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Comparison between two different drugs used in increasing blood pressure after spinal anaesthesia for caesarean section surgeries

A comparative study of the effectiveness of preoperative, prophylactic, intramuscular Glycopyrrolate versus Ephedrine in the prevention of post - spinal hypotension in parturients undergoing elective Caesarean delivery: a prospective, randomised control trial - GLYCOVSEPH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012866
Enrollment
112
Registered
2018-03-26
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- The trial studied incidence and severity of post spinal hypotension in elective LSCS in parturients who were receiving pharmacological prophylaxi to prevent said maternal hypotension.

Interventions

Intervention1: EPHEDRINE: Ephedrine is a mixed action sympathomimetic drug which is commonly used to prevent or treat post spinal hypotension in caesarean sections. Control Intervention1: GLYCOPYRROLA

Sponsors

Amit Vikram Das
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists Physical Status II (TWO) - Pregnancy with/without well controlled gestational diabetes/hypothyroidism/asthma 2. Body Mass Index range : 18 - 30 kg/m2 3. Nil Per Oral since 6 hours for solids and 3 hours for liquids.

Exclusion criteria

Exclusion criteria: 1. Baseline systolic blood pressure 2. Patients with anaemia (Hb 3. History of hypertension (gestational/chronic) 4. History of cardiovascular and cerebrovascular disease 5. Other contraindications to spinal anaesthesia 6. Subject refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
EPHEDRINE WAS FOUND TO BE BETTER THAN GLYCOPYRROLATE IN PREVENTING POST SPINAL HYPOTENSION IN PARTURIENTS UNDERGOING ELECTIVE CAESAREAN DELIVERYTimepoint: -Baseline heart rate and blood pressure was the first recorded reading after shifting patient to OT table. -Intramuscular study drug given thereafter. -After IM injection, 3 successive readings of blood pressure and heart rate at 5 minute intervals taken. - Spinal anaesthetic given 15 minutes after IM injection. - After spinal, heart rate and blood pressure measured every minute for first 5 minutes and then every 5 minutes for 55 minutes or till the end of the surgery, whichever is sooner.

Secondary

MeasureTime frame
Parturients receiving intramuscular ephedrine prophylaxis required lesser rescue drug phenylephrine for correction of any consequent hypotension, as compared to the glycopyrrolate group.Timepoint: Phenylephrine was administered in boluses of 50 mcg if systolic blood pressure dropped less than 100 mmHg with in 2-3 mins after giving spinal anaesthesia

Countries

India

Contacts

Public ContactAmit Vikram Das

Kasturba Medical College, Manipal

basavaraj.herekar8@gmail.com9686150571

Outcome results

None listed

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