Effect of Different Injection Speeds for Spinal Anaesthesia in Caesarean Section

Ministry of Health, Malaysia

Status: Completed

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

Treatments: Procedure: Fast Speed of spinal injection; Procedure: Slow Speed of spinal injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02275897

NMRR-13-608-16854 (IIR)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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77 participants in 2 patient groups

Slow Speed

Experimental group

Description:

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.

Treatment:

Procedure: Slow Speed of spinal injection

Fast Speed

Experimental group

Description:

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.

Treatment:

Procedure: Fast Speed of spinal injection