Condition 1: Hypotension. Condition 2: Hypotension due to drugs. Hypotension Hypotension due to drugs
Conditions
Interventions
Intervention 1: Intervention group: Candidates for cesarean section under spinal anesthesia received two drops of phenylephrine (0.5%) in each nostril
administration was performed 5 minutes before spinal anesthesia. Intervention 2: Control group: Patients received two drops of normal saline (physiological serum) in each nostril
administration was performed 5 minutes before spinal anesthesia.
Sponsors
Bandare-abbas University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Patients undergoing elective cesarean section surgery Patients aged 18 to 55 years ASA physical status class I-II Requirement for spinal anesthesia for elective cesarean section surgery
Exclusion criteria
Exclusion criteria: Allergy to phenylephrine Serious cardiovascular problems Hypertension Preeclampsia Patient refusal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of hypotension (defined as a decrease of more than 20% in systolic blood pressure or systolic blood pressure less than 90 mmHg) following spinal anesthesia. Timepoint: From the time of spinal anesthesia injection until 30 minutes after injection. Method of measurement: Non-invasive measurement of blood pressure using vital signs monitor and recording in the patient's chart.;Need for additional vasopressors (such as etanephrine or ephedrine) to manage hypotension. Timepoint: From the time of spinal anesthesia injection until the end of surgery. Method of measurement: Recording the dose and frequency of vasopressor administration in the anesthesia record.;Occurrence of potential side effects caused by the use of phenylephrine drops (such as headache, nausea, bradycardia, or nasal congestion). Timepoint: From the time of drop instillation until 24 hours after surgery. Method of measurement: Patient questioning and clinical examination by the anesthesiologist. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of nausea and vomiting during surgery or in recovery. Timepoint: From the start of surgery until discharge from the recovery room. Method of measurement: Clinical assessment and patient report; grading based on a standard scale (such as a 0 to 3 scale).;Occurrence of allergic reactions or nasal side effects caused by phenylephrine drops. Timepoint: Up to 24 hours after drop instillation. Method of measurement: Nasal examination and questioning the patient about symptoms such as burning, dryness, or runny nose.;Neonatal status in the first moments of life (Apgar score). Timepoint: At 1 minute and 5 minutes after birth. Method of measurement: Assessment by a pediatrician based on 5 standard criteria (heart rate, respiration, reflex, muscle tone, color).;Need for rescue treatments for hypotension (number of doses and total dose of ephedrine or other vasopressors). Timepoint: From anesthesia until the end of surgery. Method of measurement: Recording administered medications in the anesthesia record.;Patient satisfaction with the treatment method. Timepoint: In the recovery room or before discharge. Method of measurement: Questioning the patient using a questionnaire or Likert scale (e.g., from 1: Dissatisfied to 5: Completely satisfied). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBibimona Razavi
Bandare-abbas University of Medical Sciences
Outcome results
None listed