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
1 other identifier
interventional
77
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pregnancy
Started Mar 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 15, 2014
CompletedFirst Posted
Study publicly available on registry
October 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedDecember 12, 2014
December 1, 2014
1.7 years
October 15, 2014
December 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Hypotension
How many patients will experience a drop in systolic Blood Pressure of greater than 20%
First 10 minutes after injection
Secondary Outcomes (2)
Use of vasoconstrictors
First 10 minutes after injection
Adequacy of block
Time of surgery
Study Arms (2)
Slow Speed
EXPERIMENTALSlow 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
EXPERIMENTALFast group patients will receive spinal injection over 15 seconds. Vital signs monitored every minute after injection. Hypotension is treated with IV Phenylephrine or Ephedrine.
Interventions
Eligibility Criteria
You may qualify if:
- at least 18 years of age
- singleton term pregnancy
- American Society of Anesthesiologists (ASA) class I-II
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Tengku Ampuan Rahimah
Klang, Selangor, 41200, Malaysia
Related Publications (1)
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.
PMID: 28494915DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Chun Fai Chiang, MBBS
Ministry of Health, Malaysia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Officer
Study Record Dates
First Submitted
October 15, 2014
First Posted
October 27, 2014
Study Start
March 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
December 12, 2014
Record last verified: 2014-12