Skip to content

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 operation

A double blinded prospective randomised control study of pre-operative administration of intravenous Mephentermine vs intramuscular Mephentermine in preventing post spinal hypotension in Caesarean section

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033379
Enrollment
120
Registered
2021-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 1- Obstetrics

Interventions

Intervention1: Pre operative administration of mephentermine or placebo before spinal anaesthesia: Preoperative administration intravenous mephentermine in one group along with intramuscular placebo,

Sponsors

Office of the Principal Midnapore Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All pregnant mothers posted for lower segment caesarean section under spinal anaesthesia and can give informed consent for participation.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Other parameters includes cumulative drug doses required in the groups and amount of ST changes in the 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

Countries

India

Contacts

Public ContactArun Kumar Mandi

Midnapore Medical College and Hospital

sumanc24@gmail.com9830234881

Outcome results

None listed

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