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

Phase 2

Not yet recruiting

• Conditions: Encounter for full-term uncomplicated delivery,

• Registration Number: CTRI/2023/11/059618
• Lead Sponsor: Acharya Vinobha Bhave Rural Hospital

Brief Summary

Spinal anaesthesiais preferred for lower abdominal and lower limb surgeries especially in cesarean sections due to longduration of analgesic effect, lesser thromboemolic events, because it is economical,easy to administer and fewer adverse effects in mother and infant.Bupivacaine is the most popular local anaesthetic forsubarachnoid blockade because of less neurotoxicity. Intrathecal bupivacainealone may be insufficient to provide prolonged post-operative analgesia, evenwith high sensory block. So, various adjuvants are used like ketamine,midazolam, clonidine, fentanyl, neostigmine etc. to prolongthe effect of local anaesthetic. Fentanyl, an opioid, after intrathecal administrationdiffuses into epidural space and subsequently into the plasma, suggesting that it acts not onlythrough spinal opioid receptors but also systemically. Fentanyl added tobupivacaine intrathecally provides better surgical anaesthesia.  Midazolam, a benzodiazepine is an anxiolytic andsedative, it when administered intrathecally has antinociceptive properties.

**PRIMARY OBJECTIVE:**COMPARISIONOF DURATION OF ANALGESIA BETWEEN FENTANYL AND MIDAZOLAM ASAN ADJUVANT WITH BUPIVACAINE.

**SECONDARY OBJECTIVE:**

1. Comparethe effect of fentanyl and midazolam on intraoperativehaemodynamics.

2. The Onset and Duration of Sensory And Motor Block .

3. Tocompare the role of fentanyl and midazolam as an adjuvant forprevention of side effects like nausea, vomiting, shivering, pruritis.

4. To accessAPGAR score.

**METHODOLOGY: Patients for the study will be conductedon 60 patients fulfilling the inclusion criteria.****Patients will be randomly allocated into 2study groups who will be administered with the following combination of drugs.**

GROUP A(n=30): 15 mcg Fentanyl intrathecal (0.3ml) with 2ml 0.5% Bupivacaine

GROUP B (n=30):0.3 mg Midazolam intrathecal (0.3ml) with 2ml 0.5% Bupivacaine and the onset of duration of sensory and motor blockade , hemodynamic parameters, post operative analgesia and side effects will be recorded.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-10-22
• Study Start: 2024-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 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.
• No previous uterine operations except cesarean sections 8.
• Living fetus 9.
• Patients giving informed consent.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 section	24 hours

Secondary Outcome Measures

Name	Time	Method
Compare the effect of fentanyl & midazolam on	intraoperative haemodynamics

Trial Locations

Locations (1)

Acharya Vinobha Bhave Rural Hospital; 🇮🇳 Wardha, MAHARASHTRA, India

Acharya Vinobha Bhave Rural Hospital

🇮🇳Wardha, MAHARASHTRA, India

Rutuja Gohad

Principal investigator

9623126644

rutujagohad29@gmail.com