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Comparison between low dose and high dose spinal anaesthesia using bupivacaine heavy with fentanyl in combined spinal epidural anaesthesia during elective caesarean delivery

Comparison between low dose and high dose intrathecal hyperbaric bupivacaine with fentanyl in combined spinal epidural anaesthesia during elective caesarean section - LDCSEA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034005
Enrollment
100
Registered
2021-06-04
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: O- Medical and Surgical Health Condition 2: 1- Obstetrics

Interventions

Intervention1: Intrathecal low dose 7 mg hyperbaric bupivacaine with 20 microgram fentanyl in combined spinal epidural anaesthesia during elective caesarean section: 50 parturients wiil be received l

Sponsors

Office of The Principal Midnapore Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 19 years to 40 years 2. Singleton pregnancy 3. Term gestation (37 to 42 weeks) 4. Elective caesarean section 5. ASA grdae I and II

Exclusion criteria

Exclusion criteria: 1. Age below 19 years and more than 40 years 2. Significant foetal concern like congenital anomaly, IUGR etc 3. Chronic hypertension 4. Gestational hypertension 5. Pre eclampsia 6. Diabetes mellitus 7. Any contraindications to combined spinal epidural anaesthesia 8. Patients with cardiovascular diseases, respiratory diseases, hepatic diseases, renal diseases, endocrine diseases, neurological diseases and psychiatric diseases

Design outcomes

Primary

MeasureTime frame
To compare the incidence of hypotension among the study groups receiving low dose and high dose intrathecal hyperbaric bupivacaine with fentanyl in combined spinal epidural anaesthesia during elective caesarean section (Hypotension is defined as systolic blood pressure less than 100 mm Hg or decrease more than 20% from baseline and or mean blood pressure less than 65 mm Hg or decrease more than 20% from baseline)Timepoint: First before operation baseline parameters will be recorded. Then every minute for first 10 minutes after CSEA. Then every 2 minutes till the delivery of the baby.—

Secondary

MeasureTime frame
To observe neonatal Apgar score and to compare umbilical artery blood gas analysisTimepoint: Apgar score will be observed at 1 and 5 minutes. Umbilical artey blood gas analysis will be done just after delivery of the baby.—

Countries

India

Contacts

Public ContactDR ANURUP PAKHIRA

Midnapore Medical College and Hospital

bjoybnrjee@gmail.com9332132242

Outcome results

None listed

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