Evaluation of drugs midazolam and bupivacaine in spinal anaesthesia when mixed together and when fentanyl and bupivacaine mixed together in caeserian section.

Comparative study of low dose intrathecal Midazolam and Fentanyl as an adjuvant to Bupivacaine heavy in patients undergoing elective caeserian section under spinal anaesthesia -A Prospective Randomized Double Blind Clinical Study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/06/043450

Enrollment

Registered

2022-06-23

Start date

Unknown

Completion date

Unknown

Last updated

2022-06-27

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

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: Spinal Anaesthesia using Inj Bupivacaine heavy Inj Fentanyl: Intrathecally premixed Inj Bupivacaine heavy (2cc/10mg) Inj Fentanyl (0.25cc/12.5mcg) Intervention2: Spinal Anaesthesia usin

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing Elective caesarean section under spinal anesthesia. 2. Age 18-40yrs. 3,ASA I andII. 4.Height -150 cm and above

Exclusion criteria

Exclusion criteria: 1.Patients refuse spinal anesthesia; unwilling to participate in study,unable to communicate. 2. Patients with localized skin infection, haemorrhagic diathesis ,neurological involvement/ gross spinal abnormality,severe anemia. 3.Patients with history of drug allergy to Bupivacaine, fentanyl and midazolam. 4.Patients with cardiac, pulmonary,hepatic or renal disorders. 5 Bad obstetric history, obstetric complications in present pregnancy, evidence of foetal compromise and anomalies. 6 Patients physically dependent on narcotics or benzodiazepines. 7.Patients unable to understand Visual analog scale.

Design outcomes

Primary

Measure	Time frame
â?¢ To evaluate post operative analgesic efficacy of Midazolam and Fentanyl as an adjuvant to Bupivacaine heavy for elective lower segment caesarean section .Timepoint: Time from administration of drug intrathecally till 24hrs.	—

Secondary

Measure	Time frame
To compare sensory characteristics: 1. Onset of sensory block. 2. Highest sensory level achieved.. 3. ,Time to reach highest sensory level, 4. Time of two segment regression from highest level of block 5. Total duration of sensory block. â?¢ To compare motor characteristics 1. Bromage score 2. Onset of motor blockade 3. Maximum motor blockade 4. Time to achieve maximum motor block 5. Duration of motor block â?¢ To compare the haemodynamic parameters (Pulse,SBP,DBP,MAP,Spo2 )in both groups â?¢ To assess the sedation score in both the groups. â?¢ To assess the neonatal outcome in both the groups.(APGAR SCORE) â?¢ To study the side effects of Midazolam and Fentanyl as adjuvants to Bupivacaine heavy as well as complications of spinal anesthesia.(Hypotension,bradycardia,chills,nausea,vomiting, Respiratory depression,pruritus,dryness of mouth,urinary retention) Timepoint: Time from administration of drug intrathecally till 24hrs	—

Measure

Time frame

To compare sensory characteristics: 1. Onset of sensory block. 2. Highest sensory level achieved.. 3. ,Time to reach highest sensory level, 4. Time of two segment regression from highest level of block 5. Total duration of sensory block. â?¢ To compare motor characteristics 1. Bromage score 2. Onset of motor blockade 3. Maximum motor blockade 4. Time to achieve maximum motor block 5. Duration of motor block â?¢ To compare the haemodynamic parameters (Pulse,SBP,DBP,MAP,Spo2 )in both groups â?¢ To assess the sedation score in both the groups. â?¢ To assess the neonatal outcome in both the groups.(APGAR SCORE) â?¢ To study the side effects of Midazolam and Fentanyl as adjuvants to Bupivacaine heavy as well as complications of spinal anesthesia.(Hypotension,bradycardia,chills,nausea,vomiting, Respiratory depression,pruritus,dryness of mouth,urinary retention) Timepoint: Time from administration of drug intrathecally till 24hrs

—

Countries

India

Contacts

Public ContactNidhi Maru

SSG Medical college and hospital,Vadodara

yogi.80patel@gmail.com9879576564

Outcome results

None listed

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