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Completed

NCT Number: NCT02275897

Effect of Different Injection Speeds for Spinal Anaesthesia in Caesarean Section

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Tengku Ampuan Rahimah

Klang, Selangor, 41200, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Slow Speed of spinal injection

Procedure

Speed of injection over 60 seconds

Fast Speed of spinal injection

Procedure

Speed of injection over 15 seconds

Primary outcomes

  1. 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%

Secondary outcomes

  1. Use of vasoconstrictors

    Time frame: First 10 minutes after injection

  2. Adequacy of block

    Time frame: Time of surgery

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

Sponsors and collaborators

Lead sponsor

Ministry of Health, Malaysia

Other Gov

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 27, 2014
Registry last updated
Dec 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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