Effects of Sedation on Spinal Anesthesia-induced Maternal Hypotension
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sedation (S) 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: 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.).
Other Names:
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| No sedation (NS) Parturients who did not receive any sedative agent after the spinal anesthesia performance. |
Drug: No sedation
Parturients did not receive any type of sedation after spinal anesthesia.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Maximum systolic arterial pressure (SAP) reductions from the baseline values [0-10 minutes]
% SAP reduction after spinal anesthesia
Secondary Outcome Measures
- Incidence of maternal hypotension [0-30 minutes]
Incidence of hypotension during the surgery (decrease in SAP >30% from baseline or an absolute value <100 mmHg)
- Incidence of maternal bradycardia [0-30 minutes]
Incidence of bradycardia during the surgery (heart rate (HR) <55 beats min-1)
- Ephedrine requirement [0-30 minutes]
Ephedrine 5 mg IV boluses were administered with 2 min intervals until SAP returned to a value of >100 mmHg
- Atropine requirement [0-30 minutes]
Bolus of IV 0.5 mg atropine was given if bradycardia (HR <55 beats min-1) occurred
- Incidence of maternal nausea [0-30 minutes]
If any during the Cesarean section, recorded
- Incidence of maternal vomiting [0-30 minutes]
If any during the Cesarean section, recorded
- Newborn Apgar score 1st min [1st min]
Apgar score at 1st min (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)
- Newborn Apgar score 5th min [5th min]
Apgar score at 5th min (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Urgent category-1 C/S
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ASA physical status I-II
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Aged between 18 and 35 years
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Term (≥37 weeks) singleton pregnancy
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BMI <40 kg/m2
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Height >150 cm or <180 cm
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High preoperative anxiety scores (visual analogue scale for anxiety (VAS-A) ≥70)
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Spinal anesthesia with thiopental sodium sedation
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Spinal anesthesia without any sedation
Exclusion Criteria:
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Preoperative prehydration
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Placenta previa
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Placenta accreta
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Hypertension
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Pregnancy-induced hypertension
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Urgent category ≥2
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General anesthesia
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Spinal anesthesia with sedation other than thiopental sodium
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Van Training and Research Hospital, Department of Anesthesiology | Van | Turkey |
Sponsors and Collaborators
- Van Training and Research Hospital
Investigators
- Principal Investigator: Cenk Sahan, MD, Design and conduct the study, review and analyze the data, and write the manuscript
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015/4