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Effects of Sedation on Spinal Anesthesia-induced Maternal Hypotension

NCT02732197 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2016-04-11

No results posted yet for this study

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.

Conditions

  • Cesarean Section
  • Preoperative Anxiety
  • Spinal Anesthesia
  • Sedation
  • Maternal Hypotension

Interventions

DRUG

Sedation

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.).

DRUG

No sedation

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

Sponsors & Collaborators

  • Van Training and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Cenk Sahan, MD · Design and conduct the study, review and analyze the data, and write the manuscript

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02732197 on ClinicalTrials.gov