"The Role of 6% Hydroxyethyl starch and Ringers lactate for preloading in patients undergoing elective caesarean section under spinal anaesthesia "

"The Role of 6% Hydroxyethyl starch and Ringers lactate for preloading in patients undergoing elective caesarean section under spinal anaesthesia - A Prospective randomised clinical study "

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/034758

Enrollment

Registered

2021-07-12

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: O00-O9A- Pregnancy, childbirth and the puerperium Health Condition 2: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: Preloading with 6%Hydroxyethylstarch in patients undergoing elective caesarean sectioin under spinal anaesthesia: Baseline haemodynamic parameters noted and monitoring done till the end

Eligibility

Inclusion criteria

Inclusion criteria: ASA I AND II

Exclusion criteria

Exclusion criteria: Unwillingness of the patient. BMI >25kg/meter square, Height less than 152cms. Patients with Multiple gestation. Patients with spine deformity,previous history of spine surgeries. Severe anemia,coagulation abnormalities and bleeding disorders. Patients with active skin lesions over lumbosacral region. Medical disorders like chronic hypertension,diabetes,liver disease,renal diseases(calculi,stenosis,altered renal function tests), and CVS abnormalities(MI,Heart blocks etc).

Design outcomes

Primary

Measure	Time frame
To compare the incidence of hypotension while using 6% HES or Ringers lactate for preloading who are undergoing elective caesarean section under spinal anaesthesia.Timepoint: To compare the incidence of hypotension while using 6% HES or Ringers lactate for preloading who are undergoing elective caesarean section under spinal anaesthesia. Patient will be monitored upto 24hrs after surgey	—

Secondary

Measure	Time frame
To compare the requirement of ephedrine to treat hypotension when preloaded with 6%HES or ringers lactate. To assess the neonatal outcome in both the groups. To study the side effects of HES as well as complications of spinal anesthesia.Timepoint: Patients who develop hypotension will be treated with IV boluses of ephedrine and total requirements will be noted .Other side effects like bradycardia and allergic reactions will be noted and treated accordingly. allergic reactions to HES will be noted. Neonatal outcome will be maesured by APGAR score at 1st and 5th minute of delivery. Patients will be monitored postoperatively every 2hrly till 24hrs	—

Measure

Time frame

To compare the requirement of ephedrine to treat hypotension when preloaded with 6%HES or ringers lactate. To assess the neonatal outcome in both the groups. To study the side effects of HES as well as complications of spinal anesthesia.Timepoint: Patients who develop hypotension will be treated with IV boluses of ephedrine and total requirements will be noted .Other side effects like bradycardia and allergic reactions will be noted and treated accordingly. allergic reactions to HES will be noted. Neonatal outcome will be maesured by APGAR score at 1st and 5th minute of delivery. Patients will be monitored postoperatively every 2hrly till 24hrs

—

Countries

India

Contacts

Public ContactDr Swati Bhatt

Government medical college ,Baroda

drswatibhatt2015@yahoo.com6355626482

Outcome results

None listed

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