Effects of Sedation on Spinal Anesthesia-induced Maternal Hypotension
- Conditions
- Cesarean SectionPreoperative AnxietySpinal AnesthesiaSedationMaternal Hypotension
- Interventions
- Drug: Sedation
- Registration Number
- NCT02732197
- Lead Sponsor
- Van Training and Research Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 102
- 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
- Preoperative prehydration
- Placenta previa
- Placenta accreta
- Hypertension
- Pregnancy-induced hypertension
- Urgent category ≥2
- General anesthesia
- Spinal anesthesia with sedation other than thiopental sodium
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No sedation (NS) No sedation Parturients who did not receive any sedative agent after the spinal anesthesia performance. Sedation (S) 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.).
- Primary Outcome Measures
Name Time Method Maximum systolic arterial pressure (SAP) reductions from the baseline values 0-10 minutes % SAP reduction after spinal anesthesia
- Secondary Outcome Measures
Name Time Method Newborn Apgar score 1st min 1st min Apgar score at 1st min (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)
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
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
Atropine requirement 0-30 minutes Bolus of IV 0.5 mg atropine was given if bradycardia (HR \<55 beats min-1) occurred
Newborn Apgar score 5th min 5th min Apgar score at 5th min (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)
Trial Locations
- Locations (1)
Van Training and Research Hospital, Department of Anesthesiology
🇹🇷Van, Turkey