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Clinical Trials/CTRI/2022/10/046431
CTRI/2022/10/046431Not yet recruitingPhase 4

Comparison of hemodynamic changes between phenylephrine and glycopyrrolate group after spinal anesthesia for caesarean delivery

krishna institute of medical sciences1 site in 1 country60 target enrollmentStarted: October 13, 2022Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
1.TO study and compare the severity of hypotension and bradycardia in parturients undergoing caesarean section under spinal anesthesia

Study Overview

Brief Summary

AIM To study the efficacy of prophylactically intravenous administration of phenylephrine and glycopyrrolate to attenuate the hemodynamic responses of parturient during cesarean delivery under spinal anesthesia.

  OBJECTIVES To study and compare the severity of hypotension and bradycardia in parturient undergoing cesarean section under spinal anesthesia. And to study and compare the side effects i.e. nausea and vomiting in parturient undergoing cesarean section under spinal anesthesia

METHOD In my study  patients posted for elective cesarean section  under spinal anesthesia will be randomly allocated into two groups (30 each) , Phenylephrine group [P] and glycopyrrolate group [G]  after explaining the procedure to patient and informed consent .

PROCEDURE : Pre anesthetic checkup and preparation : In my study  patients posted for elective cesarean section  under spinal anesthesia will be randomly allocated into two groups (30 each ) , phenylephrine group [P] and glycopyrrolate group [G]  after explaining the procedure to patient and written informed consent . An 18-gauge intravenous cannula will be established in a forearm and preloaded with Hartmann solution of 10ml/kg .Premedication with Inj Ranitidine 0.5-1 mg/kg and Inj Metaclopramide 0.1-0.15 mg/kg will be  given in recovery to all patients. After shifting the patient in OR standard monitors i.e., heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP) and oxygen saturation (sPO2) will be connected and baseline readings will be recorded . Spinal Anesthesia will be given to  patients in left lateral position with 25guage spinal needle at L3-4 or L4-5 vertebral interspace with 0.5% heavy Bupivacaine 2.2ml . Immediately after spinal anesthesia.

In P GROUP: The phenylephrine infusion will be started at a rate of 50 μg/min for 15 min and the hemodynamic values will be recorded at [1,3,5,7,9,11,13,15mins]. and at the same time 1cc of normal saline in 2cc syringe for double blinding. If the SBP is 30% above the baseline, the infusion will be stopped. If SBP ≤ 30%of baseline for 2 consecutive readings, despite the phenylephrine infusion, will be treated with a bolus of phenylephrine 50 μg.   If HR falls <60bpm Inj glycopyrrolate will be given IV (0.2mg)  .Total phenylephrine infusion dose given over 15mins will be recorded.

In G GROUP:  In group G , glycopyrrolate will be injected 1cc of 0.2 mg  intravenously in 2cc syringe after spinal anesthesia . If SBP is 30% below the baseline, phenylephrine bolus dose of 50mcg will be  given and recorded.If HR falls <60bpm  Inj Atropine will be given IV (0.6mg) in 1cc  .Hemodynamic changes will be recorderedover 15mins ( 1,3 ,5,7,9,11,13,15mins) .

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 35.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Parturients belonging to ASA 1 and 2 Age 20 to 35 years.

Exclusion Criteria

  • Patients with cardiovascular disease Patients with cerebrovascular disease Pregnancy related hypertensive disease and diabetes mellitus Height less than 150cms or more than 180cms Weight less than 50kg or more than 100kgs Known fetal abnormalities Contraindications to glycopyrrolate Fever Twin pregnancies.

Outcomes

Primary Outcomes

1.TO study and compare the severity of hypotension and bradycardia in parturients undergoing caesarean section under spinal anesthesia

Time Frame: 1. maternal data such as age , BMI , baseline heart rate (HR) , systolic and diastolic blood pressure (SBP,DBP) , mean arterail pressure (MAP) | 2. HR,SBP,DBP measured for 15mins after induction of subarachnoid block . | 3.incidence if hemodynamic adverse effects.

2.And to study and compare the side effects nausea and vomiting

Time Frame: 1. maternal data such as age , BMI , baseline heart rate (HR) , systolic and diastolic blood pressure (SBP,DBP) , mean arterail pressure (MAP) | 2. HR,SBP,DBP measured for 15mins after induction of subarachnoid block . | 3.incidence if hemodynamic adverse effects.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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