A CLINICAL TRIAL TO STUDY THE EFFECTS OF HYPERBARIC BUPIVACAINE AND FENTANYL DRUGS GIVEN EITHER AS A MIXTURE OR SEQUENTIALLY FOR SPINAL ANAESTHESIA IN PATIENTS UNDERGOING CAESAREAN SECTION

Phase 1

Not yet recruiting

• Conditions: Adult ASA I,II parturients with height 145-165 cm and Body mass index 35 kg/m2

• Registration Number: CTRI/2018/03/012602
• Lead Sponsor: Vardhman Mahavir Medical College

Brief Summary

comparison of hyperbaric bupivacaine and fentanyl injected intrathecally either by single syringe or different syringes sequentially .

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-04
• Last Update Posted: 2018-12-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

Adult ASA physical status I, II with height 145-165 cm and Body mass index (BMI) < 35 kg/m2.

Exclusion Criteria

Known coagulation abnormality or bleeding diathesis, local infection at the site of spinal injection, raised intracranial tension, chronic hypertension, severe hypotension, hypovolaemia, cord prolapse, hypersensitivity to local anaesthetic or fentanyl.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of hyperbaric bupivacaine and fentanyl given either as a mixture or sequentially for subarachnoid block in terms of 1) Block characteristics, 2) Haemodynamic parameters 3) Time required to achieve sensory block height (T5) for caesarean section.	Before giving surgical incision

Secondary Outcome Measures

Name	Time	Method
To evaluate the duration of sensory and motor block, total dose of vasopressor and neonatal outcome as assessed by Umbilical cord blood gas analysis, Apgar Score and need for Neonatal Resuscitation in above patients	at the time of giving subarachnoid block, during surgery and post operative period

Trial Locations

Locations (1)

Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029; 🇮🇳 West, DELHI, India

Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029

🇮🇳West, DELHI, India

Dr Rahul Kalshan

Principal investigator

8010886902

rahul.kalshans@gmail.com