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Comparison of Bupivacaine used alone versus mixture of Bupivacaine and Dexmedetomidine used for giving spinal anaesthesia for Caesarean surgery

Evaluation of the effects of different doses of dexmedetomidine added as adjuvant to bupivacaine in subarachnoid blocks for elective caesarean section - A prospective, randomized, triple-blind controlled study - DBCS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/030151
Enrollment
80
Registered
2020-12-31
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: N998- Other intraoperative and postprocedural complications and disorders of genitourinary system

Interventions

Intervention1: Our study is a 4 arm study, the intervension agent in our study is Bupivacaine heavy 0.5% with dexmedetomidine in different doses in the 3 arms and Bupivacaine heavy 0.5% without dexmed

Sponsors

Dr Ramana Reddy MV
Lead Sponsor
Gayatri Vidya Parishad Institute of Health Care and Medical Technology
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Eighty adult patients of age between 20 and 40 yrs, height between 145 and 170 cm and of American Society of Anaesthesiologists (ASA) grade I and II, attending our medical college hospital with uncomplicated singleton pregnancies of more than 36 weeks of gestation for elective lower segment caesarean surgeries

Exclusion criteria

Exclusion criteria: patients with known allergy to study drugs, patient refusal of local anaesthetic block, patients suffering from neurological disorders, psychiatric disorders, mental retardation, uncontrolled hypertension and diabetes mellitus, coagulation or bleeding abnormalities, severe spinal deformity, history of preeclampsia, twin gestations, infection at spinal injection site or any contraindication to spinal anaesthesia and cases posted for emergency caesarean section

Design outcomes

Primary

MeasureTime frame
differences in the duration of the analgesia and motor and sensory blockTimepoint: Sensory blockade was tested at one minute interval till the onset of sensory blockade and thereafter at 2 min intervals till the maximum level of sensory blockade was achieved and subsequently at every 5 min during first 30 min, then at every 15 min up to 120 min, and thereafter at 30 min intervals until complete recovery

Secondary

MeasureTime frame
The differences in the duration of onset of the motor and sensory block, differences in haemodynamic variables like heart rate (HR), mean arterial pressure (MAP),respiratory rate( RR) and arterial oxygen saturation (SaO2), time for the complete motor recovery ( Bromage grade 1), total dose of rescue analgesics administered during the 1st 24 hours of post operative period, neonatal Apgar scores at one minute and 5 minutes after deliveryTimepoint: At 5 minute intervals from the time of giving spinal anaesthesia to 1st 24 hours of the post-operative period

Countries

India

Contacts

Public ContactDr Ramanareddy MV

Gayatri Vidya Parishad Institute of Health Care and Medical Technology

drramanareddymoolagani@gmail.com9908232415

Outcome results

None listed

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