BradycardiaPhase 4NCT04069078
Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section
A Phase 4 study testing Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule and Normal saline in people with Bradycardia and Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the efficacy of Iv hyoscine butylbromide in preventing Bradycardia during cesarean section under spinal anaesthesia with local anaesthetic and morphine. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Bradycardia, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, Cesarean Section Complications
- What is being tested?
- Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2019to 25 Feb 2020
- 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
- ASA physical status class I-II.
- Age: 18 Years to 40 Years.
- Women scheduled for elective Cesarean section under spinal anesthesia.
- indications for CS other than fetal or maternal pathology.
Who cannot join
- Height < 150 or > 180 cm
- Body mass index (BMI) >35 kg/m2
- Contraindication for central neuraxial block
- Refusal to undergo regional anesthesia
- Known allergy to any of the study drugs,
- Infection at the site of injection,
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- Coagulopathy,
- Indication to general anesthesia
- Baseline bradycardia (heart rate < 60/min), or any cardiovascular disease
- Patients taking β-adrenergic blockers or any drugs that may alter normal response to study drugs.
- Arrhythmia such as atrial fibrillation, supraventricular tachycardia, heart block greater than first degree, left bundle branch block,
- Hypertension (systolic blood pressure more than 140 mm Hg or diastolic blood pressure more than 90 mm Hg), unstable angina or cardiomyopathy,
- Associated medical problem with pregnancy (as hypertension, diabetes mellitus, hepatic impairment or renal impairment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Use of Iv Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section Under Spinal Anaesthesia. a Randomized Controlled Trial
The aim of this study is to assess the efficacy of Iv hyoscine butylbromide in preventing Bradycardia during cesarean section under spinal anaesthesia with local anaesthetic and morphine.
- Conditions
- Bradycardia, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, Cesarean Section Complications
- Being tested
- Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule, Normal saline
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyoscine Butylbromide 20 Mg/mL Solution for Injection AmpouleDrug
Patients will receive IV study solution which is hyoscine butylbromide 20 mg in 1 ml one minute after spinal anaesthesia
Normal salineOther
Patients will receive 1 ml of IV normal saline as a placebo one minute after spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Hyoscine butylbromide | Active comparator | Not described Receives: Drug: Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule |
| Control | Placebo comparator | Not described Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bradycardia
number of participants who will develop heart rate below 50 BPM.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start10 Oct 2019
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
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 BradycardiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Samy Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069078
- Sponsor's protocol ID
- hyoscine
- Status last verified
- Mar 2020
- First submitted
- 23 Aug 2019
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abbas MS, Hassan SA, Abbas AM, Thabet AM, Thabet AM, Mahdy MM. Hemodynamic and antiemetic effects of prophylactic hyoscine butyl-bromide during cesarean section under spinal anesthesia: a randomized controlled trial. BMC Anesthesiol. 2022 Apr 21;22(1):112. doi: 10.1186/s12871-022-01659-9.
PubMed 35448942
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Use of Iv Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section Under Spinal Anaesthesia. a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04069078
- Acronym / sponsor ID
- hyoscine
- Conditions
- Bradycardia, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, Cesarean Section Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 28 Aug 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.
The aim of this study is to assess the efficacy of Iv hyoscine butylbromide in preventing Bradycardia during cesarean section under spinal anaesthesia with local anaesthetic and morphine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyoscine butylbromide | Active comparator | Drug: Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule |
| Control | Placebo comparator | Other: Normal saline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA physical status class I-II.
- Age: 18 Years to 40 Years.
- Women scheduled for elective Cesarean section under spinal anesthesia.
- indications for CS other than fetal or maternal pathology.
Key exclusion criteria (13 listed)
- Height < 150 or > 180 cm
- Body mass index (BMI) >35 kg/m2
- Contraindication for central neuraxial block
- Refusal to undergo regional anesthesia
- Known allergy to any of the study drugs,
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 |
|---|---|---|
| Hyoscine Butylbromide 20 Mg/mL Solution for Injection AmpoulePatients will receive IV study solution which is hyoscine butylbromide 20 mg in 1 ml one minute after spinal anaesthesia | Drug | Hyoscine butylbromide |
| Normal salinePatients will receive 1 ml of IV normal saline as a placebo one minute after spinal anesthesia | Other | Control |
Primary outcome
Bradycardia
Time frame: intraoperative
number of participants who will develop heart rate below 50 BPM.
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 3 Mar 2020.
- Derived from this study: PubMed 35448942Abbas MS, Hassan SA, Abbas AM, Thabet AM, Thabet AM, Mahdy MM. Hemodynamic and antiemetic effects of prophylactic hyoscine butyl-bromide during cesarean section under spinal anesthesia: a randomized controlled trial. BMC Anesthesiol. 2022 Apr 21;22(1):112. doi: 10.1186/s12871-022-01659-9.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule and Normal saline in people with Bradycardia and Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 13 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 3 Mar 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Bradycardia (time frame: intraoperative). 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 NCT04069078, 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 3 Mar 2020.