Clinical trial NCT02732197: Effects of Sedation on Spinal Anesthesia-induced Maternal Hypotension
Official title: Effects of Sedation on Spinal Anesthesia-induced Maternal Hypotension in Preoperatively Anxious Parturients Undergoing Urgent Category-1 Cesarean Section: A Historical Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Preoperative Anxiety
Spinal Anesthesia
Sedation
Maternal Hypotension
Lead sponsor: Van Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-04-08
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients undergoing urgent category-1 Cesarean section (C/S) under spinal anesthesia

Brief summary: Background: This study was designed to investigate the effect of sedation on the occurrence of maternal hypotension in preoperatively anxious parturients undergoing urgent category-1 Cesarean section (C/S) under spinal anesthesia.

Methods: After institutional ethics committee approval, prospectively collected data of 1824 parturients undergoing C/S were reviewed. Parturients with high preoperative anxiety scores (visual analogue scale for anxiety (VAS-A)≥70) undergoing C/S under spinal anesthesia with thiopental (Group S=49) and without any other type of sedation (Group NS=53) were included in the analysis. Hemodynamic parameters were documented and maximum systolic arterial pressure (SAP) reductions from the baseline after spinal anesthesia were calculated. Incidences of hypotension (SAP≥30% decrease from baseline or \<100 mmHg) and bradycardia (HR\<55 beats/min), and related-ephedrine and -atropine requirements were noted. Our primary endpoint was to compare the maximum SAP reductions from the baseline values in Groups S and NS. Secondary endpoints were incidences of hypotension and bradycardia, required ephedrine and atropine doses, newborn Apgar scores at 1st and 5th min.

Detailed description: Background: This study was designed to investigate the effect of thiopental sodium sedation on the occurrence of maternal hypotension in preoperatively anxious parturients undergoing urgent category-1 Cesarean section (C/S) under spinal anesthesia.

Methods: After institutional ethics committee approval, prospectively collected data of 1824 parturients undergoing C/S at Van Training and Research Hospital between August 2014 and February 2015 were reviewed. Parturients with high preoperative anxiety scores (visual analogue scale for anxiety (VAS-A)≥70) undergoing C/S under spinal anesthesia with thiopental (Group S=49) and without any other type of sedation (Group NS=53) were included in the analysis. All parturients received SA with hyperbaric bupivacaine 0.5% 2.5 mL. Hemodynamic parameters were documented and maximum systolic arterial pressure (SAP) reductions from the baseline after spinal anesthesia were calculated. Incidences of hypotension (SAP≥30% decrease from baseline or \<100 mmHg) and bradycardia (HR\<55 beats/min), and related-ephedrine and -atropine requirements were noted. All data were obtained from the surgical database and patient charts. Primary endpoint of our study was to compare the maximum SAP reductions from the baseline values in Groups S and NS. Secondary endpoints were incidences of hypotension and bradycardia, required ephedrine and atropine doses, newborn Apgar scores at 1st and 5th min.

Eligibility criteria: Inclusion Criteria:

* Urgent category-1 C/S
* ASA physical status I-II
* Aged between 18 and 35 years
* Term (≥37 weeks) singleton pregnancy
* BMI \<40 kg/m2
* Height \>150 cm or \<180 cm
* High preoperative anxiety scores (visual analogue scale for anxiety (VAS-A) ≥70)
* Spinal anesthesia with thiopental sodium sedation
* Spinal anesthesia without any sedation

Exclusion Criteria:

* Preoperative prehydration
* Placenta previa
* Placenta accreta
* Hypertension
* Pregnancy-induced hypertension
* Urgent category ≥2
* General anesthesia
* Spinal anesthesia with sedation other than thiopental sodium

Primary outcomes:
measure: Maximum systolic arterial pressure (SAP) reductions from the baseline values
timeFrame: 0-10 minutes
Secondary outcomes:
measure: Incidence of maternal hypotension
timeFrame: 0-30 minutes
measure: Incidence of maternal bradycardia
timeFrame: 0-30 minutes
measure: Ephedrine requirement
timeFrame: 0-30 minutes
measure: Atropine requirement
timeFrame: 0-30 minutes
measure: Incidence of maternal nausea
timeFrame: 0-30 minutes
measure: Incidence of maternal vomiting
timeFrame: 0-30 minutes
measure: Newborn Apgar score 1st min
timeFrame: 1st min
measure: Newborn Apgar score 5th min
timeFrame: 5th min
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Training and Research Hospital, Department of Anesthesiology
Study officials:
affiliation: Design and conduct the study, review and analyze the data, and write the manuscript
name: Cenk Sahan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orbach-Zinger S, Ginosar Y, Elliston J, Fadon C, Abu-Lil M, Raz A, Goshen-Gottstein Y, Eidelman LA. Influence of preoperative anxiety on hypotension after spinal anaesthesia in women undergoing Caesarean delivery. Br J Anaesth. 2012 Dec;109(6):943-9. doi: 10.1093/bja/aes313. Epub 2012 Sep 10.