A study to compare the effect of mephentermine (it increases blood pressure) by two different routes, in the vein or in the muscle, when it is administered just prior to ceasarean operation to prevent fall in blood pressure after giving spinal anaesthesia during operatio
- Conditions
- Health Condition 1: 1- Obstetrics
- Registration Number
- CTRI/2021/05/033379
- Lead Sponsor
- Office of the Principal Midnapore Medical College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 67
All pregnant mothers posted for lower
segment caesarean section under spinal anaesthesia and can give informed consent for
participation.
i. Less than 18 years of age
ii. ASA grade III & above
iii. More than 35 years of age
iv. Having 2 lower segment caesarean section previously
v. Having systolic blood pressure more than 140 mm Hg or diastolic blood pressure more
than 90 mm Hg pre operatively
vi. On anti-hypertensive medication(s)
vii. Patients having gestational diabetes mellitus
viii. Having Twin or multifetal pregnancy
ix. Refusing to give consent
x. Any cases where repeat spinal administration will be needed (Failed Spinal).
xi. Any cases which may be needed to be converted in to general anaesthesia
xii. Contraindication to spinal anaesthesia
xiii. Patients having severe pallor
xiv. Any operation lasting for more than 90 minutes
xv. Foetal malformation or malpresentation
xvi. Drug allergy to study drugs
xvii. Any cases which require other rescue vasopressors during the procedure
xviii. Emergency cases like
1. Foetal bradycardia
2. Impending rupture
3. heart disease
4. ante partum haemorrhage
5. Cord prolapses
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the incidences of hypotension among the study groups receiving pre operative mephentermine by intravascular route or intramuscular group to the placebo groupTimepoint: After administration of the drugs and spinal anaesthesia, data will be recorded for blood pressure, heart rate, saturation, ECG changes at 5minutes interval in intra-operative period for first 30 minutes, 10minutes for the remaining intraoperative period and 2 hours post-operatively. Pre operative vitals will be taken as baseline.
- Secondary Outcome Measures
Name Time Method Other parameters includes cumulative drug doses required in the groups and amount of ST changes in the <br/ ><br>intra-operative periodTimepoint: Same as that for Primary outcomes, that is at every 5 minutes interval for first 30 minutes and then every 10 minutes interval for the remaining intra operative period