Hemodynamic StabilityPhase 3NCT05706727
Comparative Analytical Study of Intravenous Bolus Dose of Mephentermine and Phenylephrine for Hemodynamic Stability During Elective Cesarean Section Under Spinal Anesthesia at KIST Medical College and Teaching Hospital
A Phase 3 study testing Intravenous bolus dose of Mephentermine and mephentermine and intravenous bolus dose of phenylephrine 50 mcg in people with Hemodynamic Stability, run by KIST Medical and Teaching Hospital at 1 site in Nepal.
Trial summary
Hemodynamics changes with spinal anesthesia is mainly due to sympathetic block which causes mainly hypotension \& bradycardia. Post spinal hypotension usually leads to various adverse maternal and fetal outcomes. Hence, effective prevention and treatment of maternal hypotension is of great clinical significance. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Stability
- What is being tested?
- Intravenous bolus dose of Mephentermine and mephentermine and intravenous bolus dose of phenylephrine 50 mcg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteNepal
- Study dates
- 23 Mar 2023to 15 May 2024
- Phase
- Phase 3
- 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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient undergoing elective cesarean section under spinal anesthesia
- Age between 18-48 years
- ASA class II ( all pregnant are categorized as ASA II)
Who cannot join
- Patient refusal
- Contraindication to spinal anesthesia like coagulation disorder , localized infection , sepsis, raised intracranial pressure etc
- Patchy spinal block , failed spinal block converting to GA
- Hypersensitivity to any drugs
- High Risk Pregnancy ( preeclampsia, eclampsia, preterm, Gestational Diabetes , etc )
Trial locations and contacts
1 site in 1 country.
About this study
Hemodynamics changes with spinal anesthesia is mainly due to sympathetic block which causes mainly hypotension \& bradycardia. Post spinal hypotension usually leads to various adverse maternal and fetal outcomes. Hence, effective prevention and treatment of maternal hypotension is of great clinical significance. Various studies have been done for the prevention of subarachnoid block induced hypotension but the optimal choice of vasopressors for the maintenance of hemodynamic stability during cesarean under spinal anesthesia is still unclear. The ideal vasopressor would be the one which is reliable and easy to use , has rapid onset, short duration of action, easily tritatable, can potentially be used prophylactically and lack any adverse maternal and fetal impact. Thus, aim of study is to compare the hemodynamic stability of mephenterime and phenylephrine during elective cesarean section under spinal anesthesia. The methodology of the study will be prospective, randomized double blinded study where patient meeting inclusion criteria for the study is divided into two groups ( Group M n=21) and ( Group P n= 21) i.e. Group M receives intravenous bolus of mephentermine 6mg and intravenous bolus of 50mcg. Hemodynamics changes in blood pressure and heart rate will monitored and compared among the study groups receiving intravenous boluses of study drugs. Data will be collected in proforma and saved by entering in the MS- EXCEL as well. Data will be analyzed using the statistical package for the social sciences (SPSS) version 27. The categorical data will be analyzed with Chi-square test and numerical variables of hemodynamic parameters between the study groups will be analyzed using student t- test. P-value < 0.05 will be considered statistically significant.
Hence, mephenterime and phenylephrine effectiveness will be studied for hemodynamic stability during cesarean section under spinal anesthesia
Read the detailed description
Spinal anesthesia is the most common administered neuraxial anesthetic technique for patient undergoing cesarean section due to its rapid and reliable onset and remains preferred choice for cesarean deliveries. The advantage of spinal anesthesia includes no airway manipulation, profound analgesia and anesthesia, minimal maternal and fetal drug exposure stable hemodynamic parameters (based on level of anesthesia), decrease intraoperative blood loss and provide postoperative pain control. Hemodynamics changes is due to sympathetic block which causes reduction in venous return which further reduces the cardiac output and blood pressure by activation of Bezold Jarisch reflex In addition, the vasodilatory effect due to prostaglandins, progesterone relaxin and nitric oxide during pregnancy and loss of intrinsic sympathetic vascular tone further exaggerated fall of blood pressure with prevalence of 50-90% despite of fluid preload and uterine displacement Various preventive measures like fluid preload , left lateral tilt , left uterine displacement and along with vasopressors such as mephentermine , phenylephrine have been tried to prevent hypotension Phenylephrine is currently recommended as 1st line of vasopressor which acts as alpha 1 agonist with negligible beta action increasing blood pressure due to vasoconstriction whereas it causes dose dependent bradycardia and decrease cardiac output Mephentermine non catecholamine nondirectly acts on both adrenergic alpha and beta receptors and indirectly by releasing norepinephrine and epinephrine that increases blood pressure and augments cardiac output whereas tachyphylaxis may occur rapidly.
This study would help to compare the effectiveness of phenylephrine and mephentermine for maintenance of hemodynamic parameters in patient undergoing cesarean section under spinal anesthesia.
- Conditions
- Hemodynamic Stability
- Being tested
- Intravenous bolus dose of Mephentermine and mephentermine, intravenous bolus dose of phenylephrine 50 mcg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous bolus dose of Mephentermine and mephentermineDrug
Also called Mephentermine
intravenous bolus dose of mephenteramine 6mg
intravenous bolus dose of phenylephrine 50 mcgDrug
Also called Phenylephrine
intravenous bolus dose of phenylephrine 50 mcg
| Study group | Role | What they receive |
|---|---|---|
| Mephentermine ( M group) | Experimental | Group M Receives: Drug: Intravenous bolus dose of Mephentermine and mephentermine |
| Phenylephrine ( P group ) | Experimental | Group P Receives: Drug: intravenous bolus dose of phenylephrine 50 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the intravenous bolus dose of mephentermine and phenylephrine for hemodynamic stability during elective cesarean section under spinal anesthesia
To measure systolic blood pressure ( SBP) and diastolic blood pressure ( DBP) of the study groups
Measured: 6 months
Secondary outcomes (2)
To measure Mean Arterial Pressure ( MAP ) of study groups
Mean Arterial Pressure will be measured and compared between study groups
Measured: 6 months
To measure heart rate ( HR) of study group
Heart rate will be measured and compared between study groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start23 Mar 2023
- Primary completion29 Apr 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic StabilityStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative Interventional
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- KIST Medical and Teaching Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nepal Health Research Council
- Responsible party
- Principal investigator, Dr. Raju Bikram Basnet, KIST Medical and Teaching Hospital
- Investigators
- Dr. Smriti Koirala, MD, Principal investigator, KIST Medical College and Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706727
- Sponsor's protocol ID
- KISTMTH 01
- Status last verified
- Oct 2024
- First submitted
- 23 Jan 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Habib AS. A review of the impact of phenylephrine administration on maternal hemodynamics and maternal and neonatal outcomes in women undergoing cesarean delivery under spinal anesthesia. Anesth Analg. 2012 Feb;114(2):377-90. doi: 10.1213/ANE.0b013e3182373a3e. Epub 2011 Nov 21.
PubMed 22104076Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.
PubMed 20455872Corke BC, Datta S, Ostheimer GW, Weiss JB, Alper MH. Spinal anaesthesia for Caesarean section. The influence of hypotension on neonatal outcome. Anaesthesia. 1982 Jun;37(6):658-62. doi: 10.1111/j.1365-2044.1982.tb01278.x.
PubMed 7091625Ohpasanon P, Chinachoti T, Sriswasdi P, Srichu S. Prospective study of hypotension after spinal anesthesia for cesarean section at Siriraj Hospital: incidence and risk factors, Part 2. J Med Assoc Thai. 2008 May;91(5):675-80.
PubMed 18672631Campagna JA, Carter C. Clinical relevance of the Bezold-Jarisch reflex. Anesthesiology. 2003 May;98(5):1250-60. doi: 10.1097/00000542-200305000-00030. No abstract available.
PubMed 12717149Mohta M, Janani SS, Sethi AK, Agarwal D, Tyagi A. Comparison of phenylephrine hydrochloride and mephentermine sulphate for prevention of post spinal hypotension. Anaesthesia. 2010 Dec;65(12):1200-5. doi: 10.1111/j.1365-2044.2010.06559.x.
PubMed 21182601Mahajan L, Anand LK, Gombar KK. A randomized double-blinded comparison of ephedrine, phenylephrine and mephentermine infusions to maintain blood pressure during spinal anaesthesia for cesarean delivery: The effects on fetal acid-base status and haemodynamic control. J Anaesthesiol Clin Pharmacol. 2009;25(4):427-32.
Chandak A V., Bhuyan D, Singam AP, Patil B. Comparison of bolus phenylephrine, ephedrine and mephentermine for maintenance of arterial pressure during spinal anaesthesia in caesarean section. Res J Pharm Technol. 2021;14(3):1349-52.
Nag DS, Samaddar DP, Chatterjee A, Kumar H, Dembla A. Vasopressors in obstetric anesthesia: A current perspective. World J Clin Cases. 2015 Jan 16;3(1):58-64. doi: 10.12998/wjcc.v3.i1.58.
PubMed 25610851
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analytical Study of Intravenous Bolus Dose of Mephentermine and Phenylephrine for Hemodynamic Stability During Elective Cesarean Section Under Spinal Anesthesia at KIST Medical College and Teaching Hospital
- ClinicalTrials.gov ID
- NCT05706727
- Acronym / sponsor ID
- KISTMTH 01
- Conditions
- Hemodynamic Stability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- KIST Medical and Teaching HospitalUniversity, hospital or other
- Collaborators
- Nepal Health Research Council
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 31 Jan 2023 (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.
Hemodynamics changes with spinal anesthesia is mainly due to sympathetic block which causes mainly hypotension \& bradycardia. Post spinal hypotension usually leads to various adverse maternal and fetal outcomes. Hence, effective prevention and treatment of maternal hypotension is of great clinical significance. Various studies have been done for the prevention of subarachnoid block induced hypotension but the optimal choice of vasopressors for the maintenance of hemodynamic stability during cesarean under spinal anesthesia is still unclear. The ideal vasopressor would be the one which is reliable and easy to use , has rapid onset, short duration of action, easily tritatable, can potentially be used prophylactically and lack any adverse maternal and fetal impact. Thus, aim of study is to compare the hemodynamic stability of mephenterime and phenylephrine during elective cesarean section under spinal anesthesia. The methodology of the study will be prospective, randomized double blinded study where patient meeting inclusion criteria for the study is divided into two groups ( Group M n=21) and ( Group P n= 21) i.e. Group M receives intravenous bolus of mephentermine 6mg and intravenous bolus of 50mcg. Hemodynamics changes in blood pressure and heart rate will monitored and compared among the study groups receiving intravenous boluses of study drugs. Data will be collected in proforma and saved by entering in the MS- EXCEL as well. Data will be analyzed using the statistical package for the social sciences (SPSS) version 27. The categorical data will be analyzed with Chi-square test and numerical variables of hemodynamic parameters between the study groups will be analyzed using student t- test. P-value < 0.05 will be considered statistically significant.
Hence, mephenterime and phenylephrine effectiveness will be studied for hemodynamic stability during cesarean section under spinal anesthesia
Detailed description
Spinal anesthesia is the most common administered neuraxial anesthetic technique for patient undergoing cesarean section due to its rapid and reliable onset and remains preferred choice for cesarean deliveries. The advantage of spinal anesthesia includes no airway manipulation, profound analgesia and anesthesia, minimal maternal and fetal drug exposure stable hemodynamic parameters (based on level of anesthesia), decrease intraoperative blood loss and provide postoperative pain control. Hemodynamics changes is due to sympathetic block which causes reduction in venous return which further reduces the cardiac output and blood pressure by activation of Bezold Jarisch reflex In addition, the vasodilatory effect due to prostaglandins, progesterone relaxin and nitric oxide during pregnancy and loss of intrinsic sympathetic vascular tone further exaggerated fall of blood pressure with prevalence of 50-90% despite of fluid preload and uterine displacement Various preventive measures like fluid preload , left lateral tilt , left uterine displacement and along with vasopressors such as mephentermine , phenylephrine have been tried to prevent hypotension Phenylephrine is currently recommended as 1st line of vasopressor which acts as alpha 1 agonist with negligible beta action increasing blood pressure due to vasoconstriction whereas it causes dose dependent bradycardia and decrease cardiac output Mephentermine non catecholamine nondirectly acts on both adrenergic alpha and beta receptors and indirectly by releasing norepinephrine and epinephrine that increases blood pressure and augments cardiac output whereas tachyphylaxis may occur rapidly.
This study would help to compare the effectiveness of phenylephrine and mephentermine for maintenance of hemodynamic parameters in patient undergoing cesarean section under spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparative Interventional
| Arm | Type | Receives |
|---|---|---|
| Mephentermine ( M group) | Experimental | Drug: Intravenous bolus dose of Mephentermine and mephentermineGroup M |
| Phenylephrine ( P group ) | Experimental | Drug: intravenous bolus dose of phenylephrine 50 mcgGroup P |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient undergoing elective cesarean section under spinal anesthesia
- Age between 18-48 years
- ASA class II ( all pregnant are categorized as ASA II)
Key exclusion criteria (5 listed)
- Patient refusal
- Contraindication to spinal anesthesia like coagulation disorder , localized infection , sepsis, raised intracranial pressure etc
- Patchy spinal block , failed spinal block converting to GA
- Hypersensitivity to any drugs
- High Risk Pregnancy ( preeclampsia, eclampsia, preterm, Gestational Diabetes , etc )
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 |
|---|---|---|
| Intravenous bolus dose of Mephentermine and mephentermineAlso: Mephentermineintravenous bolus dose of mephenteramine 6mg | Drug | Mephentermine ( M group) |
| intravenous bolus dose of phenylephrine 50 mcgAlso: Phenylephrineintravenous bolus dose of phenylephrine 50 mcg | Drug | Phenylephrine ( P group ) |
Primary outcome
To compare the intravenous bolus dose of mephentermine and phenylephrine for hemodynamic stability during elective cesarean section under spinal anesthesia
Time frame: 6 months
To measure systolic blood pressure ( SBP) and diastolic blood pressure ( DBP) of the study groups
2 secondary outcomes
To measure Mean Arterial Pressure ( MAP ) of study groups
Time frame: 6 months
To measure heart rate ( HR) of study group
Time frame: 6 months
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 9 Oct 2024.
- Background: PubMed 22104076Habib AS. A review of the impact of phenylephrine administration on maternal hemodynamics and maternal and neonatal outcomes in women undergoing cesarean delivery under spinal anesthesia. Anesth Analg. 2012 Feb;114(2):377-90. doi: 10.1213/ANE.0b013e3182373a3e. Epub 2011 Nov 21.
- Background: PubMed 20455872Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.
- Background: PubMed 7091625Corke BC, Datta S, Ostheimer GW, Weiss JB, Alper MH. Spinal anaesthesia for Caesarean section. The influence of hypotension on neonatal outcome. Anaesthesia. 1982 Jun;37(6):658-62. doi: 10.1111/j.1365-2044.1982.tb01278.x.
- Background: PubMed 18672631Ohpasanon P, Chinachoti T, Sriswasdi P, Srichu S. Prospective study of hypotension after spinal anesthesia for cesarean section at Siriraj Hospital: incidence and risk factors, Part 2. J Med Assoc Thai. 2008 May;91(5):675-80.
- Background: PubMed 12717149Campagna JA, Carter C. Clinical relevance of the Bezold-Jarisch reflex. Anesthesiology. 2003 May;98(5):1250-60. doi: 10.1097/00000542-200305000-00030. No abstract available.
- Background: PubMed 21182601Mohta M, Janani SS, Sethi AK, Agarwal D, Tyagi A. Comparison of phenylephrine hydrochloride and mephentermine sulphate for prevention of post spinal hypotension. Anaesthesia. 2010 Dec;65(12):1200-5. doi: 10.1111/j.1365-2044.2010.06559.x.
- BackgroundMahajan L, Anand LK, Gombar KK. A randomized double-blinded comparison of ephedrine, phenylephrine and mephentermine infusions to maintain blood pressure during spinal anaesthesia for cesarean delivery: The effects on fetal acid-base status and haemodynamic control. J Anaesthesiol Clin Pharmacol. 2009;25(4):427-32.
- BackgroundChandak A V., Bhuyan D, Singam AP, Patil B. Comparison of bolus phenylephrine, ephedrine and mephentermine for maintenance of arterial pressure during spinal anaesthesia in caesarean section. Res J Pharm Technol. 2021;14(3):1349-52.
- Background: PubMed 25610851Nag DS, Samaddar DP, Chatterjee A, Kumar H, Dembla A. Vasopressors in obstetric anesthesia: A current perspective. World J Clin Cases. 2015 Jan 16;3(1):58-64. doi: 10.12998/wjcc.v3.i1.58.
- 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.
Dr. Smriti Koirala, MD principal investigator
KIST Medical College and Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous bolus dose of Mephentermine and mephentermine and intravenous bolus dose of phenylephrine 50 mcg in people with Hemodynamic Stability, run by KIST Medical and Teaching Hospital 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 5 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 9 Oct 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To compare the intravenous bolus dose of mephentermine and phenylephrine for hemodynamic stability during elective cesarean section under spinal anesthesia (time frame: 6 months). 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 NCT05706727, which also lists 9 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 9 Oct 2024.