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Effects of Sedation on Spinal Anesthesia-induced Maternal Hypotension

Effects of Sedation on Spinal Anesthesia-induced Maternal Hypotension in Preoperatively Anxious Parturients Undergoing Urgent Category-1 Cesarean Section: A Historical Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02732197
Enrollment
102
Registered
2016-04-08
Start date
2014-08-31
Completion date
2015-02-28
Last updated
2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Maternal Hypotension, Preoperative Anxiety, Sedation, 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.

Interventions

DRUGSedation

Parturients who received IV thiopental 2 mg kg-1 and if necessary additional 50 mg immediately after spinal anesthesia until reaching at least Ramsay sedation score of 3 (1: patient anxious, agitated or restless, 6: patient with no response to light glabella tap or loud auditory stimulus.).

Parturients did not receive any type of sedation after spinal anesthesia.

Sponsors

Van Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Maximum systolic arterial pressure (SAP) reductions from the baseline values0-10 minutes% SAP reduction after spinal anesthesia

Secondary

MeasureTime frameDescription
Incidence of maternal bradycardia0-30 minutesIncidence of bradycardia during the surgery (heart rate (HR) \<55 beats min-1)
Ephedrine requirement0-30 minutesEphedrine 5 mg IV boluses were administered with 2 min intervals until SAP returned to a value of \>100 mmHg
Atropine requirement0-30 minutesBolus of IV 0.5 mg atropine was given if bradycardia (HR \<55 beats min-1) occurred
Incidence of maternal hypotension0-30 minutesIncidence of hypotension during the surgery (decrease in SAP \>30% from baseline or an absolute value \<100 mmHg)
Incidence of maternal vomiting0-30 minutesIf any during the Cesarean section, recorded
Newborn Apgar score 1st min1st minApgar score at 1st min (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)
Newborn Apgar score 5th min5th minApgar score at 5th min (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)
Incidence of maternal nausea0-30 minutesIf any during the Cesarean section, recorded

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026