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comparing two drugs midazolam and fentanyl used in spinal anesthesia for prolonged pain relief post surgery in patients undergoing caesarean section

Comparative Study of Analgesic Efficacy of Intrathecal Fentanyl versus Intrathecal Midazolam as Adjuvant to Hyperbaric Bupivacaine in Elective Caesarean Section - A Randomized Double Blind clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048892
Enrollment
60
Registered
2023-01-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Interventions

Intervention1: Spinal Anesthesia: The patient included in the study after obtaining informed written consent shall be evaluated for as per protocol including requisite pre-operative clinical evaluatio

Sponsors

Sikkim Manipal Institute of medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA physical status I 2.ASA physical status II 3.Age from 18-35 years 4.Scheduled to undergo elective caesarean section under spinal anesthesia

Exclusion criteria

Exclusion criteria: ASA III or IV patients. ? Patients’ refusal for spinal anesthesia. ? Patients physically dependent on narcotics or benzodiazepine. ? Patients with history of drug allergy to fentanyl and midazolam ? Patients with gross spinal abnormality, localized skin sepsis, haemorrhagic diathesis or neurological involvement/ diseases and any contraindication for spine. ? Head injury cases. ? Patients with cardiac, pulmonary, hepatic or renal disorders. ? Patients with peripheral neuropathy. ? Patients having inadequate sub arachnoid blockade and who are later supplemented by general anesthesia. ? Chronic pain at puncture site. ? Patients who are unable to communicate.

Design outcomes

Primary

MeasureTime frame
To study and compare the Onset, Duration of Analgesia • Consumption of additional Analgesics in first Post-Operative 12 HoursTimepoint: 12 hours

Secondary

MeasureTime frame
To study Hemodynamic changes • Sedative Effect on Mother (Ramsay sedation score) and on New Born (APGAR Score) • Associated adverse effect during the study period (Nausea, Vomiting, shivering, Pruritis, Sedation, Hypotension, Bradycardia Hypersensitive Reaction, Respiratory DepressionTimepoint: 12 hours

Countries

India

Contacts

Public ContactDr B K Gandhi

Sikkim Manipal institute of medical sciences

colbkg@gmail.com9831779215

Outcome results

None listed

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