Cesarean SectionNCT02732197
Effects of Sedation on Spinal Anesthesia-induced Maternal Hypotension
An observational study of Cesarean Section and Preoperative Anxiety, run by Van Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Preoperative Anxiety, Spinal Anesthesia
- What is being tested?
- Sedation and No sedation
- Type of treatment
- Injection or infusion
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Parturients undergoing urgent category-1 Cesarean section (C/S) under spinal anesthesia
Who may be able to join
- 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
Show all 9Show fewer
- High preoperative anxiety scores (visual analogue scale for anxiety (VAS-A) ≥70)
- Spinal anesthesia with thiopental sodium sedation
- Spinal anesthesia without any sedation
Who cannot join
- Preoperative prehydration
- Placenta previa
- Placenta accreta
- Hypertension
- Pregnancy-induced hypertension
- Urgent category ≥2
- General anesthesia
- Spinal anesthesia with sedation other than thiopental sodium
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Training and Research Hospital, Department of Anesthesiology
Van
About this study
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
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.
Read the 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.
- Being tested
- Sedation, No sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedationDrug
Also called Thiopental
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 sedationDrug
Also called No drug
Parturients did not receive any type of sedation after spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 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.). Receives: Drug: Sedation | |
| No sedation (NS) | Parturients who did not receive any sedative agent after the spinal anesthesia performance. Receives: Drug: No sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum systolic arterial pressure (SAP) reductions from the baseline values
% SAP reduction after spinal anesthesia
Measured: 0-10 minutes
Secondary outcomes (8)
Incidence of maternal hypotension
Incidence of hypotension during the surgery (decrease in SAP >30% from baseline or an absolute value <100 mmHg)
Measured: 0-30 minutes
Incidence of maternal bradycardia
Incidence of bradycardia during the surgery (heart rate (HR) <55 beats min-1)
Measured: 0-30 minutes
Ephedrine requirement
Ephedrine 5 mg IV boluses were administered with 2 min intervals until SAP returned to a value of >100 mmHg
Measured: 0-30 minutes
Atropine requirement
Bolus of IV 0.5 mg atropine was given if bradycardia (HR <55 beats min-1) occurred
Measured: 0-30 minutes
Incidence of maternal nausea
If any during the Cesarean section, recorded
Measured: 0-30 minutes
Incidence of maternal vomiting
If any during the Cesarean section, recorded
Measured: 0-30 minutes
Newborn Apgar score 1st min
Apgar score at 1st min (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)
Measured: 1st min
Newborn Apgar score 5th min
Apgar score at 5th min (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)
Measured: 5th min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Van Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr.Cenk Sahan, Van Training and Research Hospital
- Investigators
- Cenk Sahan, MD, Principal investigator, Design and conduct the study, review and analyze the data, and write the manuscript
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732197
- Sponsor's protocol ID
- 2015/4
- Status last verified
- Apr 2016
- First submitted
- 4 Apr 2016
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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: 10.1093/bja/aes313. Epub 2012 Sep 10.
PubMed 22964265
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02732197
- Acronym / sponsor ID
- 2015/4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Van Training and Research HospitalOther government
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation (S) | – | Drug: SedationParturients 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 (NS) | – | Drug: No sedationParturients who did not receive any sedative agent after the spinal anesthesia performance. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Parturients undergoing urgent category-1 Cesarean section (C/S) under spinal anesthesia
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- Preoperative prehydration
- Placenta previa
- Placenta accreta
- Hypertension
- Pregnancy-induced hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SedationAlso: ThiopentalParturients 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 (S) |
| No sedationAlso: No drugParturients did not receive any type of sedation after spinal anesthesia. | Drug | No sedation (NS) |
Primary outcome
Maximum systolic arterial pressure (SAP) reductions from the baseline values
Time frame: 0-10 minutes
% SAP reduction after spinal anesthesia
8 secondary outcomes
Incidence of maternal hypotension
Time frame: 0-30 minutes
Incidence of maternal bradycardia
Time frame: 0-30 minutes
Ephedrine requirement
Time frame: 0-30 minutes
Atropine requirement
Time frame: 0-30 minutes
Incidence of maternal nausea
Time frame: 0-30 minutes
Incidence of maternal vomiting
Time frame: 0-30 minutes
Newborn Apgar score 1st min
Time frame: 1st min
Newborn Apgar score 5th min
Time frame: 5th min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Results publication: PubMed 22964265Orbach-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: 10.1093/bja/aes313. Epub 2012 Sep 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cenk Sahan, MD principal investigator
Design and conduct the study, review and analyze the data, and write the manuscript
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section and Preoperative Anxiety, run by Van Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum systolic arterial pressure (SAP) reductions from the baseline values (time frame: 0-10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02732197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2016.