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A clinical trial to study the effects of two different doses of spinal drug bupivacaine on blood pressure in patient undergoing elective caesarean section.

Comparative evaluation of single shot subarachnoid block with hyperbaric bupivacaine and CSE with low dose hyperbaric bupivacaine â?¨and fentanyl for caesarean Section - a RCT study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011843
Enrollment
60
Registered
2018-02-12
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- Full term parturient with singleton uncomplicated pregnancy

Interventions

Intervention1: Low Dose group: Low dose bupivacaine and fentanyl in spinal anaesthesia Control Intervention1: Conventional dose group: Bupivacaine in spinal anaesthesia

Sponsors

NKPSIMS and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I-II, Singleton pregnancy of more than 36 weeksâ?? gestation, Uncomplicated pregnancy, with height in 150-170 cm range and BMI up to 26.

Exclusion criteria

Exclusion criteria: Severe pre-eclampsia, with coagulation abnormalities or on therapeutic anticoagulants, those having kyphoscoliosis, pre-existing neurological deficit, any infection at site of injection or altered mental status, known allergies to medications used in the study and patients not willing for the procedure

Design outcomes

Primary

MeasureTime frame
1. Incidence of hypotension between two groups. 2. Intraoperative use of vasopressor drugs between the two groups. 3. Time required to achieve T6 level of blockade between two groups.Timepoint: Vitals noted every 2 minute till 10 mins and there after every 5 mins till end of surgery.

Secondary

MeasureTime frame
1. Compare between two groups incidence of nausea and vomiting after giving Inj. Ranitidine 1mg/kg i.v. and Inj. Ondansetron 0.1mg/kg pre-operatively. 2. Neonatal outcome using APGAR scores. 3. Compare the surgical conditions in the two groups with respect to abdominal relaxation.Timepoint: Vitals noted every 2 minute till 10 mins and there after every 5 mins till end of surgery.

Countries

India

Contacts

Public ContactDr Rahul Jibhakate

NKPSIMS AND RESEACH CENTER

RAHULJIBHAKATE@GMAIL.COM7709506485

Outcome results

None listed

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