Clinical trial NCT04186091: Perfusion Index Predicts Post-spinal Hypotension in Obese Parturients for Cesarean Section
Official title: Perfusion Index Predicts Post-spinal Hypotension in Obese Parturients for Cesarean Section-A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perfusion Index Predicts Post-spinal Hypotension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: After approval of ethical committee and written informed consent, fifty Parturients aged between 18- 40 years, ASA I and II with term singleton pregnancies with BMI between 25 \&40 admitted for cesarean section under spinal anesthesia were recruited in this prospective, observational study. The primary outcome is the correlation between baseline perfusion index and post spinal hypotension. The secondary outcome is the correlation between BMI and the incidence of hypotension after spinal anesthesia. Heart rate, blood pressure, perfusion index before and after spinal induction using Masimo device, level of sensory block, dose of ephedrine required to correct hypotension, dose of atropine required to correct bradycardia, incidence of nausea, vomiting and shivering were recorded.

Brief summary: Hypotension is a common adverse effect of spinal anesthesia during caesarean section especially in obese patients.

The aim of this study is to find out the correlation between baseline PI and post spinal hypotension in obese parturient.

Detailed description: Abstract Background Hypotension is a common adverse effect of spinal anesthesia during caesarean section especially in obese patients.

The aim of this study is to find out the correlation between baseline PI and post spinal hypotension in obese parturient.

Methods After approval of ethical committee and written informed consent, fifty Parturients aged between 18- 40 years, ASA I and II with term singleton pregnancies with BMI between 25 \&40 admitted for cesarean section under spinal anesthesia were recruited in this prospective, observational study. The primary outcome is the correlation between baseline perfusion index and post spinal hypotension. The secondary outcome is the correlation between BMI and the incidence of hypotension after spinal anesthesia. Heart rate, blood pressure, perfusion index before and after spinal induction using Masimo device, level of sensory block, dose of ephedrine required to correct hypotension, dose of atropine required to correct bradycardia, incidence of nausea, vomiting and shivering were recorded.

Eligibility criteria: Inclusion Criteria:

* Fifty parturient
* Aged between 18- 40,
* ASA I and II
* With term singleton pregnancies
* With 25 ≥ BMI≤ 40
* Conducted for cesarean section under spinal anesthesia

Exclusion Criteria:

* Emergency cases,
* Placenta previa,
* Preeclampsia,
* Cardiovascular and cerebrovascular diseases,
* Patient with contraindication for regional anesthesia
* Patient with peripheral vascular diseases as DVT.

Primary outcomes:
measure: correlation between baseline perfusion index and post spinal decrease in systolic blood pressure
timeFrame: 24 hours Postoperative
Secondary outcomes:
measure: correlation between BMI and the incidence of post-spinal hypotension
timeFrame: 24 hours Postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abdalla Mohamed
Study officials:
affiliation: Cairo University
name: Ahmed Abdalla Mohamed, M.D
role: STUDY_DIRECTOR
References: