Spinal Anesthesia Induced HypotensionNCT06836986
COMPARISON BETWEEN EFFICACY OF NOREPINEPHRINE AND PHENYLEPHRINE BOLUSES for PREVENTION OF SPINAL ANAESTHESIA INDUCED HYPOTENSION IN OBSTETRICAL PATIENTS UNDERGOING EMERGENCY CESAREAN SECTION-A Double Blind Randomized Controlled Trial
A study testing Norepinephrine Bolus and Phenylephrine bolus in people with Spinal Anesthesia Induced Hypotension, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn if norepinephrine is more effective than phenylephrine for prevention of spinal anesthesia induced hypotension. The main questions it aims to answer are: Does norepinephrine lower the incidence of spinal anesthesia induced hypotension in emergency obstetrical patients? We… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Spinal Anesthesia Induced Hypotension
- What is being tested?
- Norepinephrine Bolus and Phenylephrine bolus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 sitePakistan
- Study dates
- 31 Dec 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- American society of anesthesiologists II and III patients
- Age 18-40years
- Gestational age 32 weeks and above
Who cannot join
- Patients with hypertensive disorders of pregnancy having baseline systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 99 mmHg.
- Baseline mean arterial pressure less than 70 mmHg.
- Antepartum hemorrhage/intraoperative blood loss greater than 1000ml
- history indicative of cardiovascular or neurological disease.
- known fetal abnormality.
- Patients taking serotonin reuptake inhibitor, Tricyclic antidepressants,monoamine oxidase inhibitors.
- Maternal situations requiring immediate administration of general anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Dr Ruth km pfau civil hospital karachi Dow University of health sciences, department of anesthesiology
Karachi, Sindh, 74200
Rabia Kamal, FCPS Tainee
About this study
Official title: COMPARISON BETWEEN EFFICACY OF NOREPINEPHRINE AND PHENYLEPHRINE BOLUSES FOR PREVENTION OF SPINAL ANAESTHESIA INDUCED HYPOTENSION IN OBSTETRICAL PATIENTS UNDERGOING EMERGENCY CESAREAN SECTION- A Double Blind Randomized Controlled Trial
The goal of this clinical trial is to learn if norepinephrine is more effective than phenylephrine for prevention of spinal anesthesia induced hypotension. The main questions it aims to answer are:
Does norepinephrine lower the incidence of spinal anesthesia induced hypotension in emergency obstetrical patients? We will compare effectiveness of norepinephrine and phenylephrine for the prevention of spinal anesthesia induced hypotension.
Participants will:
Be administered prophylactic boluses of both drugs right after spinal anesthesia induction and maternal hemodynamic parameters and neonatal APGAR scores will be recorded
Read the detailed description
Spinal anesthesia is a common mode of anesthesia in cesarean delivery. Spinal anesthesia induced hypotension is one of the most common complication that can affect both mother and fetus. For the management of spinal anesthesia induced hypotension, preloading with crystalloids and colloids, use on ionotropic agents and vasopressors have already been in practice.
Objective of this study is to compare efficacy of prophylactic use of norepinephrine and phenylephrine bolus dosage for spinal anesthesia induced hypotension.
This study is being conducted at the department of anesthesiology ,K.M Pfau civil hospital, Dow university of health sciences, Karachi , Pakistan. Data is being collected after taking approval from Institutional review board and written informed consent from the participants.
Participants are being enrolled by primary investigator. All participants are undergoing simple randomization by lottery method.
After enrollment of participants, demographic data, hemodynamic parameters and other relevant details are being recorded till delivery of the neonate.
Hemodynamic parameters that are heart rate, systolic and diastolic blood pressure, mean arterial blood pressure is being recorded every 3mins. APGAR scoring of neonate is also being recorded.
After completion of data collection, data will be done using Statistical package for social sciences 26.
- Conditions
- Spinal Anesthesia Induced Hypotension
- Being tested
- Norepinephrine Bolus, Phenylephrine bolus
- Keywords
- Spinal anesthesia induced hypotension, Emergency lower segment cesarean section, Norepinephrine bolus, Prophylactic, Phenylephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine BolusDrug
Prophylactic norepinephrine bolus of 8 micrograms will be administered right after spinal anesthesia induction.
Rescue bolus of norepinephrine 4 micrograms will be administered in case of hypotension.
Phenylephrine bolusDrug
Prophylactic phenylephrine bolus of 100 micrograms will be administered right after spinal anesthesia induction.
Rescue bolus of phenylephrine 50 micrograms will be administered in case of hypotension.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Active comparator | Prophylactic bolus of phenylephrine will be administered right after spinal anesthesia induction Receives: Drug: Phenylephrine bolus |
| Group N | Experimental | Prophylactic bolus of norepinephrine will be administered right after spinal anesthesia. Receives: Drug: Norepinephrine Bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of spinal anesthesia induced Hypotension
Prophylactic norepinephrine and phenylephrine boluses will be administered to both groups right after spinal anesthesia induction.greater than 80% drop of the Systolic blood pressure will be defined as hypotension.
Measured: From induction of spinal anesthesia till delivery of neonate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start31 Dec 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Anesthesia Induced HypotensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study has two groups of participants. Group N and group P. Allocation of participants in each group is being done by basic randomization.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Kamal, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836986
- Sponsor's protocol ID
- spinal induced hypotension
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: participants confidentiality
Publications
Nadella H, Islam A, Ina EA, Levin D, Bacoat-Jones T. The Management of Spinal and Epidural Anesthesia-Related Hypotension in the United States During Cesarean Childbirth. Cureus. 2024 Mar 17;16(3):e56340. doi: 10.7759/cureus.56340. eCollection 2024 Mar.
PubMed 38633922Ng K, Parsons J, Cyna AM, Middleton P. Spinal versus epidural anaesthesia for caesarean section. Cochrane Database Syst Rev. 2004;2004(2):CD003765. doi: 10.1002/14651858.CD003765.pub2.
PubMed 15106218
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON BETWEEN EFFICACY OF NOREPINEPHRINE AND PHENYLEPHRINE BOLUSES FOR PREVENTION OF SPINAL ANAESTHESIA INDUCED HYPOTENSION IN OBSTETRICAL PATIENTS UNDERGOING EMERGENCY CESAREAN SECTION- A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06836986
- Acronym / sponsor ID
- spinal induced hypotension
- Conditions
- Spinal Anesthesia Induced Hypotension
- Keywords
- Spinal anesthesia induced hypotension, Emergency lower segment cesarean section, Norepinephrine bolus, Prophylactic, Phenylephrine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 20 Feb 2025 (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.
The goal of this clinical trial is to learn if norepinephrine is more effective than phenylephrine for prevention of spinal anesthesia induced hypotension. The main questions it aims to answer are:
Does norepinephrine lower the incidence of spinal anesthesia induced hypotension in emergency obstetrical patients? We will compare effectiveness of norepinephrine and phenylephrine for the prevention of spinal anesthesia induced hypotension.
Participants will:
Be administered prophylactic boluses of both drugs right after spinal anesthesia induction and maternal hemodynamic parameters and neonatal APGAR scores will be recorded
Detailed description
Spinal anesthesia is a common mode of anesthesia in cesarean delivery. Spinal anesthesia induced hypotension is one of the most common complication that can affect both mother and fetus. For the management of spinal anesthesia induced hypotension, preloading with crystalloids and colloids, use on ionotropic agents and vasopressors have already been in practice.
Objective of this study is to compare efficacy of prophylactic use of norepinephrine and phenylephrine bolus dosage for spinal anesthesia induced hypotension.
This study is being conducted at the department of anesthesiology ,K.M Pfau civil hospital, Dow university of health sciences, Karachi , Pakistan. Data is being collected after taking approval from Institutional review board and written informed consent from the participants.
Participants are being enrolled by primary investigator. All participants are undergoing simple randomization by lottery method.
After enrollment of participants, demographic data, hemodynamic parameters and other relevant details are being recorded till delivery of the neonate.
Hemodynamic parameters that are heart rate, systolic and diastolic blood pressure, mean arterial blood pressure is being recorded every 3mins. APGAR scoring of neonate is also being recorded.
After completion of data collection, data will be done using Statistical package for social sciences 26.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study has two groups of participants. Group N and group P. Allocation of participants in each group is being done by basic randomization.
| Arm | Type | Receives |
|---|---|---|
| Group P | Active comparator | Drug: Phenylephrine bolusProphylactic bolus of phenylephrine will be administered right after spinal anesthesia induction |
| Group N | Experimental | Drug: Norepinephrine BolusProphylactic bolus of norepinephrine will be administered right after spinal anesthesia. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American society of anesthesiologists II and III patients
- Age 18-40years
- Gestational age 32 weeks and above
Key exclusion criteria (7 listed)
- Patients with hypertensive disorders of pregnancy having baseline systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 99 mmHg.
- Baseline mean arterial pressure less than 70 mmHg.
- Antepartum hemorrhage/intraoperative blood loss greater than 1000ml
- history indicative of cardiovascular or neurological disease.
- known fetal abnormality.
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 |
|---|---|---|
| Norepinephrine BolusProphylactic norepinephrine bolus of 8 micrograms will be administered right after spinal anesthesia induction. Rescue bolus of norepinephrine 4 micrograms will be administered in case of hypotension. | Drug | Group N |
| Phenylephrine bolusProphylactic phenylephrine bolus of 100 micrograms will be administered right after spinal anesthesia induction. Rescue bolus of phenylephrine 50 micrograms will be administered in case of hypotension. | Drug | Group P |
Primary outcome
Incidence of spinal anesthesia induced Hypotension
Time frame: From induction of spinal anesthesia till delivery of neonate
Prophylactic norepinephrine and phenylephrine boluses will be administered to both groups right after spinal anesthesia induction.greater than 80% drop of the Systolic blood pressure will be defined as hypotension.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Background: PubMed 38633922Nadella H, Islam A, Ina EA, Levin D, Bacoat-Jones T. The Management of Spinal and Epidural Anesthesia-Related Hypotension in the United States During Cesarean Childbirth. Cureus. 2024 Mar 17;16(3):e56340. doi: 10.7759/cureus.56340. eCollection 2024 Mar.
- Background: PubMed 15106218Ng K, Parsons J, Cyna AM, Middleton P. Spinal versus epidural anaesthesia for caesarean section. Cochrane Database Syst Rev. 2004;2004(2):CD003765. doi: 10.1002/14651858.CD003765.pub2.
- Individual participant dataSharing planned: Undecided. participants confidentiality
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine Bolus and Phenylephrine bolus in people with Spinal Anesthesia Induced Hypotension, run by Dow University of Health Sciences at 1 site in Pakistan.
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 7 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: looking for participants now, as of the sponsor's last update on 20 Feb 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rabia Kamal, MBBS (923342239607, rabiakamal.ae@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of spinal anesthesia induced Hypotension (time frame: From induction of spinal anesthesia till delivery of neonate). 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 NCT06836986, which also lists 2 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 20 Feb 2025.