PregnancyNCT02275897
Effect of Different Injection Speeds for Spinal Anaesthesia in Caesarean Section
A study testing Slow Speed of spinal injection and Fast Speed of spinal injection in people with Pregnancy and Effects of; Anesthesia, Spinal and Epidural; in Pregnancy, run by Ministry of Health, Malaysia at 1 site in Malaysia.
Trial summary
The purpose of this study is to investigate if prolonging the speed of injection during spinal anaesthesia can reduce the incidence of hypotension and/or medication requirements thereby making it safer for the mother and foetus. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Effects of; Anesthesia, Spinal and Epidural; in Pregnancy
- What is being tested?
- Slow Speed of spinal injection and Fast Speed of spinal injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteMalaysia
- Study dates
- Mar 2013to Nov 2014
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- singleton term pregnancy
- American Society of Anesthesiologists (ASA) class I-II
Who cannot join
- Severe pre-eclampsia
- contraindications to spinal anaesthesia
- Height <150cm or >180cm
- Weight ≥100kg
- Baseline systolic BP <90 mmHg
- Baseline systolic BP >150mmHg
- Category 1 urgency for delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Injection Speed of Spinal Anaesthesia for Asian Women Undergoing Lower Segmental Caesarean Section and the Incidence of Hypotension and/or Use of Vasopressors
The purpose of this study is to investigate if prolonging the speed of injection during spinal anaesthesia can reduce the incidence of hypotension and/or medication requirements thereby making it safer for the mother and foetus.
Read the detailed description
We plan to investigate if by varying the speed of injection during spinal anaesthesia, will there be a difference in the incidence of hypotension. Hypotension is a common complication especially for pregnant women undergoing caesarean section. A high speed of injection can theoretically cause a higher spread of anaesthetic, which may increase the incidence of hypotension. We want to know if by prolonging the injection time, will this lead to a reduction in a rate of hypotension.
- Being tested
- Slow Speed of spinal injection, Fast Speed of spinal injection
- Keywords
- Lower Segmental Caesarean Section (LSCS), Speed of Injection, Spinal Anaesthesia, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow Speed of spinal injectionProcedure or surgery
Speed of injection over 60 seconds
Fast Speed of spinal injectionProcedure or surgery
Speed of injection over 15 seconds
| Study group | Role | What they receive |
|---|---|---|
| Slow Speed | Experimental | Slow group patients will receive spinal injection over 60 seconds. Vital signs monitored every minute after injection. Hypotension is treated with IV Phenylephrine or Ephedrine. Receives: Procedure: Slow Speed of spinal injection |
| Fast Speed | Experimental | Fast group patients will receive spinal injection over 15 seconds. Vital signs monitored every minute after injection. Hypotension is treated with IV Phenylephrine or Ephedrine. Receives: Procedure: Fast Speed of spinal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hypotension
How many patients will experience a drop in systolic Blood Pressure of greater than 20%
Measured: First 10 minutes after injection
Secondary outcomes (2)
Use of vasoconstrictors
Measured: First 10 minutes after injection
Adequacy of block
To determine if the anaesthetic is adequate for the surgery (no pain or movement experienced around the surgical field)
Measured: Time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startMar 2013
- Primary completionNov 2014
- Study completionNov 2014
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 PregnancyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Chiang CF, Ministry of Health, Malaysia
- Investigators
- Chun Fai Chiang, MBBS, Principal investigator, Ministry of Health, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275897
- Sponsor's protocol ID
- NMRR-13-608-16854 (IIR)
- Status last verified
- Dec 2014
- First submitted
- 15 Oct 2014
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Chiang CF, Hasan MS, Tham SW, Sundaraj S, Faris A, Ganason N. Injection speed of spinal anaesthesia for Caesarean delivery in Asian women and the incidence of hypotension: A randomised controlled trial. J Clin Anesth. 2017 Jun;39:82-86. doi: 10.1016/j.jclinane.2017.03.025. Epub 2017 Apr 1.
PubMed 28494915
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection Speed of Spinal Anaesthesia for Asian Women Undergoing Lower Segmental Caesarean Section and the Incidence of Hypotension and/or Use of Vasopressors
- ClinicalTrials.gov ID
- NCT02275897
- Acronym / sponsor ID
- NMRR-13-608-16854 (IIR)
- Keywords
- Lower Segmental Caesarean Section (LSCS), Speed of Injection, Spinal Anaesthesia, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Study start
- Mar 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 Oct 2014 (estimated)
- 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 purpose of this study is to investigate if prolonging the speed of injection during spinal anaesthesia can reduce the incidence of hypotension and/or medication requirements thereby making it safer for the mother and foetus.
Detailed description
We plan to investigate if by varying the speed of injection during spinal anaesthesia, will there be a difference in the incidence of hypotension. Hypotension is a common complication especially for pregnant women undergoing caesarean section. A high speed of injection can theoretically cause a higher spread of anaesthetic, which may increase the incidence of hypotension. We want to know if by prolonging the injection time, will this lead to a reduction in a rate of hypotension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow Speed | Experimental | Procedure: Slow Speed of spinal injectionSlow group patients will receive spinal injection over 60 seconds. Vital signs monitored every minute after injection. Hypotension is treated with IV Phenylephrine or Ephedrine. |
| Fast Speed | Experimental | Procedure: Fast Speed of spinal injectionFast group patients will receive spinal injection over 15 seconds. Vital signs monitored every minute after injection. Hypotension is treated with IV Phenylephrine or Ephedrine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years of age
- singleton term pregnancy
- American Society of Anesthesiologists (ASA) class I-II
Key exclusion criteria (7 listed)
- Severe pre-eclampsia
- contraindications to spinal anaesthesia
- Height <150cm or >180cm
- Weight ≥100kg
- Baseline systolic BP <90 mmHg
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 |
|---|---|---|
| Slow Speed of spinal injectionSpeed of injection over 60 seconds | Procedure or surgery | Slow Speed |
| Fast Speed of spinal injectionSpeed of injection over 15 seconds | Procedure or surgery | Fast Speed |
Primary outcome
Incidence of Hypotension
Time frame: First 10 minutes after injection
How many patients will experience a drop in systolic Blood Pressure of greater than 20%
2 secondary outcomes
Use of vasoconstrictors
Time frame: First 10 minutes after injection
Adequacy of block
Time frame: Time of surgery
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 12 Dec 2014.
- Derived from this study: PubMed 28494915Chiang CF, Hasan MS, Tham SW, Sundaraj S, Faris A, Ganason N. Injection speed of spinal anaesthesia for Caesarean delivery in Asian women and the incidence of hypotension: A randomised controlled trial. J Clin Anesth. 2017 Jun;39:82-86. doi: 10.1016/j.jclinane.2017.03.025. Epub 2017 Apr 1.
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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.
Chun Fai Chiang, MBBS principal investigator
Ministry of Health, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow Speed of spinal injection and Fast Speed of spinal injection in people with Pregnancy and Effects of; Anesthesia, Spinal and Epidural; in Pregnancy, run by Ministry of Health, Malaysia at 1 site in Malaysia.
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: finished, as of the sponsor's last update on 12 Dec 2014. 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 Malaysia. 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?
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 Hypotension (time frame: First 10 minutes after injection). 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 NCT02275897, 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 12 Dec 2014.