of physical status ASA I & II scheduled for cesarean delivery under spinal anesthesia.

Exclusion criteria

Exclusion criteria: 1.Patients presenting with fever or shivering. 2.Placenta Previa and APH. 3.Obstetric or maternal condition and co-morbidities which may require spinal drug administration different from the study protocol (e.g. short stature, expected longer duration of surgery due to uterine abnormalities, hypertensive disorder of pregnancy, etc.) 4.Known allergy to drugs being used. 5.Patientâ??s refusal for spinal anesthesia.

Design outcomes

Primary

MeasureTime frame
To observe the number of patients who developed shivering and the grade of shivering.Timepoint: Shivering will be noted intraoperatively with respect to time of spinal anaesthesia and baby delivery and 30 minutes post-operatively.The time of baby delivery, time of onset of shivering and grade of severity depending on scale will be recorded along with the body temperature.

Secondary

MeasureTime frame
1. Temperature changes from before administration of spinal to end-operative period in both the groups. 2. The number of patients receiving Inj. Pethidine as rescue for shivering in both the groups. 3. The time when shivering develops with respect to spinal and baby delivery and temperature at the onset of shivering. Timepoint: 1.Temperature values will be noted every 10 minutes. 2.Injection Pethidine 25 mg will be administered intravenously for moderate and severe shivering and its requirement will be noted. 3.The time of baby delivery, time of onset of shivering and grade of severity depending on scale will be recorded along with the body temperature.

Countries

India

Contacts

Public ContactDr Niraj Thakur

Jawaharlal Institute of Postgraduate Medical Education and Research

hemavathibalachander@gmail.com9843801642

Outcome results

None listed

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