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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

COMPARATIVE STUDY OF HYPERBARIC BUPIVACAINE AND FENTANYL GIVEN EITHER AS A MIXTURE OR SEQUENTIALLY FOR SUBARACHNOID BLOCK IN PATIENTS UNDERGOING CAESAREAN SECTION

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012602
Enrollment
180
Registered
2018-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Adult ASA I,II parturients with height 145-165 cm and Body mass index 35 kg/m2

Interventions

Intervention1: Is sequential administration of intrathecal hyperbaric bupivacaine and fentanyl superior to mixed medications in terms of occurrence of hypotensive episodes, block characteristics and v

Sponsors

Vardhman Mahavir Medical College
Lead Sponsor
Dr Ranju Gandhi
Collaborator

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Before giving surgical incision

Secondary

MeasureTime frame
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 patientsTimepoint: at the time of giving subarachnoid block, during surgery and post operative period

Countries

India

Contacts

Public ContactDr Rahul Kalshan

Vardhman Mahavir Medical College

icu_era@yahoo.co.in9818941341

Outcome results

None listed

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