Comparison of two different volumes of intravenous fluid administration after spinal anaesthesia for prevention of hypotension in elective caesarean section.

Not yet recruiting

• Conditions: Medical and Surgical, (2) ICD-10 Condition: Y838||Other surgical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure,

• Registration Number: CTRI/2021/02/031380
• Lead Sponsor: Vijayanagar Institute Of Medical Sciences

Brief Summary

Spinal anesthesia is considered the technique of choice for elective caesarean delivery due to its technical simplicity, safety, effectiveness and reduced cost. However, it commonly results in hypotension (incidence approximately 80%), which may have significant maternal and foetal adverse effects.Techniques such as fluid loading (crystalloid and colloid), vasopressor administration (α and β adrenergic agonists), lower limb compression, etc have been shown to decrease the incidence of spinal-induced hypotension (SIH) during caesarean section.Fluid co-loading appears to be more physiological and rational approach as the maximal effect can be achieved at the time of onset of the block. Crystalloids such as Ringer Lactate and Normal Saline have been found to be useful as co-load instead of preload in elective caesarean sections under spinal anaesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-26
• Last Update Posted: 2021-05-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

• Primiparous and multiparous parturient women with 37–42 weeks of gestation 1.Singleton pregnancy Posted for elective caesarean section under spinal anaesthesia.
• 2.ASA grade II 3.Normal foetal profile 4.Patients only on maintenance flow of IV fluids.

Exclusion Criteria

1.Contraindication for or refusal of spinal anaesthesia 2.Hypertension (SBP >140 mm Hg or DBP >90 mm Hg) due to Chronic or gestational hypertension or preeclampsia 3.Cardiovascular and/or cerebrovascular diseases 4.Diabetes mellitus 5.Hypersensitivity to fentanyl or bupivacaine 6.Obesity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the effect of varying volumes of crystalloid co-loading in preventing hypotension in caesarean section under spinal anaesthesia.	After spinal anaesthesia.

Secondary Outcome Measures

Name	Time	Method
To assess the requirement of vasopressors, other haemodynamic changes, neonatal outcomes and others.	After spinal anaesthesia

Trial Locations

Locations (1)

Vijayanagar Institute Of Medical Sciences; 🇮🇳 Bellary, KARNATAKA, India

Vijayanagar Institute Of Medical Sciences

🇮🇳Bellary, KARNATAKA, India

Ashwini P

Principal investigator

9108238514

ashpatil25101994@gmail.com