Effects of Sedation on Spinal Anesthesia-induced Maternal Hypotension

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732197
• Other study ID #: 2015/4
• Status: Completed
• Phase: N/A
• First received: April 4, 2016
• Last updated: April 8, 2016
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: April 2016
• Source: Van Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

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.).
• No sedation
Parturients did not receive any type of sedation after spinal anesthesia.

Locations

Country	Name	City	State
Turkey	Van Training and Research Hospital, Department of Anesthesiology	Van

Sponsors (1)

Lead Sponsor	Collaborator
Van Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Orbach-Zinger S, Ginosar Y, Elliston J, Fadon C, Abu-Lil M, Raz A, Goshen-Gottstein Y, Eidelman LA. Influence of preoperative anxiety on hypotension after spinal anaesthesia in women undergoing Caesarean delivery. Br J Anaesth. 2012 Dec;109(6):943-9. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum systolic arterial pressure (SAP) reductions from the baseline values	% SAP reduction after spinal anesthesia	0-10 minutes	Yes
Secondary	Incidence of maternal hypotension	Incidence of hypotension during the surgery (decrease in SAP >30% from baseline or an absolute value <100 mmHg)	0-30 minutes	Yes
Secondary	Incidence of maternal bradycardia	Incidence of bradycardia during the surgery (heart rate (HR) <55 beats min-1)	0-30 minutes	Yes
Secondary	Ephedrine requirement	Ephedrine 5 mg IV boluses were administered with 2 min intervals until SAP returned to a value of >100 mmHg	0-30 minutes	Yes
Secondary	Atropine requirement	Bolus of IV 0.5 mg atropine was given if bradycardia (HR <55 beats min-1) occurred	0-30 minutes	Yes
Secondary	Incidence of maternal nausea	If any during the Cesarean section, recorded	0-30 minutes	Yes
Secondary	Incidence of maternal vomiting	If any during the Cesarean section, recorded	0-30 minutes	Yes
Secondary	Newborn Apgar score 1st min	Apgar score at 1st min (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)	1st min	Yes
Secondary	Newborn Apgar score 5th min	Apgar score at 5th min (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)	5th min	Yes