Tachycardia as an Indication for Prophylactic Phenylephrine Injection in Caesarean Section Under Spinal Anesthesia; an Observational Study

NCT ID: NCT06220942

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-05
• Study Completion Date: 2024-05-31

Brief Summary

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

Detailed 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.

Conditions

Anesthesia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

maha sadek El Derh

Assistant professor of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

maha sadek El Derh

Cairo, Heliopolis, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

maha S El Derh, MD

Role: primary

mahasadek81@yahoo.com

01144866675

samar M Abd el tawab, MD

Role: backup

dr_sm.md@hotmail.com

01006236494

Other Identifiers

FMASUR338/2023

Identifier Type: -

Identifier Source: org_study_id