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Effect of Different Injection Speeds for Spinal Anaesthesia in Caesarean Section

Injection Speed of Spinal Anaesthesia for Asian Women Undergoing Lower Segmental Caesarean Section and the Incidence of Hypotension and/or Use of Vasopressors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02275897
Enrollment
77
Registered
2014-10-27
Start date
2013-03-31
Completion date
2014-11-30
Last updated
2014-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effects of; Anesthesia, Spinal and Epidural; in Pregnancy, Pregnancy

Keywords

Lower Segmental Caesarean Section (LSCS), Speed of Injection, Spinal Anaesthesia, Anesthesia

Brief 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.

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.

Interventions

PROCEDUREFast Speed of spinal injection

Speed of injection over 15 seconds

PROCEDURESlow Speed of spinal injection

Speed of injection over 60 seconds

Sponsors

Ministry of Health, Malaysia
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* at least 18 years of age * singleton term pregnancy * American Society of Anesthesiologists (ASA) class I-II

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of HypotensionFirst 10 minutes after injectionHow many patients will experience a drop in systolic Blood Pressure of greater than 20%

Secondary

MeasureTime frameDescription
Use of vasoconstrictorsFirst 10 minutes after injection
Adequacy of blockTime of surgeryTo determine if the anaesthetic is adequate for the surgery (no pain or movement experienced around the surgical field)

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026