Maternal Hypotension After Spinal AnesthesiaPhase 4NCT04082676
Height Versus Height and Weight Based Spinal Bupivacaine on Maternal Haemodynamics for Elective Cesarean in Short Stature Patients
A Phase 4 study testing Hyperbaric bupivacaine spinal in people with Maternal Hypotension After Spinal Anesthesia, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
Doses of intrathecal bupivacaine based on patients either height or height and weight has shown to lower the risk of maternal hypotension with similar quality of anesthesia compared to conventional doses. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Maternal Hypotension After Spinal Anesthesia
- What is being tested?
- Hyperbaric bupivacaine spinal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteNepal
- Study dates
- 30 Nov 2019to 1 Sep 2021
- Phase
- Phase 4
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with full-term gestation undergoing planned Caesarean section under spinal anesthesia
- Who provide consent .
- Height less than 150 cm
Who cannot join
- Patients with height <140 cm,
- Hypertensive disorders of pregnancy,
- Placental disorders,
- Body mass index ≥ 40 kg/m2,
- Diabetes mellitus
- Cardiovascular
Show all 16Show fewer
- Cerebrovascular
- Hormonal disorder
- Renal disease
- Polyhydramnios
- Known case of bad obstetric history
- Fetal abnormalities
- Baseline systolic blood pressure (SBP) less than 100 mmHg
- Contraindication to spinal anaesthesia
- Allergy to any drug used in the study and
- Those unable to understand and sign the consent form
Trial locations and contacts
1 site in 1 country.
Nepal1 site
BP Koirala Institute of Health Sciences (BPKIHS)
Dharān, Koshi, 56700
About this study
Official title: Effect of Height Versus Height and Weight Based Intrathecal Bupivacaine Dose on Maternal Haemodynamics for Elective Caesarean Section in Short Stature Patients: A Randomized Trial
Doses of intrathecal bupivacaine based on patients either height or height and weight has shown to lower the risk of maternal hypotension with similar quality of anesthesia compared to conventional doses.
In clinical practice there is a tendency of reducing the dose of bupivacaine as either low fixed dose or using the doses based on either height and weight or height (0.06mg/cm) alone in parturient with short stature. However, there is lack of evidence regarding the appropriate dose required in this group of patients. Therefore, our aim is to compare the height versus height and weight based intrathecal bupivacaine dose for elective caesarean on maternal haemodynamics in short stature patients.
Read the detailed description
Spinal induced hypotension in women undergoing caesarean section (CS) is the most common unwanted effect. The dose of intrathecal local anesthetic is the main determining factor that balances between successful block and an incidence of maternal hypotension. Although lowering the doses of intrathecal bupivacaine provides better maternal hemodynamic stability it compromises the quality of anesthesia. Moreover, there is no consensus regarding the cut-off at which the dose can be defined as low. Doses based on patients either height or height and weight has shown to lower the risk of maternal hypotension with similar quality of anesthesia compared to conventional doses.
In clinical practice there is a tendency of reducing the dose of bupivacaine as either low fixed dose or using the doses based on either height and weight or height (0.06mg/cm) alone in parturient with short stature. However, there is lack of evidence regarding the appropriate dose required in this group of patients.
Our aim is to compare the height versus height and weight based intrathecal bupivacaine dose for elective caesarean on maternal haemodynamics in short stature patients.
Doses of intrathecal bupivacaine for elective caesarean section based on Harten chart is available from the following reference- Harten JM, Boyne I, Hannah P, Varveris D, Brown A. Effects of a height and weight adjusted dose of local anaesthetic for spinal anaesthesia for elective Caesarean section. Anaesthesia 2005; 60: 348-53.
Consent for the participation in the study will be obtained during pre-anaesthetic assessment visits in the evening before surgery. The investigator will also educate the patients regarding the use of numeric rating scale scores. Preoperative anxiety will be recorded in numerical rating scale scores where 0 is no anxiety and 10 is maximum anxiety patient reported. The enrolled subjects will be randomly assigned to 2 equal groups (allocation ratio, 1:1) according to the codes generated from the website (www.sealedenvleop.com) using the variable block size of 4, 6 and 8. The group allocation will be concealed in sequentially numbered, sealed opaque envelopes that will be opened by the anaesthesia assistant not involved in the study only after the patient arrives in the operating room. The patient will be fasted for at least eight hours and will receive antibiotics, ranitidine 50 mg and metoclopramide 10 mg intravenously via 18-gauge cannula before transfer to the operation room. In the operating table patient will be laid supine with a wedge under right buttock and standard monitors (electrocardiography, pulse oximetry, and noninvasive BP) will be applied. Thereafter, successive three readings of heart rate (HR) and systolic blood pressure (SBP) will be taken at 2 minutes interval with difference not exceeding 10%. The average of these recordings will be documented by the investigators as baseline parameters. To maintain blinding, the investigator will leave the operating room and will return immediately once the spinal injection is initiated. Subarachnoid block will be performed by the attending anesthesiologist not involved in the study in the sitting position at the L3-L4 or L4-L5 vertebral interspace using a 25-gauge spinal needle via midline approach. The study solution will be administered according to the group allocated. In Group A the dose of heavy bupivacaine will be based on height and weight and in group B the dose will be based on patient's height (0.06 mg/cm). 10 microgram fentanyl will be added to bupivacaine in both groups.
- Being tested
- Hyperbaric bupivacaine spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric bupivacaine spinalDrug
In this group patient will receive intrathecal hyperbaric bupivacaine based on patients height and weight according to Harten chart with 10 μg of fentanyl (0.1 ml)
Hyperbaric bupivacaine spinalDrug
In this group will receive intrathecal hyperbaric bupivacaine based on patients height (0.06mg/cm) with 10 μg of fentanyl (0.1 ml)
| Study group | Role | What they receive |
|---|---|---|
| Height and weight based group | Experimental | Patients in "Height and weight based group" will receive intrathecal hyperbaric bupivacaine based on patients height and weight according to Harten chart with 10 μg of fentanyl (0.1 ml) Receives: Drug: Hyperbaric bupivacaine spinal |
| Height based group | Active comparator | Patients in "Height based group" will receive intrathecal hyperbaric bupivacaine based on patients height i.e. (0.06mg/cm) with 10 μg of fentanyl (0.1 ml) Receives: Drug: Hyperbaric bupivacaine spinal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-spinal hypotension
Number of patients with post spinal hypotension (defined as systolic blood pressure in mmHg, <10% of the baseline reading or SBP < 100 mm Hg observed from spinal injection until delivery of baby
Measured: Up to delivery of baby
Secondary outcomes (23)
Incidence of post-delivery hypotension
Number of patients with post delivery hypotension (defined as systolic blood pressure in mmHg, <10% from the baseline reading or systolic blood pressure < 100 mm Hg observed after delivery of the fetus and starting oxytocin infusion until end of surgery
Measured: Up to end of surgery
Incidence of post-spinal hypotension
Number of patients with post spinal hypotension (defined as systolic blood pressure in mmHg, <20% of the baseline reading or SBP < 100 mm Hg observed from spinal injection until delivery of baby
Measured: Up to delivery of baby
Incidence of post-delivery hypotension
Number of patients with post delivery hypotension (defined as systolic blood pressure in mmHg, <20% of the baseline reading or systolic blood pressure < 100 mm Hg observed after delivery of the fetus and starting oxytocin infusion until end of surgery
Measured: Up to end of surgery
Lowest systolic blood pressure
lowest systolic blood pressure (SBP) recorded in mmHg from spinal injection until delivery and then end of surgery.
Measured: Up to end of surgery
Vasopressor requirement
Hypotension associated without bradycardia will be treated with phenylepinephrine. Hypotension associated with bradycardia (HR 50/min) will be treated with IV ephedrine 6 mg and followed by IV atropine 0.5 mg.
Measured: Up to end of surgery
Incidence of bradycardia
Number of patients with heart rate < 50 beats/min
Measured: Up to end of surgery
Incidence of nausea vomiting
Number of patients complaining nausea and vomiting. Patients will be instructed to report intraoperative nausea based on an 11-point Numeric Rating Score (NRS), where 0 describes "no nausea" and 10 describes nausea "as worst as it could be". Score more than 0 will be considered as nausea. Patients reporting NRS score > 3 for nausea or vomiting will be managed with IV ondensetron 4 mg. If nausea and vomiting persisted after 5 min, IV dexamethasone 4 mg will be administered.
Measured: Up to end of surgery
Incidence of shivering
Number of patients with shivering. Intraoperative shivering will be graded as : 0 no shivering, 1 one or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis without other cause, but without visible muscular activity; 2 visible muscular activity confined to one muscle group; 3 visible muscular activity in more than one muscle group; and 4 gross muscular activity involving the whole body. If the shivering score is ≥3, IV meperidine 20 mg will be administered.
Measured: Up to end of surgery
Intraoperative analgesia requirement
Number of patient requiring intraoperative supplemental analgesia. Patients will be instructed to report intraoperative pain based on an 11-point Numeric Rating Score (NRS), where 0 describes "no pain" and 10 describes worst pain "as worst as it could be". It will be assessed using NRS scores at the following intervals: skin incision, delivery, uterine exteriorization, peritoneal closure, and skin closure. If patients reported pain or discomfort (if NRS is mild i.e scores between 1-3), then IV fentanyl 20 microgram will be given and second dose will be repeated if needed. If pain still persists then IV ketamine 0.25 mg/kg will be given.
Measured: Up to end of surgery
Systolic blood pressure
Systolic blood pressure in mmHg measured from baseline until end of surgery
Measured: Up to end of surgery
Quality of anaesthesia
Assessed using a four-point scale: 1=excellent, 2=good; some feelings but no discomfort, 3=fair; some discomfort but rescue analgesia unnecessary, 4=poor; major discomfort and rescue analgesia required.
Measured: At 1 to 2 hours in Post anesthesia care unit
quality of operating condition
Surgeons will be asked to grade operating conditions as "very good," "good," or "poor."
Measured: Up to end of surgery
Intraoperative sedation
Assessed at 5 min interval after IT injection using a 5-point ordinal scale, where 0 = Awake and alert; 1 = resting with eyes closed; 2 = drowsy and responsive to verbal stimuli; 3 = drowsy and responsive to physical stimuli and 4 = unarousable.
Measured: Up to end of surgery
Maternal satisfaction with intraoperative anesthesia for cesarean delivery
It will be recorded before discharge from PACU using a NRS with "very dissatisfied" at 0 cm and "very satisfied" at 10 cm.
Measured: up to 1-2 hours stay Post anesthesia care unit
Incidence of pruritus
Number of patients with pruritus. Intraoperative pruritus will be assessed using NRS scale (0 - 10 scale, with 0, no pruritus, and 10, worst pruritus imaginable). NRS score > 3 will be treated with IV chlorpheniramine 10 mg.
Measured: Up to end of surgery
Duration of pain free period
Duration of analgesia in hours (time elapsed between intrathecal injection and the first perception of pain) will be noted
Measured: up to 24 h after surgery
Incidence of dizziness
Number of patients complaining dizziness
Measured: up to end of surgery
Time to sensory block reached to 6th thoracic dermatome
After spinal anesthesia the time required for sensory block to reach 6th thoracic dermatome
Measured: Up to 10 min from injection of spinal anesthesia
Maximum level of sensory block reached
level of maximum thoracic/cervical dermatome reached after spinal anesthesia
Measured: Up to end of surgery
Time to sensory block regressed to 10th thoracic dermatome
After spinal anesthesia the time required for sensory block to regress to 10th thoracic dematome
Measured: Up to 24 hour after surgery
Time to complete motor blockade
Time to Bromage scale 3. Motor block will be assessed using the Bromage scale (0-3): 0, able to straight leg raise (SLR) and flex both feet and knees; 1, unable to SLR, able to flex knees and feet; 2, unable to SLR or flex knees, able to flex feet; and 3, unable to move legs or feet.
Measured: Upto 15 min after spinal anesthesia
Time to motor blockage regression
Time to Bromage scale regression to 0. Motor block will be assessed using the Bromage scale (0-3): 0, able to straight leg raise (SLR) and flex both feet and knees; 1, unable to SLR, able to flex knees and feet; 2, unable to SLR or flex knees, able to flex feet; and 3, unable to move legs or feet.
Measured: Up to 24 hour after surgery
Apgar score
Neonatal Apgar scores after delivery assessed by attending pediatrician. It is determined by evaluating the newborn baby on five criteria(Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low requiring immediate resuscitation.
Measured: 5 and 10 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start30 Nov 2019
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
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 Maternal Hypotension After Spinal AnesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Asish Subedi, B.P. Koirala Institute of Health Sciences
- Investigators
- Asish Subedi, MD, Principal investigator, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082676
- Sponsor's protocol ID
- IRC/1525/019
- Status last verified
- Mar 2022
- First submitted
- 1 Sep 2019
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final research data will be stored in Mendeley. The final data will be released and shared during the publication process of the manuscript.
Publications
Subedi A, Thapa P, Prajapati R, Schyns-van den Berg AMJV. Effect of height versus height/weight-based spinal bupivacaine on maternal hemodynamics for elective cesarean in short stature patients: a randomized clinical trial. J Anesth. 2023 Dec;37(6):905-913. doi: 10.1007/s00540-023-03252-x. Epub 2023 Sep 14.
PubMed 37709952
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Height Versus Height and Weight Based Intrathecal Bupivacaine Dose on Maternal Haemodynamics for Elective Caesarean Section in Short Stature Patients: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04082676
- Acronym / sponsor ID
- IRC/1525/019
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 9 Sep 2019 (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.
Doses of intrathecal bupivacaine based on patients either height or height and weight has shown to lower the risk of maternal hypotension with similar quality of anesthesia compared to conventional doses.
In clinical practice there is a tendency of reducing the dose of bupivacaine as either low fixed dose or using the doses based on either height and weight or height (0.06mg/cm) alone in parturient with short stature. However, there is lack of evidence regarding the appropriate dose required in this group of patients. Therefore, our aim is to compare the height versus height and weight based intrathecal bupivacaine dose for elective caesarean on maternal haemodynamics in short stature patients.
Detailed description
Spinal induced hypotension in women undergoing caesarean section (CS) is the most common unwanted effect. The dose of intrathecal local anesthetic is the main determining factor that balances between successful block and an incidence of maternal hypotension. Although lowering the doses of intrathecal bupivacaine provides better maternal hemodynamic stability it compromises the quality of anesthesia. Moreover, there is no consensus regarding the cut-off at which the dose can be defined as low. Doses based on patients either height or height and weight has shown to lower the risk of maternal hypotension with similar quality of anesthesia compared to conventional doses.
In clinical practice there is a tendency of reducing the dose of bupivacaine as either low fixed dose or using the doses based on either height and weight or height (0.06mg/cm) alone in parturient with short stature. However, there is lack of evidence regarding the appropriate dose required in this group of patients.
Our aim is to compare the height versus height and weight based intrathecal bupivacaine dose for elective caesarean on maternal haemodynamics in short stature patients.
Doses of intrathecal bupivacaine for elective caesarean section based on Harten chart is available from the following reference- Harten JM, Boyne I, Hannah P, Varveris D, Brown A. Effects of a height and weight adjusted dose of local anaesthetic for spinal anaesthesia for elective Caesarean section. Anaesthesia 2005; 60: 348-53.
Consent for the participation in the study will be obtained during pre-anaesthetic assessment visits in the evening before surgery. The investigator will also educate the patients regarding the use of numeric rating scale scores. Preoperative anxiety will be recorded in numerical rating scale scores where 0 is no anxiety and 10 is maximum anxiety patient reported. The enrolled subjects will be randomly assigned to 2 equal groups (allocation ratio, 1:1) according to the codes generated from the website (www.sealedenvleop.com) using the variable block size of 4, 6 and 8. The group allocation will be concealed in sequentially numbered, sealed opaque envelopes that will be opened by the anaesthesia assistant not involved in the study only after the patient arrives in the operating room. The patient will be fasted for at least eight hours and will receive antibiotics, ranitidine 50 mg and metoclopramide 10 mg intravenously via 18-gauge cannula before transfer to the operation room. In the operating table patient will be laid supine with a wedge under right buttock and standard monitors (electrocardiography, pulse oximetry, and noninvasive BP) will be applied. Thereafter, successive three readings of heart rate (HR) and systolic blood pressure (SBP) will be taken at 2 minutes interval with difference not exceeding 10%. The average of these recordings will be documented by the investigators as baseline parameters. To maintain blinding, the investigator will leave the operating room and will return immediately once the spinal injection is initiated. Subarachnoid block will be performed by the attending anesthesiologist not involved in the study in the sitting position at the L3-L4 or L4-L5 vertebral interspace using a 25-gauge spinal needle via midline approach. The study solution will be administered according to the group allocated. In Group A the dose of heavy bupivacaine will be based on height and weight and in group B the dose will be based on patient's height (0.06 mg/cm). 10 microgram fentanyl will be added to bupivacaine in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Height and weight based group | Experimental | Drug: Hyperbaric bupivacaine spinalPatients in "Height and weight based group" will receive intrathecal hyperbaric bupivacaine based on patients height and weight according to Harten chart with 10 μg of fentanyl (0.1 ml) |
| Height based group | Active comparator | Drug: Hyperbaric bupivacaine spinalPatients in "Height based group" will receive intrathecal hyperbaric bupivacaine based on patients height i.e. (0.06mg/cm) with 10 μg of fentanyl (0.1 ml) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with full-term gestation undergoing planned Caesarean section under spinal anesthesia
- Who provide consent .
- Height less than 150 cm
Key exclusion criteria (16 listed)
- Patients with height <140 cm,
- Hypertensive disorders of pregnancy,
- Placental disorders,
- Body mass index ≥ 40 kg/m2,
- Diabetes mellitus
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 |
|---|---|---|
| Hyperbaric bupivacaine spinalIn this group patient will receive intrathecal hyperbaric bupivacaine based on patients height and weight according to Harten chart with 10 μg of fentanyl (0.1 ml) | Drug | Height and weight based group |
| Hyperbaric bupivacaine spinalIn this group will receive intrathecal hyperbaric bupivacaine based on patients height (0.06mg/cm) with 10 μg of fentanyl (0.1 ml) | Drug | Height based group |
Primary outcome
Incidence of post-spinal hypotension
Time frame: Up to delivery of baby
Number of patients with post spinal hypotension (defined as systolic blood pressure in mmHg, <10% of the baseline reading or SBP < 100 mm Hg observed from spinal injection until delivery of baby
23 secondary outcomes
Incidence of post-delivery hypotension
Time frame: Up to end of surgery
Incidence of post-spinal hypotension
Time frame: Up to delivery of baby
Incidence of post-delivery hypotension
Time frame: Up to end of surgery
Lowest systolic blood pressure
Time frame: Up to end of surgery
Vasopressor requirement
Time frame: Up to end of surgery
Incidence of bradycardia
Time frame: Up to end of surgery
Incidence of nausea vomiting
Time frame: Up to end of surgery
Incidence of shivering
Time frame: Up to end of surgery
Intraoperative analgesia requirement
Time frame: Up to end of surgery
Systolic blood pressure
Time frame: Up to end of surgery
Quality of anaesthesia
Time frame: At 1 to 2 hours in Post anesthesia care unit
quality of operating condition
Time frame: Up to end of surgery
Intraoperative sedation
Time frame: Up to end of surgery
Maternal satisfaction with intraoperative anesthesia for cesarean delivery
Time frame: up to 1-2 hours stay Post anesthesia care unit
Incidence of pruritus
Time frame: Up to end of surgery
Duration of pain free period
Time frame: up to 24 h after surgery
Incidence of dizziness
Time frame: up to end of surgery
Time to sensory block reached to 6th thoracic dermatome
Time frame: Up to 10 min from injection of spinal anesthesia
Maximum level of sensory block reached
Time frame: Up to end of surgery
Time to sensory block regressed to 10th thoracic dermatome
Time frame: Up to 24 hour after surgery
Time to complete motor blockade
Time frame: Upto 15 min after spinal anesthesia
Time to motor blockage regression
Time frame: Up to 24 hour after surgery
Apgar score
Time frame: 5 and 10 minutes after delivery
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 22 Mar 2022.
- Derived from this study: PubMed 37709952Subedi A, Thapa P, Prajapati R, Schyns-van den Berg AMJV. Effect of height versus height/weight-based spinal bupivacaine on maternal hemodynamics for elective cesarean in short stature patients: a randomized clinical trial. J Anesth. 2023 Dec;37(6):905-913. doi: 10.1007/s00540-023-03252-x. Epub 2023 Sep 14.
- Individual participant dataSharing planned: Yes. The final research data will be stored in Mendeley. The final data will be released and shared during the publication process of the manuscript.
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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.
Asish Subedi, MD principal investigator
B.P. Koirala Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperbaric bupivacaine spinal in people with Maternal Hypotension After Spinal Anesthesia, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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 3 inclusion and 16 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 22 Mar 2022. 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 Nepal. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of post-spinal hypotension (time frame: Up to delivery of baby). 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 NCT04082676, 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 22 Mar 2022.