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CompletedNCT02275897Updated Dec 12, 2014

Effect of Different Injection Speeds for Spinal Anaesthesia in Caesarean Section

An interventional study of Slow Speed of spinal injection and Fast Speed of spinal injection in Pregnancy and Effects of; Anesthesia, Spinal and Epidural; in Pregnancy, sponsored by Ministry of Health, Malaysia. Completed at 1 site in Malaysia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-12.

Sponsored by Ministry of Health, Malaysia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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 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.

02

Conditions studied

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

Keywords

  • Lower Segmental Caesarean Section (LSCS)
  • Speed of Injection
  • Spinal Anaesthesia
  • Anesthesia
03

In context

Lead sponsor

Ministry of Health, Malaysia is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
77 participants (actual)

Study arms

  • Experimental
    Slow Speed

    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.

    Procedure: Slow Speed of spinal injection

  • Experimental
    Fast Speed

    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.

    Procedure: Fast Speed of spinal injection

Interventions

  • ProcedureSlow Speed of spinal injection

    Speed of injection over 60 seconds

  • ProcedureFast Speed of spinal injection

    Speed of injection over 15 seconds

06

What researchers measure

Primary outcomes

  1. Incidence of Hypotension

    How many patients will experience a drop in systolic Blood Pressure of greater than 20%

    Time frame: First 10 minutes after injection

Secondary outcomes

  1. Use of vasoconstrictors

    Time frame: First 10 minutes after injection

  2. Adequacy of block

    To determine if the anaesthetic is adequate for the surgery (no pain or movement experienced around the surgical field)

    Time frame: Time of surgery

07

Study locations

1 site
  • Hospital Tengku Ampuan Rahimah
    Klang, Selangor 41200, Malaysia
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02275897
Lead sponsor
Ministry of Health, Malaysia
Responsible party
Dr. Chiang CF (Medical Officer, Ministry of Health, Malaysia) — Principal investigator
First posted
Oct 27, 2014
Start date
Mar 2013
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Dec 12, 2014

Study contacts

Chun Fai Chiang, MBBS
principal investigator · Ministry of Health, Malaysia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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