Skip to content

To see the effect of bupivacaine with and without fentanyl in mothers and children following caesarean section.

The study of haemodynamics and neonatal outcome following spinal anaesthesia with low dose hyperbaric bupivacaine with and without fentanyl in patients undergoing elective caesarean section.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/04/002618
Enrollment
100
Registered
2012-04-30
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- Caesarean section

Interventions

Intervention1: bupivacaine and fentanyl: Inj. bupivacaine 8mg plus Inj. fentanyl 12.5 mcg(0.25cc), spinal route Control Intervention1: bupivacaine and normal saline: Inj.bupivacaine 8mg plus Inj. norm

Sponsors

Department of Biotechnology North Eastern Cell
Lead Sponsor
AGMC Agartala
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: The patients posted for elective caesarean section belonging to ASA(American Society of Anaesthesiologists)grade 1 and 2 only

Exclusion criteria

Exclusion criteria: Patient refusal,any contraindication to neuraxial blockade,pregnancy induced hypertension,placenta praevia, abruptio placentae, intrauterine growth restriction, pre-existing fetal distress.

Design outcomes

Primary

MeasureTime frame
quality of anaesthesia(onsetof action, muscle relaxation, quality of analgesia) and duration of analgesiaTimepoint: From 0 hours till patient request for first dose of analgesic.

Secondary

MeasureTime frame
Adverse effects of intrathecal fentanyl (nausea, vomiting, pruritis, hypotension,bradycardia, respiratory depression)Timepoint: intraoperative and postoperative;Maternal haemodynamics (heart rate, SpO2, NIBP, MAP, respiratory rate). Timepoint: Every two minutes after administration of spinal anaesthesia till the extraction of the newborn and every five minutes till the completion of the surgery, then every 30 minutes till the patient requests for analgesia;Neonatal outcome (Apgar score at one and five minutes after delivery)Timepoint: at one and five minutes after delivery;Rescue dose of analgesicTimepoint: intraoperative and postoperative

Countries

India

Contacts

Public ContactDr Debashis DebRoy

AGMC and GBP Hospital

urbashium781009@rediffmail.com9435113491

Outcome results

None listed

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