Comparison of fentanyl and midazolam in spinal anaesthesia in lower segment caesarean section patients

A comparative study to evaluate efficacy of intrathecal fentanyl and intrathecal midazolam added as adjuvant to Bupivacaine 0.5 (heavy) in patients undergoing LSCs - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059618

Enrollment

Registered

2023-11-07

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Fentanyl: 0.3 milliliters Fentanyl as adjuvant to Bupivacaine 0.5 % (heavy) while giving spinal anaesthesia Control Intervention1: FENTANYL: 0.3 MILLILITRES FENTANYL AS ADJUVANT Control

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 18 to 35years 2. Patients undergoing cesarean section 3. Primi gravida with gestational age more than 37 weeks 4. Body mass index 20 to 29.9kg/meter square 5. Intact amniotic membrane 6. No history of bleeding tendency or coagulopathies or with any neuromuscular disorders or neurological diseases. 7. No previous uterine operations except cesarean sections 8. Living fetus 9. ASA II 10. Patients giving informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are multigravida, previous LSCS. 2. ASA CLASS 3 AND CLASS 4. 3. Patients refusal. 4. Patients with any co-morbities. 5. Patients with infection at the site of injection. 6. Patients with sensitivity to local anaesthetic agent, fentanyl and midazolam.

Design outcomes

Primary

Measure	Time frame
To compare and to evaluate efficacy of intrathecal Fentanyl and intrathecal Midazolam added as adjuvant to Bupivacaine 0.5% (heavy) in patients undergoing lower segment caesarean sectionTimepoint: 24 hours	—

Secondary

Measure	Time frame
Compare the effect of fentanyl & midazolam on intraoperative haemodynamics The Onset & Duration of Sensory And Motor Block To compare the role of fentanyl and midazolam as an adjuvant for prevention of side effects To access APGAR score Timepoint: 24 HOURS	—

Countries

India

Contacts

Public ContactRutuja Gohad

Acharya Vinobha Bhave Rural Hospital, JMNC

doctorchandak@gmail.com9422903551

Outcome results

None listed

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