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

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/01/048892
• Lead Sponsor: Sikkim Manipal Institute of medical sciences

Brief Summary

primary purpose of the study :

To Compare  Analgesic Efficacy of Intrathecal Fentanyl versus Intrathecal Midazolam as Adjuvant in spinal anesthesia in Elective Caesarean Section for period of 12 hours

study hypothesis:

midazolam may provide better analgesia than intrathecal fentanyl

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-15
• Study Completion: 2024-01-02
• Last Update Posted: 2024-10-06

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study and compare the Onset, Duration of Analgesia	12 hours
• Consumption of additional Analgesics in first Post-Operative 12 Hours	12 hours

Secondary Outcome Measures

Name	Time	Method
To study Hemodynamic changes	• Sedative Effect on Mother (Ramsay sedation score) and on New Born (APGAR Score)

Trial Locations

Locations (1)

Central Referral Hospital , sikkim manipal institute of medical sciences; 🇮🇳 East, SIKKIM, India

Central Referral Hospital , sikkim manipal institute of medical sciences

🇮🇳East, SIKKIM, India

Dr Gandam Raju

Principal investigator

9620301010

drrajugandham@gmail.com