Cesarean SectionCSEAFCSWPPAVNCT03497364
Combined Spinal-epidural Anesthesia for Cesarean Section Without Prophylactical Prehydration and Vasopressors
A study testing bupivacaine and ropivacaine in people with Cesarean Section and Anesthesia, Spinal, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
Hypotension is a common complication in pregnant women after spinal anesthesia and related with the dose of local anesthetic. Injecting small dose local anesthetic into subarachnoid space can decrease the incidence of hypotension, but increase the risk of incomplete analgesia and muscle relaxation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section, Anesthesia, Spinal
- What is being tested?
- bupivacaine and ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 930 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 30 Nov 2021
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women who were scheduled for cesarean section.
Who cannot join
- Women with cardiovascular disease, fetal abnormalities, placental abruption, placenta previa, placental abnormalities, sidewall placenta, abnormal fetal heart rate and spinal anesthesia contraindications.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ShenZhen People's Hospital of Jinan University
Shenzhen, Guangdong, 518020
Bowan Huang, doctor, +86 755-25533018, 285021731@qq.com
About this study
Official title: Improving Combined Spinal-epidural Anesthesia for Decreasing Hypotension in Pregnant Women Without Prophylactical Prehydration and Vasopressors
Hypotension is a common complication in pregnant women after spinal anesthesia and related with the dose of local anesthetic. Injecting small dose local anesthetic into subarachnoid space can decrease the incidence of hypotension, but increase the risk of incomplete analgesia and muscle relaxation. The investigators hypothesize there is an optimal dose of bupivacaine and ropivacaine for subarachnoid injection in pregnant women, which can cause enough anesthesia and obviously decrease the incidence of hypotension without prophylactical prehydration and vasopressors. To verify this hypothesis, full-term pregnant women who were scheduled for elective cesarean section were recruited.Combined spinal-epidural anesthesia was performed for pregnant women after written informed consents. The dose of bupivacaine or ropivacaine is small and depends on height of pregnant women. The blood pressure, heart rate, respiratory rate, SpO2 and fetal heart rate were recorded and the blood flow volume of uterine artery was monitored The sensory and motor block were evaluated. After delivery, umbilical blood samples were taken for blood gas analysis. APGAR scores and neurological behavior of infant were evaluated and recorded. In the intraoperative period, side-effects and requirement for sedation, epidural injection or general anesthesia were noted. The quality of anaesthesia (judged by the anaesthetist), the quality of muscle relaxation (judged by the surgeon) and the degree of intraoperative comfort (judged by the patient) were recorded as excellent, good, fair or poor.
Read the detailed description
- General: This was a single-centre randomized controlled trial performed at ShenZhen People's Hospital of Jinan University. Study protocol was approval was by the Ethics Committee of ShenZhen People's Hospital of Jinan University, ShenZhen, China (Permit No. SZY-00251, Chairperson Prof. Xiaofang Yu) on 8 February 2017. Pregnant women who were scheduled for cesarean section were recruited. Written informed consents were obtained from all patients. Women with cardiovascular disease, fetal abnormalities, placental abruption, placenta previa, placental abnormalities, sidewall placenta, abnormal fetal heart rate and spinal anesthesia contraindications were excluded from the study.
- Sample Size Calculation: SBP < 90 mmHg or 70% of the baseline value is defined as hypotension; in the study by Langesaeter et al in Anesthesiology magazine, the incidence of hypotension was 20% with prophylactic phenylephrine, and we considered a ≤ 8% difference in the incidence of hypotension to be of clinical significance. Assuming a type I error protection of 0.05 and a power of 0.80, the sample size for a non-inferiority test (margin Δ=0.08) was estimated using the normal approximation to the binomial distribution. Therefore, each group requires 310 subjects.
- Anesthesia: Women were randomly divided into three groups, Bupivacaine group, Ropivacaine group and Control group. After entering the operation room, patients were placed supine with left lateral tilt and blood pressure was measured three times at 1-min intervals. The arithmetic average of the three measured values was regarded as the basal pressure of pregnant women. Next, electrocardiogram and pulse oximetry were also monitored. Supplementary oxygen was given through a facemask. Venipuncture was performed in the forearm vein. In Bupivacaine and Ropivacaine group, 500 ml Ringer's lactate was slow given for subjects before anesthesia without prehydration. In Control group, 1000 ml hydroxyethylstarch (6%) was first infused for subjects in the ward, after that 500 ml Ringer's lactate was slow given for subjects before anesthesia. Then, with the subjects in left lateral position, combined spinal-epidural anesthesia was performed as follows: skin was infiltrated by lidocaine at the L3-4 or L4-5 interspace; epidural puncture needle was slowly perpendicularly advanced until the tip passed through the ligamentum flavum and reached to epidural space, which was verified with the loss-of-resistance; then intrathecal injection was carried out by spinal needle of 25G, and the epidural catheter was inserted 4-6 cm. Subjects were then immediately recovered in supine with left lateral tilt. In Bupivacaine group, 0.5 % bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection. The dose of bupivacaine depended on height of subjects (1.7 ml for 173~174cm, 1.65 ml for 170~172cm, 1.6 ml for 168~169cm, 1.55 ml for 165~167cm, 1.5 ml for 163~164cm, 1.45 ml for 160~162cm, 1.4 ml for 158~159cm, 1.35 ml for 155~157cm, 1.3 ml for 153~154cm, 1.25 ml for 150~152cm, 1.2 ml for 148~149cm)，1.15 ml for 145~147cm). In Ropivacaine group, 0.5 % ropivacaine (1% ropivacaine (1.5 ml) + cerebrospinal fluid (1.5 ml)) was injection. The dose of ropivacaine depended on height of subjects (2.3 ml for 173~174cm, 2.2 ml for 170~172cm, 2.1ml for 168~169cm, 2.0 ml for 165~167cm, 1.9 ml for 163~164cm, 1.8 ml for 160~162cm, 1.7 ml for 158~159cm, 1.6 ml for 155~157cm, 1.5 ml for 153~154cm, 1.4 ml for 150~152cm, 1.3 ml for 148~149cm, 1.2 ml for 145~147cm). In Control group, 2ml bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection for all subjects. Immediately after intrathecal injection, in control group, phenylephrine was introduced by continuous infusion pumps programmed for an infusion rate of 0.25 ug.kg-1.min-1 to maintain systolic blood pressure at ≥ 90 mmHg or 70% -100 % of baseline value. In Bupivacaine and Ropivacaine group, no prophylactic phenylephrine was introduced For all subjects, when systolic blood pressure was less than 90 mmHg or 70% of baseline value. 100 ug phenylephrine was given and repeated every 1 min until the systolic blood pressure returned to normal. When heart rate was less than 60 beat/min. 0.5-1mg atropine was given to maintain normal heart rate. Nausea and vomiting were treated with metoclopramide 10 mg i.v. Sensory block level after intrathecal injection was assessed with a 20G hypodermic needle (no sensation to pinprick). When the maximum sensory block height was lower than T8, epidural injection of 2% lidocaine (3ml/5min, total volume was less than 15 ml) was given or anesthetic technique was changed into general anesthesia.
- Data acquisition: After intrathecal injection, the blood pressure, heart rate, respiratory rate, SpO2 and fetal heart rate were recorded every 1 min until fetal delivery and then were recorded every 3 min until the end of surgery. The blood flow volume of uterine artery was monitored by ultrasound. The level of sensory block, defined as the loss of pin-prick sensation (20G hypodermic needle) at midclavicular level, was measured every 1 min until it reached the T8 dermatome level and then every 10 min during surgery. The following variables were recorded: time to initial onset of analgesia, time for sensory block to reach the T8 dermatome level, time for sensory block to reach maximum dermatome level, time to two-segment regression of analgesic level, and regression of analgesic level to the S2 dermatome. Anesthesia was considered adequate for surgery if pain sensation was lost at the T8 level. Motor block was assessed every 1 min using the Bromage scale (0 = no motor block, 3 = complete motor block of lower limbs) until complete motor block and then every 30 min until the return of normal motor function. The times to complete motor block and complete recovery were recorded. The motor block score when the sensory block level reached T8 was also recorded. The time from anesthesia initiation to delivery, time from skin incision to delivery and time from uterus incision to delivery were recorded. The total dose of phenylephrine and total volume of fluid before delivery were recorded. After delivery, umbilical blood samples were taken for blood gas analysis. APGAR scores at 1 and 5 min were evaluated and recorded. In the intraoperative period, side-effects and requirement for sedation, epidural injection or general anesthesia were noted. Neurologic assessment (muscle force, muscle tone, sucking reflex, rooting reflex, moro reflex and grasp reflex) of the infant was carried out at 2h,4h,8h, 1d,2d,3d,4d and 7d after delivery. The quality of anaesthesia (judged by the anaesthetist), the quality of muscle relaxation (judged by the surgeon) and the degree of intraoperative comfort (judged by the patient) were recorded as excellent, good, fair or poor.
- Statistical Analysis: Statistical analysis was performed using SPSS 13.0 software package. All metering data were recorded as mean ± standard deviation and Independent-Samples T test or One-way ANOVA was used to compare the metering data. Chi-square test was used to compare the enumeration data. p<0.05 indicates that the differences have statistical significance.
- Conditions
- Cesarean Section, Anesthesia, Spinal
- Being tested
- bupivacaine, ropivacaine
- Keywords
- Cesarean Section, Hypotension, Combined spinal-epidural anesthesia
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaineDrug
0.5 % bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection according to the height of subjects (1.7 ml for 173~174cm, 1.65 ml for 170~172cm, 1.6 ml for 168~169cm, 1.55 ml for 165~167cm, 1.5 ml for 163~164cm, 1.45 ml for 160~162cm, 1.4 ml for 158~159cm, 1.35 ml for 155~157cm, 1.3 ml for 153~154cm, 1.25 ml for 150~152cm, 1.2 ml for 148~149cm)，1.15 ml for 145~147cm).
ropivacaineDrug
0.5 % ropivacaine (1% ropivacaine (1.5 ml) + cerebrospinal fluid (1.5 ml)) was injection according to the height of subjects (2.300 ml for 173~174cm, 2.225 ml for 170~172cm, 2.15 0ml for 168~169cm, 2.075 ml for 165~167cm, 2.000 ml for 163~164cm, 1.925 ml for 160~162cm, 1.850 ml for 158~159cm, 1.775 ml for 155~157cm, 1.700 ml for 153~154cm, 1.625 ml for 150~152cm, 1.55 0ml for 148~149cm, 1.475 ml for 145~147cm)
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine group | Experimental | Pregnant women received combined spinal-epidural anesthesia by injecting bupivacaine. The dose of bupivacaine depended on height of subjects. Receives: Drug: bupivacaine |
| Ropivacaine group | Experimental | Pregnant women received combined spinal-epidural anesthesia by injecting ropivacaine. The dose of ropivacaine depended on height of subjects). Receives: Drug: ropivacaine |
| Control group | No intervention | Pregnant women received combined spinal-epidural anesthesia by injecting bupivacaine. 2ml bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection for all subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension after anesthesia
Hypotension after anesthesia expressed in number of patients with one or more episodes of hypotension (Systolic blood pressure < 90 mmHg or 70% of baseline value) up to fetal delivery.
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start1 May 2018
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 930 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhongjun Zhang, master, Study director, ShenZhen People's Hospital of Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497364
- Sponsor's protocol ID
- SZY-00251
- Acronym
- CSEAFCSWPPAV
- Status last verified
- Nov 2020
- First submitted
- 22 Mar 2018
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang J, Wen G, Huang Q, Huang B. Anesthesia characteristic of an algorithm of bupivacaine dose based on height in caesarean section under spinal anesthesia: a retrospective cohort study. BMC Anesthesiol. 2023 May 2;23(1):146. doi: 10.1186/s12871-023-02113-0.
PubMed 37131191Huang Q, Wen G, Hai C, Zheng Z, Li Y, Huang Z, Huang B. A Height-Based Dosing Algorithm of Bupivacaine in Spinal Anesthesia for Decreasing Maternal Hypotension in Cesarean Section Without Prophylactic Fluid Preloading and Vasopressors: A Randomized-Controlled Non-Inferiority Trial. Front Med (Lausanne). 2022 Jun 10;9:858115. doi: 10.3389/fmed.2022.858115. eCollection 2022.
PubMed 35755061Huang B, Huang Q, Hai C, Zheng Z, Li Y, Zhang Z. Height-based dosing algorithm of bupivacaine in spinal anaesthesia for decreasing maternal hypotension in caesarean section without prophylactic fluid preloading and vasopressors: study protocol for a randomised controlled non-inferiority trial. BMJ Open. 2019 May 16;9(5):e024912. doi: 10.1136/bmjopen-2018-024912.
PubMed 31101694
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Combined Spinal-epidural Anesthesia for Decreasing Hypotension in Pregnant Women Without Prophylactical Prehydration and Vasopressors
- ClinicalTrials.gov ID
- NCT03497364
- Acronym / sponsor ID
- CSEAFCSWPPAV / SZY-00251
- Conditions
- Cesarean Section, Anesthesia, Spinal
- Keywords
- Cesarean Section, Hypotension, Combined spinal-epidural anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 930 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 13 Apr 2018 (actual)
- 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.
Hypotension is a common complication in pregnant women after spinal anesthesia and related with the dose of local anesthetic. Injecting small dose local anesthetic into subarachnoid space can decrease the incidence of hypotension, but increase the risk of incomplete analgesia and muscle relaxation. The investigators hypothesize there is an optimal dose of bupivacaine and ropivacaine for subarachnoid injection in pregnant women, which can cause enough anesthesia and obviously decrease the incidence of hypotension without prophylactical prehydration and vasopressors. To verify this hypothesis, full-term pregnant women who were scheduled for elective cesarean section were recruited.Combined spinal-epidural anesthesia was performed for pregnant women after written informed consents. The dose of bupivacaine or ropivacaine is small and depends on height of pregnant women. The blood pressure, heart rate, respiratory rate, SpO2 and fetal heart rate were recorded and the blood flow volume of uterine artery was monitored The sensory and motor block were evaluated. After delivery, umbilical blood samples were taken for blood gas analysis. APGAR scores and neurological behavior of infant were evaluated and recorded. In the intraoperative period, side-effects and requirement for sedation, epidural injection or general anesthesia were noted. The quality of anaesthesia (judged by the anaesthetist), the quality of muscle relaxation (judged by the surgeon) and the degree of intraoperative comfort (judged by the patient) were recorded as excellent, good, fair or poor.
Detailed description
- General: This was a single-centre randomized controlled trial performed at ShenZhen People's Hospital of Jinan University. Study protocol was approval was by the Ethics Committee of ShenZhen People's Hospital of Jinan University, ShenZhen, China (Permit No. SZY-00251, Chairperson Prof. Xiaofang Yu) on 8 February 2017. Pregnant women who were scheduled for cesarean section were recruited. Written informed consents were obtained from all patients. Women with cardiovascular disease, fetal abnormalities, placental abruption, placenta previa, placental abnormalities, sidewall placenta, abnormal fetal heart rate and spinal anesthesia contraindications were excluded from the study.
- Sample Size Calculation: SBP < 90 mmHg or 70% of the baseline value is defined as hypotension; in the study by Langesaeter et al in Anesthesiology magazine, the incidence of hypotension was 20% with prophylactic phenylephrine, and we considered a ≤ 8% difference in the incidence of hypotension to be of clinical significance. Assuming a type I error protection of 0.05 and a power of 0.80, the sample size for a non-inferiority test (margin Δ=0.08) was estimated using the normal approximation to the binomial distribution. Therefore, each group requires 310 subjects.
- Anesthesia: Women were randomly divided into three groups, Bupivacaine group, Ropivacaine group and Control group. After entering the operation room, patients were placed supine with left lateral tilt and blood pressure was measured three times at 1-min intervals. The arithmetic average of the three measured values was regarded as the basal pressure of pregnant women. Next, electrocardiogram and pulse oximetry were also monitored. Supplementary oxygen was given through a facemask. Venipuncture was performed in the forearm vein. In Bupivacaine and Ropivacaine group, 500 ml Ringer's lactate was slow given for subjects before anesthesia without prehydration. In Control group, 1000 ml hydroxyethylstarch (6%) was first infused for subjects in the ward, after that 500 ml Ringer's lactate was slow given for subjects before anesthesia. Then, with the subjects in left lateral position, combined spinal-epidural anesthesia was performed as follows: skin was infiltrated by lidocaine at the L3-4 or L4-5 interspace; epidural puncture needle was slowly perpendicularly advanced until the tip passed through the ligamentum flavum and reached to epidural space, which was verified with the loss-of-resistance; then intrathecal injection was carried out by spinal needle of 25G, and the epidural catheter was inserted 4-6 cm. Subjects were then immediately recovered in supine with left lateral tilt. In Bupivacaine group, 0.5 % bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection. The dose of bupivacaine depended on height of subjects (1.7 ml for 173~174cm, 1.65 ml for 170~172cm, 1.6 ml for 168~169cm, 1.55 ml for 165~167cm, 1.5 ml for 163~164cm, 1.45 ml for 160~162cm, 1.4 ml for 158~159cm, 1.35 ml for 155~157cm, 1.3 ml for 153~154cm, 1.25 ml for 150~152cm, 1.2 ml for 148~149cm)，1.15 ml for 145~147cm). In Ropivacaine group, 0.5 % ropivacaine (1% ropivacaine (1.5 ml) + cerebrospinal fluid (1.5 ml)) was injection. The dose of ropivacaine depended on height of subjects (2.3 ml for 173~174cm, 2.2 ml for 170~172cm, 2.1ml for 168~169cm, 2.0 ml for 165~167cm, 1.9 ml for 163~164cm, 1.8 ml for 160~162cm, 1.7 ml for 158~159cm, 1.6 ml for 155~157cm, 1.5 ml for 153~154cm, 1.4 ml for 150~152cm, 1.3 ml for 148~149cm, 1.2 ml for 145~147cm). In Control group, 2ml bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection for all subjects. Immediately after intrathecal injection, in control group, phenylephrine was introduced by continuous infusion pumps programmed for an infusion rate of 0.25 ug.kg-1.min-1 to maintain systolic blood pressure at ≥ 90 mmHg or 70% -100 % of baseline value. In Bupivacaine and Ropivacaine group, no prophylactic phenylephrine was introduced For all subjects, when systolic blood pressure was less than 90 mmHg or 70% of baseline value. 100 ug phenylephrine was given and repeated every 1 min until the systolic blood pressure returned to normal. When heart rate was less than 60 beat/min. 0.5-1mg atropine was given to maintain normal heart rate. Nausea and vomiting were treated with metoclopramide 10 mg i.v. Sensory block level after intrathecal injection was assessed with a 20G hypodermic needle (no sensation to pinprick). When the maximum sensory block height was lower than T8, epidural injection of 2% lidocaine (3ml/5min, total volume was less than 15 ml) was given or anesthetic technique was changed into general anesthesia.
- Data acquisition: After intrathecal injection, the blood pressure, heart rate, respiratory rate, SpO2 and fetal heart rate were recorded every 1 min until fetal delivery and then were recorded every 3 min until the end of surgery. The blood flow volume of uterine artery was monitored by ultrasound. The level of sensory block, defined as the loss of pin-prick sensation (20G hypodermic needle) at midclavicular level, was measured every 1 min until it reached the T8 dermatome level and then every 10 min during surgery. The following variables were recorded: time to initial onset of analgesia, time for sensory block to reach the T8 dermatome level, time for sensory block to reach maximum dermatome level, time to two-segment regression of analgesic level, and regression of analgesic level to the S2 dermatome. Anesthesia was considered adequate for surgery if pain sensation was lost at the T8 level. Motor block was assessed every 1 min using the Bromage scale (0 = no motor block, 3 = complete motor block of lower limbs) until complete motor block and then every 30 min until the return of normal motor function. The times to complete motor block and complete recovery were recorded. The motor block score when the sensory block level reached T8 was also recorded. The time from anesthesia initiation to delivery, time from skin incision to delivery and time from uterus incision to delivery were recorded. The total dose of phenylephrine and total volume of fluid before delivery were recorded. After delivery, umbilical blood samples were taken for blood gas analysis. APGAR scores at 1 and 5 min were evaluated and recorded. In the intraoperative period, side-effects and requirement for sedation, epidural injection or general anesthesia were noted. Neurologic assessment (muscle force, muscle tone, sucking reflex, rooting reflex, moro reflex and grasp reflex) of the infant was carried out at 2h,4h,8h, 1d,2d,3d,4d and 7d after delivery. The quality of anaesthesia (judged by the anaesthetist), the quality of muscle relaxation (judged by the surgeon) and the degree of intraoperative comfort (judged by the patient) were recorded as excellent, good, fair or poor.
- Statistical Analysis: Statistical analysis was performed using SPSS 13.0 software package. All metering data were recorded as mean ± standard deviation and Independent-Samples T test or One-way ANOVA was used to compare the metering data. Chi-square test was used to compare the enumeration data. p<0.05 indicates that the differences have statistical significance.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine group | Experimental | Drug: bupivacainePregnant women received combined spinal-epidural anesthesia by injecting bupivacaine. The dose of bupivacaine depended on height of subjects. |
| Ropivacaine group | Experimental | Drug: ropivacainePregnant women received combined spinal-epidural anesthesia by injecting ropivacaine. The dose of ropivacaine depended on height of subjects). |
| Control group | No intervention | –Pregnant women received combined spinal-epidural anesthesia by injecting bupivacaine. 2ml bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection for all subjects. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women who were scheduled for cesarean section.
Key exclusion criteria (1 listed)
- Women with cardiovascular disease, fetal abnormalities, placental abruption, placenta previa, placental abnormalities, sidewall placenta, abnormal fetal heart rate and spinal anesthesia contraindications.
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 |
|---|---|---|
| bupivacaine0.5 % bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection according to the height of subjects (1.7 ml for 173~174cm, 1.65 ml for 170~172cm, 1.6 ml for 168~169cm, 1.55 ml for 165~167cm, 1.5 ml for 163~164cm, 1.45 ml for 160~162cm, 1.4 ml for 158~159cm, 1.35 ml for 155~157cm, 1.3 ml for 153~154cm, 1.25 ml for 150~152cm, 1.2 ml for 148~149cm)，1.15 ml for 145~147cm). | Drug | Bupivacaine group |
| ropivacaine0.5 % ropivacaine (1% ropivacaine (1.5 ml) + cerebrospinal fluid (1.5 ml)) was injection according to the height of subjects (2.300 ml for 173~174cm, 2.225 ml for 170~172cm, 2.15 0ml for 168~169cm, 2.075 ml for 165~167cm, 2.000 ml for 163~164cm, 1.925 ml for 160~162cm, 1.850 ml for 158~159cm, 1.775 ml for 155~157cm, 1.700 ml for 153~154cm, 1.625 ml for 150~152cm, 1.55 0ml for 148~149cm, 1.475 ml for 145~147cm) | Drug | Ropivacaine group |
Primary outcome
Incidence of hypotension after anesthesia
Time frame: delivery
Hypotension after anesthesia expressed in number of patients with one or more episodes of hypotension (Systolic blood pressure < 90 mmHg or 70% of baseline value) up to fetal delivery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Derived from this study: PubMed 37131191Huang J, Wen G, Huang Q, Huang B. Anesthesia characteristic of an algorithm of bupivacaine dose based on height in caesarean section under spinal anesthesia: a retrospective cohort study. BMC Anesthesiol. 2023 May 2;23(1):146. doi: 10.1186/s12871-023-02113-0.
- Derived from this study: PubMed 35755061Huang Q, Wen G, Hai C, Zheng Z, Li Y, Huang Z, Huang B. A Height-Based Dosing Algorithm of Bupivacaine in Spinal Anesthesia for Decreasing Maternal Hypotension in Cesarean Section Without Prophylactic Fluid Preloading and Vasopressors: A Randomized-Controlled Non-Inferiority Trial. Front Med (Lausanne). 2022 Jun 10;9:858115. doi: 10.3389/fmed.2022.858115. eCollection 2022.
- Derived from this study: PubMed 31101694Huang B, Huang Q, Hai C, Zheng Z, Li Y, Zhang Z. Height-based dosing algorithm of bupivacaine in spinal anaesthesia for decreasing maternal hypotension in caesarean section without prophylactic fluid preloading and vasopressors: study protocol for a randomised controlled non-inferiority trial. BMJ Open. 2019 May 16;9(5):e024912. doi: 10.1136/bmjopen-2018-024912.
- 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.
Zhongjun Zhang, master study director
ShenZhen People's Hospital of Jinan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine and ropivacaine in people with Cesarean Section and Anesthesia, Spinal, run by Shenzhen People's Hospital at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Nov 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bowan Huang, docter (+86 755-25533018, 285021731@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypotension after anesthesia (time frame: delivery). 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 NCT03497364, which also lists 3 linked publications.
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 18 Nov 2020.