We want to study about Thermoregulatory effect of intravenous Bupivacaine versus intravenous Bupivacaine andFentanyl for spinal anaesthesia in cesarean section.

A Randomised Study to Evaluate the Thermoregulatory Effects of Bupivacaine v/s Bupivacaine and Fentanyl for Spinal Anaesthesia in Caesarean Sections in SMS Medical College, Jaipur - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099263

Enrollment

Registered

2025-12-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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 Health Condition 2: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Spinal anaesthesia in elective cesarean section 0.5%bupivacaine : To assess the effect of intrathecal intravenous 0.5% 1.8ml of hyperbaric Bupivacaine alone versus intrathecal intrave

Eligibility

Inclusion criteria

Inclusion criteria: 1. Scheduled for elective caesarean section under subarachnoid block (SAB) anaesthesia. 2. Willing to provide written informed consent. 3. Age between 20 and 40 years. 4. Patients belonging to American Society of Anesthesiologists (ASA) class II.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Mean duration of post op analgesiaTimepoint: Baseline At the time of spinal block 3 min 6 min 9 min 12 min 15 min 20 min 25 min 30 min 35 min 40 min 45 min 50 min 55 min 60 min	—

Secondary

Measure	Time frame
Mean Time to Onset of Shivering. Median of Grades of Shivering. (Vanderstappen & Vandermeersch) Mean of Peripheral Temperature at the time of Shivering. Mean of Hemodynamic Parameters (HR, DBP, SBP, MAP, SpO2 ). Proportion of cases who develops side effects (Bradycardia, Vomiting, Nausea, Pruritis Mean of dose of Tramadol requiredTimepoint: Baseline At the time of spinal block 3 min 6 min 9 min 12 min 15 min 20 min 25 min 30 min 35 min 40 min 45 min 50 min 55 min 60 min	—

Measure

Time frame

Mean Time to Onset of Shivering. Median of Grades of Shivering. (Vanderstappen & Vandermeersch) Mean of Peripheral Temperature at the time of Shivering. Mean of Hemodynamic Parameters (HR, DBP, SBP, MAP, SpO2 ). Proportion of cases who develops side effects (Bradycardia, Vomiting, Nausea, Pruritis Mean of dose of Tramadol requiredTimepoint: Baseline At the time of spinal block 3 min 6 min 9 min 12 min 15 min 20 min 25 min 30 min 35 min 40 min 45 min 50 min 55 min 60 min

—

Countries

India

Contacts

Public ContactDr Kajal Kanvatiya

SMS medical college and attached hospital

drsavita020@gmail.com8290969216

Outcome results

None listed

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