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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06220942
Other study ID # FMASUR338/2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 5, 2023
Est. completion date May 2024

Study information

Verified date January 2024
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The value of phenylephrine administration in response to tachycardia in preventing hypotension after spinal anesthesia in elective cesarean section.


Description:

This observational study will take place at Ain Shams University Maternity hospitals, Cairo, Egypt. All patients will sign written informed consent before inclusion. Sample size: Using PASS 15 program for sample size calculation, setting confidence level at 95% and margin of error at 0.05, it is estimated that sample size of 80 women will be needed to detect an expected incidence rate of hypotension after phenylephrine administration of 30% "Hasanin et al., 2019" Inclusion criteria: ASA II pregnant female planned for elective C.S., aged between 18 -35 years old. Exclusion criteria: Emergency CS, Complicated CS (Severe bleeding, organ injury, uterine atony), ASA III, VI & patients with cardiovascular diseases For all pregnant females including whose in the study group, preoperative labs will be done including ( CBC, INR, Liver function & Kidney function) , oral and written informed consents will be taken from the patients with explanation of the spinal anesthesia and expected complications. In OR wide pore IV access and preload started with crystalloids, full standard monitoring, spinal anesthesia will be performed by the expert anesthetist. The pregnant female will be in the sitting position and complete sterilization of her back, local anesthesia by 5 ml lidocaine 1% then the spinal needle (Pencil point 27 G) introduced between L4-5 and injection of (50 µg fentanyl + bupivacaine 0.5%) in total volume between 1.8 - 2.3 according to patient's height. Then patient will lie supine with head elevated 30 degrees by a bellow and start recording the data just after spinal anesthesia. Phenylephrine will be given in a dose of 50 µg IV immediately if the heart rate increases ≥ 20 % of baseline. Then blood pressure & HR will be recorded after the administration of phenylephrine and every 5 minutes. Any further doses given will be recorded.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date May 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - ASA II pregnant female planned for elective C.S., aged between 18 -35 years old. Exclusion Criteria: - Emergency CS, Complicated CS (Severe bleeding, organ injury, uterine atony), ASA III, VI patients with cardiovascular diseases

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Phenylephrine
Pregnant female presented for C.S. after receiving spinal anesthesia, recording the vital data, phenylephrine will be given in a dose of 50 µg IV immediately if the heart rate increases = 20 % of baseline

Locations

Country Name City State
Egypt maha sadek El Derh Cairo Heliopolis

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of Hypotension Avoidance of Hypotension Avoidance of Hypotension Measure number of hypotensive episodes that would occur after injection of prophylactic phenylephrine for caesarean section ,by spinal anesthesia all through the procedure (cesarean section)
Secondary Apgar score in neonates. Number of phenylephrine doses. Nausea & vomiting after spinal anesthesia. Measure Apgar score of neonate after delivery and compare the results with other neonate whose parturients that did not receive prophylactic phenylephrine all through the procedure (cesarean section)
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