To compare and identify which medication among dexmedetomidine and fentanyl as additive to hyperbaric ropivacaine for spinal anaesthesia in patients undergoing removal of uterus surgery is safe and effective.

Phase 3

Completed

• Conditions: Abnormal uterine and vaginal bleeding, unspecified,

• Registration Number: CTRI/2024/03/064274
• Lead Sponsor: Dr M Vivekanandh

Brief Summary

The primary purpose of the protocol is to collect basic details of the patient, record and monitor the vital signs, fill in the information regarding the primary and secondary objectives of the study after the intrathecal drug administration. Objective of this study is to compare the effects and safety of dexmedetomidine as an intrathecal adjuvant to hyperbaric ropivacaine and fentanyl as an intrathecal adjuvant to hyperbaric ropivacaine.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-25
• Study Completion: 2024-08-14
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• 1)patients belonging to ASA class I & class II.
• 2)patients without any severe comorbid diseases.

Exclusion Criteria

• 1)Patients having any absolute contraindications for spinal anaesthesia such as patient not willing, raised intracranial pressure, severe hypovolemia, bleeding diathesis, local infection and cardiac, respiratory, and CNS diseases.
• 2)Pregnant females and those with chronic diseases such as diabetes, hypertension,renal dysfunction, liver disorders and cardiac abnormalities.
• 3)Patients with body mass index >30 kg/m².
• 4)Patients shorter than 150 cm.
• 5)Patients allergic to any of the study drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of Onset and duration of sensory blockade and motor blockade provided by adjuvants Dexmedetomidine and Fentanyl, given with intrathecal Hyperbaric Ropivacaine.	comparison of Onset and duration of sensory blockade and motor blockade provided by adjuvants Dexmedetomidine and Fentanyl, given with intrathecal Hyperbaric Ropivacaine at baseline,at 5 minutes, then every 15 minutes till end of the surgery, and in the postoperative period till blockade regression.

Secondary Outcome Measures

Name	Time	Method
1)Complete sensory & motor blockade attained & time taken for the same.	2)Total duration of analgesia.

Trial Locations

Locations (1)

Karpaga vinayaga medical college hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Karpaga vinayaga medical college hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr M Vivekanandh

Principal investigator

9790228879

peruvivan1711@gmail.com