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NCT Number: NCT02732197

Effects of Sedation on Spinal Anesthesia-induced Maternal Hypotension

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.

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Key information

Conditions

Cesarean Section Maternal Hypotension Preoperative Anxiety Sedation Spinal Anesthesia

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Van Training and Research Hospital, Department of Anesthesiology

Van, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sedation

Drug

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.).

Other names: Thiopental

No sedation

Drug

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

Other names: No drug

Primary outcomes

  1. Maximum systolic arterial pressure (SAP) reductions from the baseline values

    Time frame: 0-10 minutes

    % SAP reduction after spinal anesthesia

Secondary outcomes

  1. Incidence of maternal hypotension

    Time frame: 0-30 minutes

    Incidence of hypotension during the surgery (decrease in SAP >30% from baseline or an absolute value <100 mmHg)

  2. Incidence of maternal bradycardia

    Time frame: 0-30 minutes

    Incidence of bradycardia during the surgery (heart rate (HR) <55 beats min-1)

  3. Ephedrine requirement

    Time frame: 0-30 minutes

    Ephedrine 5 mg IV boluses were administered with 2 min intervals until SAP returned to a value of >100 mmHg

  4. Atropine requirement

    Time frame: 0-30 minutes

    Bolus of IV 0.5 mg atropine was given if bradycardia (HR <55 beats min-1) occurred

  5. Incidence of maternal nausea

    Time frame: 0-30 minutes

    If any during the Cesarean section, recorded

  6. Incidence of maternal vomiting

    Time frame: 0-30 minutes

    If any during the Cesarean section, recorded

  7. Newborn Apgar score 1st min

    Time frame: 1st min

    Apgar score at 1st min (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)

  8. Newborn Apgar score 5th min

    Time frame: 5th min

    Apgar score at 5th min (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)

Sponsors and collaborators

Lead sponsor

Van Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 8, 2016
Registry last updated
Apr 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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