A study to show the effectiveness of giving a drug vasopressor before hand to prevent the fall in blood presssure following injection through lower back in cesarean sections.

Not yet recruiting

• Conditions: Obstetrics,

• Registration Number: CTRI/2021/06/034138
• Lead Sponsor: Office of principal Midnapore medical college and hospital

Brief Summary

**Proposed topicof research****:**

EFFECTIVENESS OF PROPHYLACTIC NOREPINEPHRINEINFUSION IN PREVENTING HYPOTENSION FOLLOWING SPINAL ANESTHESIA IN CESAREANSECTION – A PROSPECTIVE,RANDOMIZED ,DOUBLE BLIND STUDY.

**Objective of theproposed research**:

To study and know about the efficacy of prophylacticinfusion of  Norepinephrine inmaintaining the systolicblood pressure within 20% of baseline following spinalanesthesia in parturientundergoing elective cesarean section.

**Background ofpresent study**:

Hypotension is the common complication ofspinal anesthesia caused by the loss of systemic vascular resistance and leadsto detrimental effects to both mother and foetus due to decrease in Uteroplacentaloutflow.Various vasopressors have been tried from Ephedrine to the Phenylephrine and Mephenterminewith Phenyleprine being the gold standard. Now the search  for alternative vasopressor is focusedon Norepinephrine  because of its ð›¼-adrenergic andmild ð›½-adrenergic effects. Effectivenessof prophylactic infusion of Norepinephrine in maintaining the blood pressurewithin 20% of the baselinewill be studied in this study.

**Methodology** :

Thisstudy is the Institution based , Prospective , Randomized, Double blinded studybased on the healthy women undergoing elective cesarean section under spinal anesthesiain obstetrics operation room complexes of Midnapore Medical College & hospital.In this study total of  patients aretaken and divided into two 100 groups with 50 in each group, in which one groupreceives prophylactic infusion of Norepinephrine (study group) and otherreceives prophylactic infusion of normal saline (control group).

**Expected outcome**:

weexpect that administration of prophylactic Norepinephrine infusion will be verymuch helpful in maintaining the systolic blood pressure within 20% of thebaseline following the spinal anesthesia and also there will be no remarkabledetrimental effects on the Neonates which will be assessed by the APGAR scoresand umbilical cord blood gas analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-07
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1.All ASA criteria I and II 2.The patients giving valid consent 3.Elective LSCS 4.Patients age 18 to 35 years 5.Term Singleton pregnancy.

Exclusion Criteria

• 1.Patients’ refusal to take part in the study.
• 2.Patients with co-morbidity of cardiovascular system, respiratory system, Neurological and hepatic renal disorders.
• 3.Patients with contraindications to spinal anesthesia like local site infection, coagulation disorders.
• 4.Patients with obstetric complication like breech presentation,pregnancy induced hypertension, gestational diabetes mellitus,HELLP syndrome and other coagulation and auto immune disorders 5.Patients with neonatal compromise like fetal bradycardia , meconium stained liquor ,IUGR.
• 6.Failed spinal , repeat spinal , patchy spinal , conversion to General anesthesia at any moment of surgery is excluded from study.
• 7.Patient with history of allergy to study drugs.
• 8.Height < 140 cm and >180cm.
• 9.Weight <50kg and >100kg.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.To record the number of hypotension episodes in both groups.	Non invasive BP monitoring started after intrathecal injection set at one minute time interval until delivery and followed by 3 minutes interval after delivery till the completion. The time of first episode of hypotension noted if it occurred
1.To monitor and record haemodynamic parameters like Systolic blood pressure,Diastolic blood pressure,Mean arterial pressure and heart rate at specified time intervals and compare between study.	Non invasive BP monitoring started after intrathecal injection set at one minute time interval until delivery and followed by 3 minutes interval after delivery till the completion. The time of first episode of hypotension noted if it occurred

Secondary Outcome Measures

Name	Time	Method
Incidence of Tachycardia, hypertension, bradycardia, intra operative nausea and vomiting, other complications and comparision of neonatal apgar scores and umbilical cord blood analysis	1 min interval from start of intraoperative period to baby delivery and 3 minutes intervals till end of operation. Apgar score will be taken at 1 minute and 5 minutes of baby delivery

Trial Locations

Locations (1)

Midnapore medical college and hospital; 🇮🇳 Medinipur, WEST BENGAL, India

Midnapore medical college and hospital

🇮🇳Medinipur, WEST BENGAL, India

R Vidyakar

Principal investigator

7639147776

vidyakar02@gmail.com